Type of PAC - Central Drugs Standard Control … of PAC (Supplement and Notifiable / Permission...
43
S. No Product Type of PAC (Supplement and Notifiable / Permission Granted by CDSCO) PAC Details Date of NOC 1 BCG vaccine Level-II Addition of new facility (Building no. 1, Filling Area 2, first floor) for the manufacturing activity of the BCG vaccine. 14.11.13 Level-III 1. To discontinue filling of BCG vaccine in building no. 1, filling area no. 1. 2. Revision of BCG QC MTR No. 035 6202: To make Oxygen uptake test as informative in specifications. 3. To replace the existing in house reference preparation of BCG vaccine batch no. PS002 with new in house reference preparation of BCG vaccine. 11863, dt. 11th Mar. 2011 Level-III 2. Excessive dermal reactivity test to be performed on 6 guinea pigs instead of 4. 2266, dt. 17th Jan. 2014 Level-III 3. Inclusion of “container / closure integrity test” in the finished product (filled in containers) specification. 2267, dt. 17th Jan. 2014 Level-III 4. Inclusion of “particulate matter (visual) test” in the finished product specification. 2276, dt. 17th Jan. 2014 Level-III 5. To tighten the acceptance criterion to assign release specification as 2-8 x 106 CFU/ml (four fold) for viability test of BCG vaccine (Freeze dried) instead of 1-33 x 106 CFU/ml, to be supplied to UN agencies, UNICEF, WHO, PAHO and other Private export orders. F. No. 12-80 / SIIL / PAC-BCG Vaccine / 14-BD, dt. 12th Dec. 2014 Level-III 6. The theoretical value of water in placebo (Monosodium Glutamate) is defined as per the molecular formula. Considering the quantity of this chemical added in the vaccine during manufacture, a calculation has been deduced to elucidate the contribution of water from it and its subsequent deduction from total water content of product to obtain moisture content of only the vaccine. 739, dt. 8th Jan. 2015 Level-III 7. As per I.P. 2014, B.P. 2014 and WHO/TRS/979 (2013) under test for Final lot it has been mentioned that, “Provide the test excessive dermal reactivity has been carried out with satisfactory results 744, dt. 8th Jan. 2015
Transcript of Type of PAC - Central Drugs Standard Control … of PAC (Supplement and Notifiable / Permission...
S. No Product
Type of PAC (Supplement and
Notifiable / Permission Granted
by CDSCO)
PAC Details Date of NOC
1 BCG vaccine
Level-II
Addition of new facility (Building no. 1, Filling Area 2, first floor) for the manufacturing activity of the BCG vaccine.
14.11.13
Level-III
1. To discontinue filling of BCG vaccine in building no. 1, filling area no. 1.2. Revision of BCG QC MTR No. 035 6202: To make Oxygen uptake test as informative in specifications.3. To replace the existing in house reference preparation of BCG vaccine batch no. PS002 with new in house reference preparation of BCG vaccine.
11863, dt. 11th Mar. 2011
Level-III2. Excessive dermal reactivity test to be performed on 6 guinea pigs instead of 4.
2266, dt. 17th Jan. 2014
Level-III3. Inclusion of “container / closure integrity test” in the finished product (filled in containers) specification.
2267, dt. 17th Jan. 2014
Level-III4. Inclusion of “particulate matter (visual) test” in the finished product specification.
2276, dt. 17th Jan. 2014
Level-III
5. To tighten the acceptance criterion to assign release specification as 2-8 x 106 CFU/ml (four fold) for viability test of BCG vaccine (Freeze dried) instead of 1-33 x 106 CFU/ml, to be supplied to UN agencies, UNICEF, WHO, PAHO and other Private export orders.
F. No. 12-80 / SIIL / PAC-BCG Vaccine /
14-BD, dt. 12th Dec. 2014
Level-III
6. The theoretical value of water in placebo (Monosodium Glutamate) is defined as per the molecular formula. Considering the quantity of this chemical added in the vaccine during manufacture, a calculation has been deduced to elucidate the contribution of water from it and its subsequent deduction from total water content of product to obtain moisture content of only the vaccine.
739, dt. 8th Jan. 2015
Level-III
7. As per I.P. 2014, B.P. 2014 and WHO/TRS/979 (2013) under test for Final lot it has been mentioned that, “Provide the test excessive dermal reactivity has been carried out with satisfactory results
744, dt. 8th Jan. 2015
on the working seed lot on 5 consecutive lots produced from it, the test may be omitted on the final lot”. Accordingly we have sufficient data of satisfactory test results for excessive dermal reactivity till date as we were performing it on each final lot.
Level-III
8. To assign release specifications as 2-8 x 106 CFU/ml (four fold) for viability test of BCG vaccine instead of 1-33 x 106 CFU/ml to be supplied to UN Agencies, UNICEF, WHO, PAHO and other private export orders.
F. No. 12-80 / SIIL / PAC-BCG vaccine / 14-BD, dt. 3rd Feb.
2015
Level-III
9. Usage of theoretical value of Monosodium Glutamate for calculation of residual moisture content in BCG vaccine
F. No. 12-70 / SIIL / PAC-BCG Vaccine /
15-BD, dt. 17th Apr. 2015
Level-III
10. To assign release specification of viability test of BCG vaccine, freeze dried final product to be supplied to domestic market (I.P.) in line with revised I.P. addendum 2015 as 2-8 x 105 CFU/0.1 ml (four fold).
F. No. 12-112 / SIIL / PAC-BCG / 15-BD, dt.
9th Nov. 2015
Level-III11. Deletion of test in the finished product specification for BCG vaccine (Freeze Dried).
F. No. 12-32 / SIIL / PAC-BCG vaccine /
15-BD, dt. 17th Jan. 2015
Level-III
12. Residual solvent test is not stated in the monograph (USP-NF), hence will be excluded from the specification of Monosodium Glutamate – USP-NF.
8107, dt. 7th Mar. 2016
Level-III
13. To initiate filling and lyophilization of BCG vaccine (Freeze dried) in Building No. 1, first floor, filling area no. 2 (already approved multi product manufacturing area).
1048, dt. 12th Jan. 2017
Level-III14. Deletion of dispersion test at the intermediate stage of finished product for BCG vaccine.
F. No. 12-34 / SIIL / PAC-BCG Vaccine /
15-BD, dt. 17th Mar. 2015
2
Diptheria and Tetanus Vaccine
(Adsorbed) (Paediatrics)
Level I
1. Permission to use semi-synthetic media (meat free) for the production of Diptheria & Tetanus toxoids (bulk) which are active ingredients for our Tetanus and Diphtheria containing combination vaccine
04.12.2008
(NOC F.No: 4-SII-36/MF DTP/07-DC)
Level II
1. To use of Sartron Hydrosart cassettes for microfiltration as an additional source to the currently used Prostak filtration modules for clarification of Diptheria Broth
28.02.2014
(NOC F.No: 12-116/SII/PAC-Diptheria (Broth) /13-BD)
Level-III
1. Reduction of injection dose from “1.0 mL” to “0.5 mL” in guinea pigs for abnormal toxicity test of final lot of Diphtheria and Tetanus Vaccine (Adsorbed) I.P.as per WHO TRS 800 and I.P. - 2010.
24.01.2013
(Acknowledged vide letter no. 3437)
Level-III
2. Relocation of heavy duty refrigerated centrifuge EQ ID DB 0 114 56 0 20 (make: Sorvall) from Diphtheria block located at Building No 6 First Floor (FF) to Toxoid purification facility located at Building no 7, Ground floor (GF) The relocated centrifuge is identical to the centrifuge in use for manufacturing of purified Tetanus toxoid.
24.01.2013
(Acknowledged vide letter no. 3432)
Level-III
3. Reduction of injection dose from “1.0 mL” to “0.5 mL” in guinea pigs for abnormal toxicity test of final lot of Diphtheria and Tetanus Vaccine (Adsorbed) I.P. [Thiomersal Free] as per WHO TRS 800 and I.P. - 2010.
24.01.2013
(Acknowledged vide letter no. 3442)
Level-III
4. To discontinue the in-process testing for microbial contamination detection (MCDT) on the dispensed antigens (Diptheria and Tetanus Toxoids) and presevative (2 % thiomersal solution) for Diptheria and Teatanus vaccine (Adsorbed) I.P.
27.01.2014
(Acknowledgement No 3726 )
Level-III
5. To discontinue the in-process testing for microbial contamination detection (MCDT) on the dispensed antigens (Diptheria and Tetanus Toxoids) and presevative (2 % thiomersal solution) for Diptheria and Teatanus vaccine (Adsorbed) I.P. (Thiomersal Free)
27.01.2014
(Acknowledgement No 3727 )
Level-III6. Inclusion of "Container / closure integrity" test in the finished product
28.01.2014
specification for (Diptheria and Tetanus vaccine (Adsorbed) I.P.)
(Acknowledgement No 3943)
Level-III
7. Inclusion of "Container / closure integrity" test in the finished product specification for (Diptheria and Tetanus vaccine (Adsorbed) I.P.) [thiomersal Free] (CH13-214)
29.01.2014
(Acknowledgement No 4150)
Level-III
8. Inclusion of "Particulate matter (visual) test in the finished product specification" (Diptheria and Tetanus vaccine (Adsorbed) I.P.)
27.01.2014
(Acknowledgement No 3722)
Level-III
9. Inclusion of "Particulate matter (visual) test in the finished product specification" (Diptheria and Tetanus vaccine (Adsorbed) I.P.) [thiomersal Free].
27.01.2014
(Acknowledgement No 3723)
Level-III
10. To reduce the concentration of thiomersal in purified Tetanus toxoidpool from 0.001 % to 0.005 % 28.01.2014
(Acknowledgement No 3945)
Level-III
11. To reduce the concentration of thiomersal in purified Diptheria Toxoid from 0.001 % to 0.005 % 28.01.2014
(Acknowledgement No 3946 )
Level-III
12. Elimination of pooling process from manufacturing of purified Toxoid. Identifying of existing "Purified Tetanus Toxoid Lot" as "Purified Tetanus Toxoid" which Is directly used for drug product manufacturing
08.01.2015
(Acknowledgement No 741)
Level-III
13. To reduce the concentration of thiomersal from 0.01 % to 0.005 % in purified Diptheria and Tetanus vaccine (Adsorbed) (Pediatric). 19.06.2015
(NOC F.No: 12-77/SIIL/PAC-DT Pediatric vaccine / 15-BD
Level-III
14. To incorporate the following in T-ELISA procedure for potency estimation of Tetanus component: I) Test sample validity criteria. 2) Comparability of each new conjugate lot is demonstrated by performing two independent assays using old and new conjugate lots. 3) To prepare and run positive control in each test to
13.01.2016
establish the assay validity. for Diphtheria and Tetanus Vaccine Adsorbed (Paediatric)
(Acknowledgement No 1174)
Level-III
15. To remove the step of checking specific gravity of bulk liquid every day before filling for Diphtheria and Tetanus Vaccine Adsorbed (Paediatric)
13.01.2016
(Acknowledgement No 1171)
Level-III
16. To start using OPC (One Point Cut) ampoules, in place of existing "Snap Off' ampoules, for Diptheria and Tetanus (PediatricThiomersal free) Vaccine l.P.
12.01.2017
(Acknowledgement No 1059)
Level-III
17. To start using OPC (One Point Cut) ampoules, in place of existing "Snap Off' ampoules, for Diptheria and Tetanus (Adsorbed) vaccine I.P.
12.01.2017
(Acknowledgement No 1046)
3
Diphtheria, Tetanus and
Pertussis vaccine
(Adsorbed)
Level I
1. Permission to use semi-synthetic media (meat free) for the production of Diptheria & Tetanus toxoids (bulk) which are active ingredients for our Tetanus and Diphtheria containing combination vaccine
04.12.2008
(NOC F.No: 4-SII-36/MF DTP/07-DC)
Level I
2. Application involving production of Pertussis (Whole Cell) Bulk vaccine using fermenter in addition to currently being used Shake Flask 24.06.2014
(NOC F.No: 12-18/SIII/PAC-Pertussis (bulk)/14-BD)
Level II
1. Application for cell concentration process by using tangential flow filtration system as an additional method to centrifugation for Pertussis (whole cell) bulk vaccine manufacturing
21.01.2014
(NOC F.No: 12-115/SII/PAC-Pertussis (bulk)/13-BD)
Level II
9. To use of Sartron Hydrosart cassettes for microfiltration as an additional source to the currently used Prostak filtration modules for clarification of Diptheria Broth
28.02.2014
(NOC F.No: 12-116/SII/PAC-Diptheria (Broth) /13-BD)
Level-III
1. Relocation of heavy duty refrigerated centrifuge EQ ID DB 0 114 56 0 20 (make: Sorvall) from Diphtheria block located at Building No 6 First Floor (FF) to Toxoid purification facility located at Building no 7, Ground floor (GF) The relocated centrifuge is identical to the centrifuge in use for manufacturing of purified Tetanus toxoid.
24.01.2013
(Acknowledged vide letter no. 3432)
Level III
2. Application for reduction of injection dose from 1.0 ml to 0.5 ml in guinea pigs for abnormal toxicity test of final lot for Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed)
04.03.2013
(NOC F.No: 12-25/SERUM/PAC-DTP /13-BD)
Level-III
3. Inclusion of "Particulate matter (visual) test in the finished product specification" for (Diptheria and Tetanus and Pertussis vaccine (adsorbed) I.P. [DTP]) (CH13-172)
27.01.2014
(Acknowledgement No 3715)
Level-III
4. Intimation of Level III change for Revival of one working seed tube (WSL) of each B-Pertussis strain Nos. 134, 509, 6229, 25525 and used for the preparation of one mixing vessel pool (MVP) of each facility instead of used for preparation of one lot fo each facility
27.01.2014
(Acknowledgement No 3724)
Level-III
5. To discontinue the in-process testing for microbial contamination detection (MCDT) on the dispensed antigens (Diptheria and Tetanus Toxoids) and presevative (2 % thiomersal solution) for (Diptheria, Tetanus and Pertussis (whole cell vaccine (Adsorbed) I.P.)
27.01.2014
(Acknowledgement No 3725)
Level-III
6. To reduce the concentration of thiomersal in purified tetanus Toxoidfrom 0.001 % to 0.005 % 28.01.2014
(Acknowledgement No 3945 )
Level-III
7. To reduce the concentration of thiomersal in purified Diptheria Toxoid from 0.001 % to 0.005 % 28.01.2014
(Acknowledgement No 3946 )
Level-III
8. Inclusion of "Particulate matter (visual) test in the finished product specification" (Diptheria, Tetanus and Pertussis vaccine (Adsorbed) I.P.)
29.01.2014
(Acknowledgement No 4148)
Level-III
9. Elimination of Pooling process from manufaturing of purified tetanus toxoid Identifying of existing "Purified Tetanus Toxoid" which is directly used for drug product manufacturing
08.01.2015
(Acknowledgement No 741 )
Level-III
10. To remove the step of checking specific gravity of bulk liquid every day before filling for Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed)
08.01.2015
(Acknowledgement No 733)
Level-III
11. Intimation of Level III change to pool and centrifugation of the harvested production flaskin four sublots instead of three sublots for Pertussis bulk vaccine
08.01.2015
(Acknowledgement No 743)
Level-III
12. To reduce the concentration of thiomersal from 0.01 % to 0.005 % in Diphtheria, Tetanus and Pertussis vaccine (Adsorbed) I.P. 09.09.2015
(NOC F.No: 12-27/SIIL/PAC-DTP vaccine / 15-BD
Level-III
13. To incorporate the following in T-ELISA procedure for potency estimation of Tetanus component: I) Test sample validity criteria. 2) Comparability of each new conjugate lot is demonstrated by performing two independent assays using old and new conjugate lots. 3) To prepare and run positive control in each test to establish the assay validity. for Diphtheria, Tetanus and Pertussis vaccine Adsorbed
13.01.2016
(Acknowledgement No 1310)
Level-III
14. To remove the step of checking specific gravity of bulk liquid every day before filling for Diphtheria, Tetanus and Pertussis Vaccine Adsorbed I.P.
11.01.2017
(Acknowledgement No 916)
Level-III
15. To start using OPC (One Point Cut) ampoules, in place of existing "Snap Off' ampoules, for Diphtheria, Tetanus and Pertussis Vaccine Adsorbed I.P.
11.01.2017
(Acknowledgement No 920)
Level-III
16. Intimation of Level III annual notifiable change of Installation of new Deep-Freezer (make kaltis, capacity 390L) in pertussis vaccine department Building No 6 Ground Floor Storage of Master and Working cultures of Bordetella pertussis in deep freezer at ≤ -20 degree instead of + 2 to 8 degree centigrade.
12.01.2017
(Acknowledgement No 1044)4 DTP+Hib
Level I
1. Permission to use semi-synthetic media (meat free) for the production of Diptheria & Tetanus toxoids (bulk) which are active ingredients for our Tetanus and Diphtheria containing combination vaccine
04.12.2008
(NOC F.No: 4-SII-36/MF DTP/07-DC)
Level I
2. Application involving production of Pertussis (Whole Cell) Bulk vaccine using fermenter in addition to currently being used Shake Flask 24.06.2014
(NOC F.No: 12-18/SIII/PAC-Pertussis (bulk)/14-BD)
Level II
1. Application for cell concentration process by using tangential flow filtration system as an additional method to centrifugation for Pertussis (whole cell) bulk vaccine manufacturing
21.01.2014
(NOC F.No: 12-115/SII/PAC-Pertussis (bulk)/13-BD)
Level II
2. To use of Sartron Hydrosart cassettes for microfiltration as an additional source to the currently used Prostak filtration modules for clarification of Diptheria Broth
28.02.2014
(NOC F.No: 12-116/SII/PAC-Diptheria (Broth) /13-BD)
Level-III
1. Relocation of heavy duty refrigerated centrifuge EQ ID DB 0 114 56 0 20 (make: Sorvall) from Diphtheria block located at Building No 6 First Floor (FF) to Toxoid purification facility located at Building no 7, Ground floor (GF) The relocated centrifuge is identical to the centrifuge in use for manufacturing of purified Tetanus toxoid.
24.01.2013
(Acknowledged vide letter no. 3432)
Level-III2. Inclusion of "Particulate matter (visual) test in the finished product specification"
27.01.2014
for (Diptheria and Tetanus and Pertussis and Haemophilus Type b conjugatevaccine (adsorbed) I.P.(Acknowledgement No 3718)
Level-III
3. Intimation of Level III change for Revival of one working seed tube (WSL) of each B-Pertussis strain Nos. 134, 509, 6229, 25525 and used for the preparation of one mixing vessel pool (MVP) of each facility instead of used for preparation of one lot fo each facility
27.01.2014
(Acknowledgement No 3724)
Level-III
4. Inclusion of "Container / closure integrity" test in the finished product specification for (Diptheria, Tetanus and Pertussis (whole cell) and Haemophilus influenzae type b conjugate vaccine (Adsorbed) I.P.)
28.01.2014
(Acknowledgement No 3939)
Level-III
5. To reduce the concentration of thiomersal in purified tetanus Toxoidfrom 0.001 % to 0.005 % 28.01.2014
(Acknowledgement No 3945 )
Level-III
6. To reduce the concentration of thiomersal in purified Diptheria Toxoid from 0.001 % to 0.005 % 28.01.2014
(Acknowledgement No 3946 )
Level-III
7. To discontinue the in-process testing for microbial contamination detection (MCDT) on the dispensed antigens (Diptheria and Tetanus Toxoids) and presevative (2 % thiomersal solution) for (Diptheria, Tetanus and Pertussis (whole cell) and Haemophilus influenzae type b conjugate vaccine (Adsorbed) I.P.)
29.01.2014
(Acknowledgement No 4154)
Level-III
8. Elimination of Pooling process from manufaturing of purified tetanus toxoidIdentifying of existing "Purified Tetanus Toxoid" which is directly used for drug product manufacturing
08.01.2015
(Acknowledgement No 741 )
Level-III
9. Intimation of Level III change to pool and centrifugation of the harvested production flaskin four sublots instead of three sublots for Pertussis bulk vaccine
08.01.2015
(Acknowledgement No 743)
Level-III
10. To reduce the concentration of thiomersal from 0.01 % to 0.005 % in Diphtheria, Tetanus, Pertussis and Haemophilus Influenzatype b conjugate vaccine (Adsorbed) I.P.
08.03.2016
(NOC F.No: 12-27/SIIL/PAC-DTP vaccine / 15-BD
Level-III
11. To remove the step of checking specific gravity of bulk liquid every day before filling for Diphtheria, Tetanus, Pertussis (Whole Cell) and Haemophilus Type b Conjugate Vaccine Adsorbed I.P.
11.01.2017
(Acknowledgement No 918)
Level-III
12. Intimation of Level III annual notifiable change of Installation of new Deep-Freezer (make kaltis, capacity 390L) in pertussis vaccine department Building No 6 Ground Floor Storage of Master and Working cultures of Bordetella pertussis in deep freezer at ≤ -20 degree instead of + 2 to 8 degree centigrade.
12.01.2017
(Acknowledgement No 1044)Changes for Haemophilus Type b Conjugate vaccine (Adsorbed) I.P.
Level II
3. Change in the manufacturing process of Haemophilus influenza type B (PRP-TT) conjugate vaccine for the use of TT developed in meat free semi synthetic medium.
30.11.2010
NOC F. No. PAC/SII/HIB /1/ 10-BD
Level II
4. Replacement of heat inactivation step with formalin for fermentation of Haemophilus influenza type b bulk. 21.03.2011
F. No. PAC/SII/Hib /2/ 10-BD
Level II
5. Change in the composition of container closure system for Haemophilus influenza type B conjugate vaccine. 21.09.2011F. No. 04-138 / 04-DC /(PAC-CCS-HIB) / 11-BD,
Level-II
6. Amendment in ‘condition no. 2’ of the permission granted for ‘change in the composition of container closure system for Haemophilus influenza type B conjugate vaccine.
25.11.2011
F. No. 04-138 / 04-DC /(PAC-CCS-HIB) / 11-BD
Level-II
7. Introduction of M/s. Aptar Stelmi as an additional supplier for stoppers made with similar formulation as bromobutyl 6740GS to the existing supplier i.e. M/s. Datwyler (Helvoet) supplying stoppers with formulation as bromobutyl FM 460.
19.07.2016
F. No. 12-120 / SIIPL/ PAC/ PAC-Meningococcal /16-BD
Level-II
8. Amendment in ‘file no.’ of the permission granted for ‘Introduction of M/s. Aptar Stelmi as an additional supplier for stoppers made with similar formulation as bromobutyl 6740GS to the existing supplier i.e. M/s. Datwyler (Helvoet) supplying stoppers with formulation as bromobutyl FM 460’
20.10.2016
F. No. 12-53/SIIL/ PAC-Hib / 16-BD
Level-II
9. Increase in Hib Polysaccharide input from 74 g to 110 g for Hib PRP-TT-Conjugation process. 21.01.2015
F. No. 12-53/SIIL / PAC-Hib / 14-BD,
'Level-III
13. To include test for formaldehyde estimation on purified polysaccharide (PRP) of Haemophilus influenzae type b. Typographical correction in Hibfermentation BMR in the section of BOM. Typographical correction in primary recovery BMR in the section of BOM. Sterility test of Hib conjugate bulk will be put up by direct inoculation instead of membrane filtration method. Revision of BMRs for inoculum stages (S1, S2, S3), fermentation stage (S4) for Hib fermentors.
13.01.2010
Acknowledgement No 1618
Level-III
14. Tightening of in house specification for Total PRP content as NLT 0.25 mg/ml and total protein content as NLT 0.46 mg/ml for Hib bulk conjugate. 20.03.2012
F. No. 04-138 / 04-DC / (PAC-SCP-HIB) 11-BD
Level-III
15. To start fermentation and purification of Hib Polysaccharide in PCV facility, building no. SEZ-3 at same scale as in existing PCV facility in building no. SEZ-1B.
04.04.2012
F. No. 04-138 / 04-DC/ (PAC-Facility-Hib Type B) / 11-BD
Level-III
16. Transfer of ultra filtration system from DSP II area to DSP I area, incorporation of tank for use in conjugation activity from purification area used in the production of Hib type b conjugate vaccine.
03.05.2012
F. No. 04-138 / 04-DC / (PAC-CEQP-HIB) / 11-BD
Level-III
17. Transfer of centrifuge and ultra filtration system form one to another room within the same facility. 15.05.2012F. No. 04-138 / 04-DC / (PAC-CEQP-HIB) / 11-BD
Level-III
18. Inclusion of ‘container / closure integrity test’ in finished product (filled in containers) specification. 27.01.2014
Acknowledgement No 3719
Level-III
19. Inclusion of ‘particulate matter (visual) test’ in finished product specification. 27.01.2014
Acknowledgement No 3720
Level-III
20. Tighten the storage temperature of Haemophilus influenza type b bulk conjugate (Drug substance) from +2 to 8°C to -70°C. 09.11.2015
F. No. 12-107 / SIIL / PAC-Hib Bulk (DS) / 15-BD
5
Diphtheria, Tetanus, Pertussis
(Whole Cell) and Hepatitis B (rDNA) Vaccine
(Adsorbed).
Level I
1. Permission to use semi-synthetic media (meat free) for the production of Diptheria & Tetanus toxoids (bulk) which are active ingredients for our Tetanus and Diphtheria containing combination vaccine
04.12.2008
(NOC F.No: 4-SII-36/MF DTP/07-DC)
Level I
2. Application involving production of Pertussis (Whole Cell) Bulk vaccine using fermenter in addition to currently being used Shake Flask 24.06.2014
(NOC F.No: 12-18/SIII/PAC-Pertussis (bulk)/14-BD)
Level II
1. Application for cell concentration process by using tangential flow filtration system as an additional method to centrifugation for Pertussis (whole cell) bulk vaccine manufacturing
21.01.2014
(NOC F.No: 12-115/SII/PAC-Pertussis (bulk)/13-BD)
Level II
2. To use of Sartron Hydrosart cassettes for microfiltration as an additional source to the currently used Prostak filtration modules for clarification of Diptheria Broth
28.02.2014
(NOC F.No: 12-116/SII/PAC-Diptheria (Broth) /13-BD)
Level-III
1. Relocation of heavy duty refrigerated centrifuge EQ ID DB 0 114 56 0 20 (make: Sorvall) from Diphtheria block located at Building No 6 First Floor (FF) to Toxoid purification facility located at Building no 7, Ground floor (GF) The relocated centrifuge is identical to the centrifuge in use for manufacturing of purified Tetanus toxoid.
24.01.2013
(Acknowledged vide letter no. 3432)
Level-III
2. Inclusion of "Particulate matter (visual) test in the finished product specification" for (Diptheria, Tetanus and Pertussis and Hepatitis B (rDNA) vaccine (adsorbed) I.P.
27.01.2014
(Acknowledgement No 3717)
Level-III
3. Intimation of Level III change for Revival of one working seed tube (WSL) of each B-Pertussis strain Nos. 134, 509, 6229, 25525 and used for the preparation of one mixing vessel pool (MVP) of each facility instead of used for preparation of one lot fo each facility
27.01.2014
(Acknowledgement No 3724)
Level-III
4. Inclusion of "Container / closure integrity" test in the finished productspecification for (Diptheria, Tetanus and Pertussis and Hepatitis B (rDNA) vaccine (adsorbed) I.P.
28.01.2014
(Acknowledgement No 3940)
Level-III
5. To reduce the concentration of thiomersal in purified tetanus Toxoidfrom 0.001 % to 0.005 % 28.01.2014
(Acknowledgement No 3945 )
Level-III
6. To reduce the concentration of thiomersal in purified Diptheria Toxoid from 0.001 % to 0.005 % 28.01.2014
(Acknowledgement No 3946 )
Level-III
7. To discontinue the in-process testing for microbial contamination detection (MCDT) on the dispensed antigens (Diptheria and Tetanus Toxoids) and
29.01.2014
presevative (2 % thiomersal solution) for (Diptheria, Tetanus and Pertussis and Hepatitis B (rDNA) vaccine (adsorbed) I.P.(Acknowledgement No 4155)
Level-III
8. To replace the existing fermentors(New Brunswick Scientific) with the Bioengineering fermentors in Hepatitis B Bulk manufacturing facility Building No 6, First Floor
08.01.2015
(Acknowledgement No 738)
Level-III
9. Elimination of Pooling process from manufaturing of purified tetanus toxoidIdentifying of existing "Purified Tetanus Toxoid" which is directly used for drug product manufacturing
08.01.2015
(Acknowledgement No 741 )
Level-III
10. Intimation of Level III change to pool and centrifugation of the harvested production flaskin four sublots instead of three sublots for Pertussis bulk vaccine
08.01.2015
(Acknowledgement No 743)
Level-III
11. To remove the step of checking specific gravity of bulk liquid every day before filling for Diphtheria, Tetanus, Pertussis and Hepatitis B Vaccine Adsorbed
12.01.2016
(Acknowledgement No 1029)
Level-III
12. To incorporate the following in T-ELISA procedure for potency estimation of Tetanus component: I) Test sample validity criteria. 2) Comparability of each new conjugate lot is demonstrated by performing two independent assays using old and new conjugate lots. 3) To prepare and run positive control in each test to establish the assay validity. for Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus influenzae type b conjugate Vaccine
13.01.2016
(Acknowledgement No 1175)
Level-III
13. Installation of new Deep-Freezer (Make:Kaltis, Capacity: 390 L) in pertussis vaccine department, Building No 6, Ground floor. Storage of Master and working cultures of Bordetel!a pertussis in deep freezer at - 20 °C instead of +2 to 8 °C
12.01.2017
(Acknowledgement No 1044)
6 Diphtheria, Tetanus, Pertussis
(Whole Cell), Hepatitis B (rDNA) and Haemophilus
Type b Conjugate Vaccine
(Adsorbed) (DTPHB+Hib)
Changes for Diphtheria, Tetanus, Pertussis (whole cell) and Hepatitis B (rDNA) vaccine (Adsorbed)
Level I
1. Permission to use semi-synthetic media (meat free) for the production of Diptheria & Tetanus toxoids (bulk) which are active ingredients for our Tetanus and Diphtheria containing combination vaccine
04.12.2008
(NOC F.No: 4-SII-36/MF DTP/07-DC)
Level I
2. Application involving production of Pertussis (Whole Cell) Bulk vaccine using fermenter in addition to currently being used Shake Flask 24.06.2014
(NOC F.No: 12-18/SIII/PAC-Pertussis (bulk)/14-BD)
Level II
1. Application for cell concentration process by using tangential flow filtration system as an additional method to centrifugation for Pertussis (whole cell) bulk vaccine manufacturing
21.01.2014
(NOC F.No: 12-115/SII/PAC-Pertussis (bulk)/13-BD)
Level II
2. To use of Sartron Hydrosart cassettes for microfiltration as an additional source to the currently used Prostak filtration modules for clarification of Diptheria Broth
28.02.2014
(NOC F.No: 12-116/SII/PAC-Diptheria (Broth) /13-BD)
Level-III
1.Relocation of heavy duty refrigerated centrifuge EQ ID DB 0 114 56 0 20 (make: Sorvall) from Diphtheria block located at Building No 6 First Floor (FF) to Toxoid purification facility located at Building no 7, Ground floor (GF) The relocated centrifuge is identical to the centrifuge in use for manufacturing of purified Tetanus toxoid.
24.01.2013
(Acknowledged vide letter no. 3432)
Level-III
2. Intimation of Level III change for Revival of one working seed tube (WSL) of each B-Pertussis strain Nos. 134, 509, 6229, 25525 and used for the preparation of one mixing vessel pool (MVP) of each facility instead of used for preparation of one lot fo each facility
27.01.2014
(Acknowledgement No 3724)
Level-III
3. To discontinue the in-process testing for microbial contamination detection (MCDT) on the dispensed antigens (Diptheria and Tetanus Toxoids) and presevative (2 % thiomersal solution) for (Diptheria, Tetanus and Pertussis (whole cell), Hepatitis B and Haemophilus influenzae type b conjugate vaccine (Adsorbed) I.P.)
28.01.2014
(Acknowledgement No 3941)
Level-III
4. To reduce the concentration of thiomersal in purified tetanus Toxoid from 0.001 % to 0.005 % 28.01.2014
(Acknowledgement No 3945 )
Level-III
5. To reduce the concentration of thiomersal in purified Diptheria Toxoid from 0.001 % to 0.005 % 28.01.2014
(Acknowledgement No 3946 )
Level-III
6. Inclusion of "Particulate matter (visual) test in the finished product specification" for (Diptheria, Tetanus and Pertussis (whole cell), Hepatitis B and Haemophilus influenzae type b conjugate vaccine (Adsorbed) I.P.)
28.01.2014
(Acknowledgement No 3948)
Level-III
7. Inclusion of "Container / closure integrity" test in the finished product specification for (Diptheria, Tetanus and Pertussis (whole cell), Hepatitis B and Haemophilus influenzae type b conjugate vaccine (Adsorbed) I.P.)
29.01.2014
(Acknowledgement No 4149)
Level-III
8. To replace the existing fermentors(New Brunswick Scientific) with the Bioengineering fermentors in Hepatitis B Bulk manufacturing facility Building No 6, First Floor
8.01.2015
(Acknowledgement No 738)
Level-III
9. Elimination of pooling process from manufacturing of purified Toxoid. Identifying of existing "Purified Tetanus Toxoid Lot" as "Purified Tetanus Toxoid" which Is directly used for drug product manufacturing
8.01.2015
(Acknowledgement No 741)
Level-III
10. To pool and centrifugation of the harvested production flasks in four sublots instead of three sub lots for Pertussis bulk vaccine.
8.01.2015
(Acknowledgement No 743)
Level-III
11. Intimation of Level III annual notifiable change of Installation of new Deep-Freezer (make kaltis, capacity 390L) in pertussis vaccine department Building No 6 Ground Floor Storage of Master and Working cultures of Bordetella pertussis in deep freezer at ≤ -20 degree instead of + 2 to 8 degree centigrade.
12.01.2017
(Acknowledgement No 1044)
Level-III
12. To remove the step of checking specific gravity of bulk liquid every day before filling for Diphtheria, Tetanus, Pertussis (Whole Cell),Hepatitis B (rONA) and Hacrnophilus Type b Conjugate Vaccine (Adsorbed) J.P.
12.01.2017
(Acknowledgement No 1057)Changes for Haemophilus Type b Conjugate vaccine (Adsorbed) I.P.
Level II
3. Change in the manufacturing process of Haemophilus influenza type B (PRP-TT) conjugate vaccine for the use of TT developed in meat free semi synthetic medium.
30.11.2010
NOC F. No. PAC/SII/HIB /1/ 10-BD
Level II
4. Replacement of heat inactivation step with formalin for fermentation of Haemophilus influenza type b bulk. 21.03.2011
F. No. PAC/SII/Hib /2/ 10-BD
Level II
5. Change in the composition of container closure system for Haemophilus influenza type B conjugate vaccine. 21.09.2011F. No. 04-138 / 04-DC /(PAC-CCS-HIB) / 11-BD,
Level-II
6. Amendment in ‘condition no. 2’ of the permission granted for ‘change in the composition of container closure system for Haemophilus influenza type B conjugate vaccine.
25.11.2011
F. No. 04-138 / 04-DC /(PAC-CCS-HIB) / 11-BD
Level-II
7. Introduction of M/s. Aptar Stelmi as an additional supplier for stoppers made with similar formulation as bromobutyl 6740GS to the existing supplier i.e. M/s. Datwyler (Helvoet) supplying stoppers with formulation as bromobutyl FM 460.
19.07.2016
F. No. 12-120 / SIIPL/ PAC/ PAC-Meningococcal /16-BD
Level-II
8. Amendment in ‘file no.’ of the permission granted for ‘Introduction of M/s. Aptar Stelmi as an additional supplier for stoppers made with similar formulation as bromobutyl 6740GS to the existing supplier i.e. M/s. Datwyler (Helvoet) supplying stoppers with formulation as bromobutyl FM 460’
20.10.2016
F. No. 12-53/SIIL/ PAC-Hib / 16-BD
Level-II
9. Increase in Hib Polysaccharide input from 74 g to 110 g for Hib PRP-TT-Conjugation process. 21.01.2015
F. No. 12-53/SIIL / PAC-Hib / 14-BD,
Level-III
13. To include test for formaldehyde estimation on purified polysaccharide (PRP) of Haemophilus influenzae type b. Typographical correction in Hib fermentation BMR in the section of BOM. Typographical correction in primary recovery BMR in the section of BOM. Sterility test of Hib conjugate bulk will be put up by direct inoculation instead of membrane filtration method. Revision of BMRs for inoculum stages (S1, S2, S3), fermentation stage (S4) for Hib fermentors.
13.01.2010
Acknowledgement No 1618
Level-III
14. Tightening of in house specification for Total PRP content as NLT 0.25 mg/ml and total protein content as NLT 0.46 mg/ml for Hib bulk conjugate. 20.03.2012
F. No. 04-138 / 04-DC / (PAC-SCP-HIB) 11-BD
Level-III
15. To start fermentation and purification of Hib Polysaccharide in PCV facility, building no. SEZ-3 at same scale as in existing PCV facility in building no. SEZ-1B.
04.04.2012
F. No. 04-138 / 04-DC/ (PAC-Facility-Hib Type B) / 11-BD
Level-III
16. Transfer of ultra filtration system from DSP II area to DSP I area, incorporation of tank for use in conjugation activity from purification area used in the production of Hib type b conjugate vaccine.
03.05.2012
F. No. 04-138 / 04-DC / (PAC-CEQP-HIB) / 11-BD
Level-III
17. Transfer of centrifuge and ultra filtration system form one to another room within the same facility. 15.05.2012F. No. 04-138 / 04-DC / (PAC-CEQP-HIB) / 11-BD
Level-III
18. Inclusion of ‘container / closure integrity test’ in finished product (filled in containers) specification. 27.01.2014
Acknowledgement No 3719
Level-III
19. Inclusion of ‘particulate matter (visual) test’ in finished product specification. 27.01.2014
Acknowledgement No 3720
Level-III
20. Tighten the storage temperature of Haemophilus influenza type b bulk conjugate (Drug substance) from +2 to 8°C to -70°C. 09.11.2015
F. No. 12-107 / SIIL / PAC-Hib Bulk (DS) / 15-BD
7 Diphtheria, Tetanus, Pertussis
(Whole Cell), Hepatitis B (rDNA) and Haemophilus
Type b Conjugate Vaccine
(Adsorbed) (Liquid)
Level I
1. Permission to use semi-synthetic media (meat free) for the production of Diptheria & Tetanus toxoids (bulk) which are active ingredients for our Tetanus and Diphtheria containing combination vaccine
04.12.2008
(NOC F.No: 4-SII-36/MF DTP/07-DC)
Level I
2. Application involving production of Pertussis (Whole Cell) Bulk vaccine using fermenter in addition to currently being used Shake Flask 24.06.2014
(NOC F.No: 12-18/SIII/PAC-Pertussis (bulk)/14-BD)
Level II
1. Application involving replacement of sterility testing procedure for pre filled syringe components for Diphtheria, Tetanus and Pertussis (whole cell), hepatitis B (rDNA) and Haemophilus type b conjugate vaccine (adsorbed)
05.12.2013
(NOC F.No: 12-93/SERUM/PAC-DTPHBHIB/13-BD)
Level II
2. Application for the approval of Level II Post approval change to reduce the vial height from 40 mm to 30 mm for DTPHBHib. 09.12.2015
(NOC F.No: 12-124/SIIL/PAC-DTPHBHIB/15-BD)
Level II
3. Application for cell concentration process by using tangential flow filtration system as an additional method to centrifugation for Pertussis (whole cell) bulk vaccine manufacturing
21.01.2014
(NOC F.No: 12-115/SII/PAC-Pertussis (bulk)/13-BD)
Level II
4. To use of Sartron Hydrosart cassettes for microfiltration as an additional source to the currently used Prostak filtration modules for clarification of Diptheria Broth
28.02.2014
(NOC F.No: 12-116/SII/PAC-Diptheria (Broth) /13-BD)
Level II
5. Change in the manufacturing process of Haemophilus influenza type B (PRP-TT) conjugate vaccine for the use of TT developed in meat free semi synthetic medium.
30.11.2010
NOC F. No. PAC/SII/HIB /1/ 10-BD
Level II
6. Replacement of heat inactivation step with formalin for fermentation of Haemophilus influenza type b bulk. 21.03.2011
F. No. PAC/SII/Hib /2/ 10-BD
Level-II
7. Increase in Hib Polysaccharide input from 74 g to 110 g for Hib PRP-TT-Conjugation process. 21.01.2015
F. No. 12-53/SIIL / PAC-Hib / 14-BD,
Level III
1. Intimation of Level III Annual Notifiable change of Estabilishment of release specifications for "% free PRP" as "not more than 13.0 % of total PRP content" in DTPHBHib (Pentavalent vaccine)
24.01.2013
(Acknowledgement No 3431)
Level-III
2. Relocation of heavy duty refrigerated centrifuge EQ ID DB 0 114 56 0 20 (make: Sorvall) from Diphtheria block located at Building No 6 First Floor (FF) to Toxoid purification facility located at Building no 7, Ground floor (GF) The relocated centrifuge is identical to the centrifuge in use for manufacturing of purified Tetanus toxoid.
24.01.2013
(Acknowledged vide letter no. 3432)
Level-III
3. Intimation of Level III Annual Notifiable change of Incorporation of corrosion resistance test in the specification of sterile disposable needle of prefilled syringe which is supplied along with product Diphtheria, Tetanus, Pertussis (Whole cell) Hepatitis B (rDNA) and Haemophilus type B conjugate vaccine (Adsorbed) I.P.
24.01.2013
(Acknowledged vide letter no. 3433)
Level-III
4. To discontinue the in-process testing for microbial contamination detection (MCDT) on the dispensed antigens (Diptheria and Tetanus Toxoids) and presevative (2 % thiomersal solution) for (Diptheria, Tetanus and Pertussis (whole cell), Hepatitis B and Haemophilus influenzae type b conjugate vaccine (Adsorbed) I.P.)
27.01.2014
(Acknowledgement No 3721)
Level-III
5. Intimation of Level III change for Revival of one working seed tube (WSL) of each B-Pertussis strain Nos. 134, 509, 6229, 25525 and used for the preparation of one mixing vessel pool (MVP) of each facility instead of used for preparation of one lot fo each facility
27.01.2014
(Acknowledgement No 3724)
Level-III
6. Inclusion of "Container / closure integrity" test in the finished product specification for (Diptheria, Tetanus and Pertussis (whole cell), Hepatitis B and Haemophilus influenzae type b conjugate vaccine (Adsorbed) I.P.)
28.01.2014
(Acknowledgement No 3938)
Level-III
7. To reduce the concentration of thiomersal in purified tetanus Toxoidfrom 0.001 % to 0.005 % 28.01.2014
(Acknowledgement No 3945 )
Level-III
8. To reduce the concentration of thiomersal in purified Diptheria Toxoid from 0.001 % to 0.005 % 28.01.2014
(Acknowledgement No 3946 )
Level-III
9.Inclusion of "Particulate matter (visual) test in the finished product specification" for (Diptheria, Tetanus and Pertussis (whole cell), Hepatitis B and Haemophilus influenzae type b conjugate vaccine (Adsorbed) I.P.)
28.01.2014
(Acknowledgement No 3947)
Level-III
10. Elimination of pooling process from manufacturing of purified Toxoid. Identifying of existing "Purified Tetanus Toxoid Lot" as "Purified Tetanus Toxoid" which Is directly used for drug product manufacturing
8.01.2015
(Acknowledgement No 741)
Level-III
11. To pool and centrifugation of the harvested production flasks in four sublots instead of three sub lots for Pertussis bulk vaccine.
8.01.2015
(Acknowledgement No 743)
Level-III
12. To remove the step of checking specific gravity of bulk liquid every day before filling for Diphtheria, Tetanus, Pertussis (Whole Cell), Hepatitis B (rDNA) and Hacrnophilus Type b Conjugate Vaccine (Adsorbed) J.P.
08.01.2015
(Acknowledgement No 734)
Level-III
13. To replace the existing fermentors(New Brunswick Scientific) with the Bioengineering fermentors in Hepatitis B Bulk manufacturing facility Building No 6, First Floor
8.01.2015
(Acknowledgement No 738)
Level-III
14. To incorporate the following in T-ELISA procedure for potency estimation of Tetanus component: I) Test sample validity criteria. 2) Comparability of each new conjugate lot is demonstrated by performing two independent assays using old and new conjugate lots. 3) To prepare and run positive control in each test to establish the assay validity. for Diphtheria, Tetanus, Pertussis and Hepatitis B Vaccine
13.01.2016
(Acknowledgement No 1309)
Level-III
15. To remove the step of checking specific gravity of bulk liquid every day before filling for Diphtheria, Tetanus, Pertussis (Whole Cell),Hepatitis B (rONA) and Hacrnophilus Type b Conjugate Vaccine (Adsorbed) J.P.
11.01.2017
(Acknowledgement No 924)
Level-III
16. Intimation of Level III annual notifiable change of Installation of new Deep-Freezer (make kaltis, capacity 390L) in pertussis vaccine department
12.01.2017
Building No 6 Ground Floor Storage of Master and Working cultures of Bordetella pertussis in deep freezer at ≤ -20 degree instead of + 2 to 8 degree centigrade.(Acknowledgement No 1044)
Level-III
17. To include test for formaldehyde estimation on purified polysaccharide (PRP) of Haemophilus influenzae type b. Typographical correction in Hib fermentation BMR in the section of BOM. Typographical correction in primary recovery BMR in the section of BOM. Sterility test of Hib conjugate bulk will be put up by direct inoculation instead of membrane filtration method. Revision of BMRs for inoculum stages (S1, S2, S3), fermentation stage (S4) for Hib fermentors.
13.01.2010
Acknowledgement No 1618
Level-III
18. Tightening of in house specification for Total PRP content as NLT 0.25 mg/ml and total protein content as NLT 0.46 mg/ml for Hib bulk conjugate. 20.03.2012
F. No. 04-138 / 04-DC / (PAC-SCP-HIB) 11-BD
Level-III
19. To start fermentation and purification of Hib Polysaccharide in PCV facility, building no. SEZ-3 at same scale as in existing PCV facility in building no. SEZ-1B.
04.04.2012
F. No. 04-138 / 04-DC/ (PAC-Facility-Hib Type B) / 11-BD
Level-III
20. Transfer of ultra filtration system from DSP II area to DSP I area, incorporation of tank for use in conjugation activity from purification area used in the production of Hib type b conjugate vaccine.
03.05.2012
F. No. 04-138 / 04-DC / (PAC-CEQP-HIB) / 11-BD
Level-III
21. Transfer of centrifuge and ultra filtration system form one to another room within the same facility. 15.05.2012F. No. 04-138 / 04-DC / (PAC-CEQP-HIB) / 11-BD
Level-III22. Tighten the storage temperature of Haemophilus influenza type b bulk
09.11.2015
conjugate (Drug substance) from +2 to 8°C to -70°C.
F. No. 12-107 / SIIL / PAC-Hib Bulk (DS) / 15-BD
8 Diphtheria, Tetanus, Pertussis
(Whole Cell) and
Haemophilus Type b
Conjugate Vaccine
(Adsorbed) (Liquid)
Level I
1. Permission to use semi-synthetic media (meat free) for the production of Diptheria & Tetanus toxoids (bulk) which are active ingredients for our Tetanus and Diphtheria containing combination vaccine
04.12.2008
(NOC F.No: 4-SII-36/MF DTP/07-DC)
Level I
2. Application involving production of Pertussis (Whole Cell) Bulk vaccine using fermenter in addition to currently being used Shake Flask 24.06.2014
(NOC F.No: 12-18/SIII/PAC-Pertussis (bulk)/14-BD)
Level II
1. Application for cell concentration process by using tangential flow filtration system as an additional method to centrifugation for Pertussis (whole cell) bulk vaccine manufacturing
21.01.2014
(NOC F.No: 12-115/SII/PAC-Pertussis (bulk)/13-BD)
Level II
2. To use of Sartron Hydrosart cassettes for microfiltration as an additional source to the currently used Prostak filtration modules for clarification of Diptheria Broth
28.02.2014
(NOC F.No: 12-116/SII/PAC-Diptheria (Broth) /13-BD)
Level II
3. Change in the manufacturing process of Haemophilus influenza type B (PRP-TT) conjugate vaccine for the use of TT developed in meat free semi synthetic medium.
30.11.2010
NOC F. No. PAC/SII/HIB /1/ 10-BD
Level II
4. Replacement of heat inactivation step with formalin for fermentation of Haemophilus influenza type b bulk. 21.03.2011
F. No. PAC/SII/Hib /2/ 10-BD
Level-II
5. Increase in Hib Polysaccharide input from 74 g to 110 g for Hib PRP-TT-Conjugation process. 21.01.2015
F. No. 12-53/SIIL / PAC-Hib / 14-BD,
Level-III
1. Relocation of heavy duty refrigerated centrifuge EQ ID DB 0 114 56 0 20 (make: Sorvall) from Diphtheria block located at Building No 6 First Floor (FF) to Toxoid purification facility located at Building no 7, Ground floor (GF) The relocated centrifuge is identical to the centrifuge in use for manufacturing of purified Tetanus toxoid.
24.01.2013
(Acknowledged vide letter no. 3432)
Level-III
2. Intimation of Level III change for Revival of one working seed tube (WSL) of each B-Pertussis strain Nos. 134, 509, 6229, 25525 and used for the preparation of one mixing vessel pool (MVP) of each facility instead of used for preparation of one lot fo each facility
27.01.2014
(Acknowledgement No 3724)
Level-III
3. To discontinue the in-process testing for microbial contamination detection (MCDT) on the dispensed antigens (Diptheria and Tetanus Toxoids) and presevative (2 % thiomersal solution) for (Diptheria, Tetanus and Pertussis (whole cell) and Haemophilus influenzae type b conjugate vaccine (Adsorbed) I.P.)
28.01.2014
(Acknowledgement No 3942)
Level-III
4. To reduce the concentration of thiomersal in purified tetanus Toxoid from 0.001 % to 0.005 % 28.01.2014
(Acknowledgement No 3945 )
Level-III
5. To reduce the concentration of thiomersal in purified Diptheria Toxoid from 0.001 % to 0.005 % 28.01.2014
(Acknowledgement No 3946 )
Level-III
6. Inclusion of "Particulate matter (visual) test in the finished product specification" for (Diptheria and Tetanus and Pertussis and Haemophilus Type b conjugatevaccine (adsorbed) I.P.
28.01.2014
(Acknowledgement No 3949)
Level-III
7. Inclusion of "Container / closure integrity" test in the finished product specification for (Diptheria, Tetanus and Pertussis (whole cell) and Haemophilus influenzae type b conjugate vaccine (Adsorbed) I.P.)
29.01.2014
(Acknowledgement No 4152)
Level-III
8. To replace the existing fermentors (New Brunswick Scientific) with the Bioengineering fermentors in Hepatitis B Bulk manufacturing facility Building No 6, First Floor
08.01.2015
(Acknowledgement No 738)
Level-III
9. To pool and centrifugation of the harvested production flasks in four sublots instead of three sub lots for Pertussis bulk vaccine
08.01.2015
(Acknowledgement No 743)
Level-III
10. Elimination of pooling process from manufacturing of purified Toxoid. Identifying of existing "Purified Tetanus Toxoid Lot" as "Purified Tetanus Toxoid" which Is directly used for drug product manufacturing
08.01.2015
(Acknowledgement No 741)
Level-III
11. To incorporate the following in T-ELISA procedure for potency estimation of Tetanus component: I) Test sample validity criteria. 2) Comparability of each new conjugate lot is demonstrated by performing two independent assays using old and new conjugate lots. 3) To prepare and run positive control in each test to establish the assay validity. for Diphtheria, Tetanus, Pertussis and Haemophilus influenzae type b conjugate Vaccine Adsorbed
13.01.2016
(Acknowledgement No 1176)
Level-III
12. Installation of new Deep-Freezer (Make:Kaltis, Capacity: 390 L) in pertussis vaccine department, Building No 6, Ground floor. Storage of Master and working cultures of Bordetel!a pertussis in deep freezer at - 20 °C instead of +2 to 8 °C
12.01.2017
(Acknowledgement No 1044)
Level-III
13. To remove the step of checking specific gravity of bulk liquid every day before filling for Diphtheria, Tetanus, Pertussis (Whole Cell), and Hacrnophilus Type b Conjugate Vaccine (Adsorbed) I.P.
12.01.2017
(Acknowledgement No 1058)
Level-III
14. To include test for formaldehyde estimation on purified polysaccharide (PRP) of Haemophilus influenzae type b. Typographical correction in Hib fermentation BMR in the section of BOM. Typographical correction in primary recovery BMR in the section of BOM. Sterility test of Hib conjugate bulk will be put up by direct inoculation instead of membrane filtration method. Revision of BMRs for inoculum stages (S1, S2, S3), fermentation stage (S4) for Hib fermentors.
21.01.2010
Acknowledgement No 1618
Level-III
15. Tightening of in house specification for Total PRP content as NLT 0.25 mg/ml and total protein content as NLT 0.46 mg/ml for Hib bulk conjugate. 20.03.2012
F. No. 04-138 / 04-DC / (PAC-SCP-HIB) 11-BD
Level-III
16. To start fermentation and purification of Hib Polysaccharide in PCV facility, building no. SEZ-3 at same scale as in existing PCV facility in building no. SEZ-1B.
04.04.2012
F. No. 04-138 / 04-DC/ (PAC-Facility-Hib Type B) / 11-BD
Level-III
17. Transfer of ultra filtration system from DSP II area to DSP I area, incorporation of tank for use in conjugation activity from purification area used in the production of Hib type b conjugate vaccine.
03.05.2012
F. No. 04-138 / 04-DC / (PAC-CEQP-HIB) / 11-BD
Level-III
18. Transfer of centrifuge and ultra filtration system form one to another room within the same facility. 15.05.2012F. No. 04-138 / 04-DC / (PAC-CEQP-HIB) / 11-BD
Level-III
19. Tighten the storage temperature of Haemophilus influenza type b bulk conjugate (Drug substance) from +2 to 8°C to -70°C. 09.11.2015
F. No. 12-107 / SIIL / PAC-Hib Bulk (DS) / 15-BD
9Hepatitis B
Vaccine Level-II
Application to reduce the vial height from 40 mm to 30 mm for Hepatitis B vaccine
09.12.2016
(rDNA) (Adult) (rDNA), Adult 1 dose and Hepatitis B vaccine (rDNA), Paediatric 1 dose. (NOC F.No: 12-147/Serum/PAC-Hep.B/16-BD)
Level-III
To remove the step of checking specific gravity of bulk liquid every day before filling. For Hepatitis B (Aqueous) Bulk. 08.01.2015
(Acknowledgement No 735)
Level-III
To replace the existing fermentors (New Brunswick Scientific) with the Bioengineering fermentors in Hepatitis B Bulk manufacturing facility Building No 6, First Floor
08.01.2015
(Acknowledgement No 738)
Level-III
Inclusion of "Particulate Matter (Visual)" test in the finished product specification for (Hepatitis B vaccine (r-DNA) 22.01.2014
(Acknowledgement No 3013)
Level-III
Inclusion of "Container / closure integrity" test in the finished product specification for (Hepatitis B vaccine (r-DNA)
22.01.2014
(Acknowledgement No 3015)
Level-III
To start using OPC (One Point Cut) ampoules, in place of existing 'Snap-Off' ampoules for Hepatitis B vaccine (rDNA) filled in ampoules.
12.01.2017
(Acknowledgement No 1054)
10
Hepatitis B Vaccine (rDNA)
(Paediatric)
Level-II
Application to reduce the vial height from 40 mm to 30 mm for Hepatitis B vaccine (rDNA), Adult 1 dose and Hepatitis B vaccine (rDNA), Paediatric 1 dose. 09.12.2016
(NOC F.No: 12-147/Serum/PAC-Hep.B/16-BD)
Level-III
To remove the step of checking specific gravity of bulk liquid every day before filling. For Hepatitis B (Aqueous) Bulk. 08.01.2015
(Acknowledgement No 735)
Level-III
To replace the existing fermentors (New Brunswick Scientific) with the Bioengineering fermentors in Hepatitis B Bulk manufacturing facility Building No 6, First Floor
08.01.2015
(Acknowledgement No 738)
Level-III
Inclusion of "Container / closure integrity" test in the finished product specification for (Hepatitis B vaccine (r-DNA))
22.01.2014
(Acknowledgement No 3012)
Level-III
Inclusion of "Particulate Matter (Visual)" test in the finished product specification for (Hepatitis B vaccine (r-DNA) 22.01.2014
(Acknowledgement No 3014)
Level-III
To start using OPC (One Point Cut) ampoules, in place of existing 'Snap-Off' ampoules for Hepatitis B vaccine (rDNA) filled in ampoules.
12.01.2017
(Acknowledgement No 1054)11 Haemophilus
Influenza Type b (Hib)
Conjugate Vaccine
Level-II
1. Change in the manufacturing process of Haemophilus influenza type B (PRP-TT) conjugate vaccine for the use of TT developed in meat free semi synthetic medium.
F. No. PAC/SII/HIB /1/ 10-BD, dt. 30th Nov. 2010
Level-II2. Replacement of heat inactivation step with formalin for fermentation of Haemophilus influenza type b bulk.
F. No. PAC/SII/Hib /2/ 10-BD, dt. 21st Mar. 2011
Level-II3. Change in the composition of container closure system for Haemophilus influenza type B conjugate vaccine.
F. No. 04-138 / 04-DC /(PAC-CCS-HIB) / 11-
BD, dt. 21st Sep. 2011
Level-II
4. Amendment in ‘condition no. 2’ of the permission granted for ‘change in the composition of container closure system for Haemophilus influenza type B conjugate vaccine.
F. No. 04-138 / 04-DC /(PAC-CCS-HIB) / 11-
BD, dt. 25th Nov. 2011
Level-II
5. Introduction of M/s. Aptar Stelmi as an additional supplier for stoppers made with similar formulation as bromobutyl 6740GS to the existing supplier i.e. M/s. Datwyler (Helvoet) supplying stoppers with formulation as bromobutyl FM 460.
F. No. 12-120 / SIIPL/ PAC/ PAC-
Meningococcal /16-BD, dt. 19th Jul. 2016
Level-II
6. Amendment in ‘file no.’ of the permission granted for ‘Introduction of M/s. Aptar Stelmi as an additional supplier for stoppers made with similar formulation as bromobutyl 6740GS to the existing supplier i.e. M/s. Datwyler (Helvoet) supplying stoppers with formulation as bromobutyl FM 460’.
F. No. 12-53/SIIL/ PAC-Hib / 16-BD,
dt. 20th Oct. 2016
Level-II7. Increase in Hib Polysaccharide input from 74 g to 110 g for Hib PRP-TT-Conjugation process.
F. No. 12-53/SIIL / PAC-Hib / 14-BD, dt.
21st Jan 2015
Level-III
1. To include test for formaldehyde estimation on purified polysaccharide (PRP) of Haemophilus influenzae type b.
1618, dt. 7th Jan. 2010
Typographical correction in Hib
fermentation BMR in the section of BOM.Typographical correction in primary recovery BMR in the section of BOM.Sterility test of Hib conjugate bulk will be put up by direct inoculation instead of membrane filtration method.Revision of BMRs for inoculum stages (S1, S2, S3), fermentation stage (S4) for Hib fermentors.
Level-III
2. Tightening of in house specification for Total PRP content as NLT 0.25 mg/ml and total protein content as NLT 0.46 mg/ml for Hib bulk conjugate.
F. No. 04-138 / 04-DC / (PAC-SCP-HIB) 11-BD, 20th Mar. 2012.
Level-III
3. To start fermentation and purification of Hib Polysaccharide in PCV facility, building no. SEZ-3 at same scale as in existing PCV facility in building no. SEZ-1B.
F. No. 04-138 / 04-DC/ (PAC-Facility-Hib Type B) / 11-BD, 4th
Apr. 2012
Level-III
4. Transfer of ultra filtration system from DSP II area to DSP I area, incorporation of tank for use in conjugation activity from purification area used in the production of Hib type b conjugate vaccine.
F. No. 04-138 / 04-DC / (PAC-CEQP-HIB) / 11-BD, dt. 3rd May
2012
Level-III5. Transfer of centrifuge and ultra filtration system form one to another room within the same facility.
F. No. 04-138 / 04-DC / (PAC-CEQP-HIB) /
11-BD, dt. 15th May 2012
Level-III6. Inclusion of ‘container / closure integrity test’ in finished product (filled in containers) specification.
3719, dt. 27th Jan. 2014
Level-III7. Inclusion of ‘particulate matter (visual) test’ in finished product specification.
3720, dt. 27th Jan. 2014
Level-III
8. Tighten the storage temperature of Haemophilus influenza type b bulk conjugate (Drug substance) from +2 to 8°C to -70°C.
F. No. 12-107 / SIIL / PAC-Hib Bulk (DS) /
15-BD, 9th Nov. 2015
12Poliomyelitis
Vaccine (Inactivated)
Level II Modification in container closure
system from vial to PFS 1-Dec-10
Level II
To manufacture poliomyelitis vaccine (Inactivated) in multi dose packaging
i.e. 2 and 5 dose vial in addition to existing licensed single dose vaccine
15-Oct-14
Level IIReplacement of sterility testing
procedure from direct inoculation to membrane filtration method
15-Oct-13
Level II Change in reference standard for
inactivated poliomyelitis virus 20-Mar-12
Level III Inclusion of container closure integrity
test in the finished product specification
17-Jan-14
Level III Packing of IPV in PFS 17-Jan-14
Level III Inclusion of particluate matter (Visual)
tests in the finished product specification
17-Jan-14
Level III Change to an approved analytical procedure used to estimation of
formaldehyde content in IPV 17-Mar-15
Level III Addition of sodium alginate and
miniscus tests to check the siliconization of internal surface of vials
12-Jan-17
Level III Removal of efficacy test (in vivo assay)
from the final bulk specification pf poliomyelitis vaccine
1/12/2017
13 Measles Vaccine (live)
IP
TO INTRODUCE NEW SPECIFICATIONS OF MINIMUM POTENCY FOR MEASLES, MUMPS AND RUBELLA COMPONENTS OF MMR GROUP OF VACCINE. MEASLES POTENCY: 3.5 LOG10 CCID50/0.5 ML, MUMPS POTENCY: 4.200 LOG10 CCID50 / 0.5 ML. RUBELLA POTENCY: 3.400 LOG10 CCID50 / 0.5 ML.
NOC/ Acknowledgement
DCG(I): Acknowledgment
vide letter SSJ/PAC/2011
Level IITo extend the shelf life of Measles
clarified virus pool (CVP) from 4 years to 6 years.
F. No. 12-104/SERUM/(PAC-
Measles)/ 13-BD
Level II
To introduce Stelmi stoppers as a second supplier for MMR group of vaccine. The stopper compound selected is a bromobutyl low moisture compound 6740. The stopper drawing reference is C1818.
F. No. 12-126/SIIL/PAC-MMR/ 15-BD
Level III
To introduce the method of one step rverse transcriptase polymer chain reaction (RT-PCR) and to prepare common MTRs for all the tests used in the identity testing of labelled containers of measles, mumps, rubella, MR and MMR vaccines.
F. No. 04-219/05-DC/(PAC-SPE-MMR)/ll-BD
Level III
Change in monitoring classification of room no. 34 (PAL -4), 35 ( MAL), 44 (MAL), 07 (PAL-4), 80 (PAL-4), 71 (MAL), 64 (PAL-4) of building no 9 first floor measles cell culture, virus culture,
1618
Rubella, Mumps and thawing area from grade-C to grade-B.
Level IIIChange in reference of summary protocol from IP 96 to IP 2007 in final bulk certification in MMR group of vaccine
1618
Level III
1) To discontinue manufacturing of Influenza vaccine in Bld. 3 GF. 2) To reinitiate the manufacturing of MMR group vaccines in Bld. 3 GF.
F. No. 12-63/SERUM/09-
BD/(PAC-Storage-HlNl)/ 11-BD
Level III
Inclusion of "Particulate Matter (Visual)" test in all the finished products manufactured and marketed by Serum Institute of India Ltd.
3007
Level III
Inclusion of "Container/Closure integirty" test in all the finished products (Filled in containers Manufactured by Serum Institute of India Ltd)
3008
Level III
It is proposed to use Lactalbumin Hydrolyzate (LAH) from the newly approved vendors (Oxide & Hyclone) for commercial scale manufacturing of MMR bulks. Refer. (CH14/426)
925
Level IIIExtension of shelf life for MMR group of vaccines from 24 months to 30 months.
36728
14 Meningococcal Conjugate vaccine,
Lyophilized Level II
Rubber stopper of PCV group of vaccines (Hib and Men A) are presently made up of Bromo - butyl rubber compound FM 257 / 6213. It is proposed to change this compound to FM 460
NOC/ Acknowledgement
F. No. 12-1/Serum/09-
BD/(PAC-MED-MEN)/11-BD
Level II
To increase shelf life of Meningococcal A conjugate vaccine lyophilized from assigned shelf life of 2 years to 3 years. The consistency lots of Meningococcal A conjugate vaccine manufactured using SIIL's polysaccharide have completed 3 years stability time point for batch No. 127M8001, 127M8002 and 127M8003 and the results demonstrate that all specification are complied at with 36 months (2-8°C) time point. Currently Meningococcal A conjugate vaccine having shelf life of 2 years and with the current available data, we propose shelf life from 2 years to 3 years.
F. No. 12·1/SERUM/09-BD
Level IITo initiate the manufacturing of one lot of Men A bulk conjugate using semi
F. No. PAC/Sll/HIB/1/10-
synthetic TT (Meat Free) at 100 g scale. BD
Level IITo revise the shelf life of Diluent for Meningococcal A conjugate vaccine fromk 42 months to 60 monhs
F. No. 12-71/Serum/PAC-Meningococcal Vaccine/15-BD
Level II
To introduce 13 mm Lyo stoppers amde by 'Stelmi' ( code : 90000508/20012821 ) in the products of Hib and Men A. The stopper is the low moisture Bromobutyl copmound designated 6740. Existing Procedure : Stoppers used in Hib and Men A are from vendor 'Datwyler' ( code : 20007530) low moisture Bromobutyl compound FM460.
DCG(I) Approval: F.No.12-
120/SIIPL/PAC-Meningococcal/16-BD and F.No.12-120/SIIPL/PAC-
Meningococcal/16-BD with amendment
in company name
Level II
To revise the label storage condition of Diluent for Meningococcal A conjugate vaccine. " Store below +25ºC; do not freeze" to " do not freeze".
F. No. 12-11/Serum/PAC-
Meningococal/ 16-BD
Level III
To revise the specification of saccharideto protein ratio (conjugation marker) for Men A purified bulk conjugate from 0.30 - 1.00 to 0.30 - 0.80
F. No. 12-27 /SERUM/(PAC-Men.A) / 13-BD
Level III
Specification limit of unbound (free) saccharide for Meningicoccal A purified bulk conjugate is 15 % as an inhouse release anf 30 % for stability. We intend to revise the specification limit of unbound (free) saccharide meningococcal A purified bulk conjugate to 15 % for release as well as stability.
F. No. 12-27 /SERUM/(PAC-Men.A)/13-BD
Level IIITo include three washes of UF membrane using HEPES-EDTA buffer for optimum recovery of activated polysaccharide.
F. No. 12-27 /SERUM/(PAC-Men.A) / 13-BD
Level IIITo assign specification for residual Iodine in Men A purified Bulk conjugate at "Not more than 16.40mg/ml.
F. No. 12-27 /SERUM/(PAC-Men.A) / 13-BD
Level III
To add testing of residual Sodium borohydride in Men-A purified bulk conjugate samples with the specification of "Not more than 17.5 PPM.
F. No. 12-27 /SERUM/(PAC-Men.A) / 13-BD
Level IIITo include internal standard for phosphorous assay in Men A conjugate bulk
2269
Level IIITo include internal standard for phosphorous assay in Men A conjugate
3010
vaccine
Level III
To increase the incubation temperature from 37° C to 90 and decrease the incubation time to approximately 3 minutes in phosphorous assay for Meningococcal A conjugate bulk
2272
Level III
To increase the incubation temperature from 37° C to 90 and decrease the incubation time to approximately 3 minutes in phosphorous assay for Meningococcal A conjugate bulk
2279
Level IIIInclusion of particulate matter (visual) tests in the finished product specification
2268
Level IIIInclusion of container/ closure intergrity test in the finished product (filled in containers) specification
2275
15 Measles, Mumps and
Rubella Vaccine (live)
IP
TO INTRODUCE NEW SPECIFICATIONS OF MINIMUM POTENCY FOR MEASLES, MUMPS AND RUBELLA COMPONENTS OF MMR GROUP OF VACCINE. MEASLES POTENCY: 3.5 LOG10 CCID50/0.5 ML, MUMPS POTENCY: 4.200 LOG10 CCID50 / 0.5 ML. RUBELLA POTENCY: 3.400 LOG10 CCID50 / 0.5 ML.
NOC/ Acknowledgement
DCG(I): Acknowledgment
vide letter SSJ/PAC/2011
Level III
Change in monitoring classification of room no. 34 (PAL -4), 35 ( MAL), 44 (MAL), 07 (PAL-4), 80 (PAL-4), 71 (MAL), 64 (PAL-4) of building no 9 first floor measles cell culture, virus culture, Rubella, Mumps and thawing area from grade-C to grade-B.
1618
Level IIIChange in reference of summary protocol
from IP 96 to IP 2007 in final bulk certification in MMR group of vaccine
1618
Level II
Rubber stoppers used for BCG vaccine & MMR filling are presently made up of bromobutyl rubber compound (FM 257/6213). It is proposed to change this compound FM 460
F. No. 12-84/Serum/ 10-BD
Level III
To introduce the method of one step rverse transcriptase polymer chain reaction (RT-PCR) and to prepare common MTRs for all the tests used in the identity testing of labelled containers of measles, mumps, rubella, MR and MMR vaccines.
F. No. 04-219/05-DC/(PAC-SPE-MMR)/ll-BD
Level III
1) To discontinue manufacturing of Influenza vaccine in Bld. 3 GF. 2) To reinitiate the manufacturing of MMR group vaccines in Bld. 3 GF.
F. No. 12-63/SERUM/09-
BD/(PAC-Storage-HlNl)/ 11-BD
Level III
To convert Rubella / Mumps bulk vaccine production facility in SEZ - 1B first floor in to Measles / Mumps / Rubella bulk vaccine production facility.
F. No. PAC/Sll/HIB/1/10-
BD
Level III
Inclusion of "Particulate Matter (Visual)" test in all the finished products manufactured and marketed by Serum Institute of India Ltd.
3016
Level III
Inclusion of "Container/Closure integirty" test in all the finished products (Filled in containers Manufactured by Serum Institute of India Ltd)
3003
Level II
To perform the "Test for Mycoplasma by PCR ELISA method" only at the concluding time points of real time and accelerated stability study of MMR group of vaccines
F. No. 12-120/ SIII/PAC-MMR /13-
BD
Level II
To introduce Stelmi stoppers as a second supplier for MMR group of vaccine. The stopper compound selected is a bromobutyl low moisture compound 6740. The stopper drawing reference is C1818.
F. No. 12-126/SIIL/PAC-MMR/ 15-BD
Level III
It is proposed to use Lactalbumin Hydrolyzate (LAH) from the newly approved vendors (Oxide & Hyclone) for commercial scale manufacturing of MMR bulks. Refer. (CH14/426)
923
Level III Extension of shelf life for MMR group of vaccines from 24 months to 30 months.
36730
16 Measles and Rubella
Vaccine (live) IP
TO INTRODUCE NEW SPECIFICATIONS OF MINIMUM POTENCY FOR MEASLES, MUMPS AND RUBELLA COMPONENTS OF MMR GROUP OF VACCINE. MEASLES POTENCY: 3.5 LOG10 CCID50/0.5 ML, MUMPS POTENCY: 4.200 LOG10 CCID50 / 0.5 ML. RUBELLA POTENCY: 3.400 LOG10 CCID50 / 0.5 ML.
NOC/ Acknowledgement
DCG(I): Acknowledgment
vide letter SSJ/PAC/2011
Level III
Change in monitoring classification of room no. 34 (PAL -4), 35 ( MAL), 44 (MAL), 07 (PAL-4), 80 (PAL-4), 71 (MAL), 64 (PAL-4) of building no 9 first floor measles cell culture, virus culture,
1618
Rubella, Mumps and thawing area from grade-C to grade-B.
Level IIIChange in reference of summary protocol
from IP 96 to IP 2007 in final bulk certification in MMR group of vaccine
1618
Level III
To introduce the method of one step rverse transcriptase polymer chain reaction (RT-PCR) and to prepare common MTRs for all the tests used in the identity testing of labelled containers of measles, mumps, rubella, MR and MMR vaccines.
F. No. 04-219/05-DC/(PAC-SPE-MMR)/ll-BD
Level III
1) To discontinue manufacturing of Influenza vaccine in Bld. 3 GF. 2) To reinitiate the manufacturing of MMR group vaccines in Bld. 3 GF.
F. No. 12-63/SERUM/09-
BD/(PAC-Storage-HlNl)/ 11-BD
Level III
Inclusion of "Particulate Matter (Visual)" test in all the finished products manufactured and marketed by Serum Institute of India Ltd.
3005
Level III
Inclusion of "Container/Closure integirty" test in all the finished products (Filled in containers Manufactured by Serum Institute of India Ltd)
3006
Level II
To introduce Stelmi stoppers as a second supplier for MMR group of vaccine. The stopper compound selected is a bromobutyl low moisture compound 6740. The stopper drawing reference is C1818.
F. No. 12-126/SIIL/PAC-MMR/ 15-BD
Level III
It is proposed to use Lactalbumin Hydrolyzate (LAH) from the newly approved vendors (Oxide & Hyclone) for commercial scale manufacturing of MMR bulks. Refer. (CH14/426)
921
Level III Extension of shelf life for MMR group of vaccines from 24 months to 30 months.
36727
17
Influenza Vaccine
(Human, Live Attenuated), {Pandemic
(H1N1) freeze dried Vaccine}
Level IIIAdditional quality control laboratory at
Influenza Block; First floor for analytical activities of Influenza vaccine
17-Mar-15
Level III
Inclusion of container closure integrity test in the final product specification for the Influenza vaccine, Pandemic
H1N1 vaccine
17-Mar-15
Level IIIInclusion of particluate matter test in the final product specification for the
Influenza vaccine, Pandemic H1N1 17-Mar-15
vaccine
18 Rubella Vaccine (live)
IP
TO INTRODUCE NEW SPECIFICATIONS OF MINIMUM POTENCY FOR MEASLES, MUMPS AND RUBELLA COMPONENTS OF MMR GROUP OF VACCINE. MEASLES POTENCY: 3.5 LOG10 CCID50/0.5 ML, MUMPS POTENCY: 4.200 LOG10 CCID50 / 0.5 ML. RUBELLA POTENCY: 3.400 LOG10 CCID50 / 0.5 ML.
NOC/ Acknowledgement
DCG(I): Acknowledgment
vide letter SSJ/PAC/2011
Level III
Change in monitoring classification of room no. 34 (PAL -4), 35 ( MAL), 44 (MAL), 07 (PAL-4), 80 (PAL-4), 71 (MAL), 64 (PAL-4) of building no 9 first floor measles cell culture, virus culture, Rubella, Mumps and thawing area from grade-C to grade-B.
1618
Level IIIChange in reference of summary protocol
from IP 96 to IP 2007 in final bulk certification in MMR group of vaccine
1618
Level III
To introduce the method of one step rverse transcriptase polymer chain reaction (RT-PCR) and to prepare common MTRs for all the tests used in the identity testing of labelled containers of measles, mumps, rubella, MR and MMR vaccines.
F. No. 04-219/05-DC/(PAC-SPE-MMR)/ll-BD
Level III
1) To discontinue manufacturing of Influenza vaccine in Bld. 3 GF. 2) To reinitiate the manufacturing of MMR group vaccines in Bld. 3 GF.
F. No. 12-63/SERUM/09-
BD/(PAC-Storage-HlNl)/ 11-BD
Level IITo extend the shelf life of Rubella CVP from 4 years to 5 years
F. No. 12-43/SERUM/(PAC-
Rubella(CVP)) / 13-BD
Level III
Inclusion of "Particulate Matter (Visual)" test in all the finished products manufactured and marketed by Serum Institute of India Ltd.
3004
Level IIIInclusion of "Container/Closure integirty" test in all the finished products (Filled in containers Manufactured by Serum
2581
Institute of India Ltd)
Level II To extend the shelf life of Rubella clarified virus pool (CVP) from 5 years to 6 years.
F. No. 12-103/SERUM/(PAC-
Rubella)/ 13-BD
Level II
To introduce Stelmi stoppers as a second supplier for MMR group of vaccine. The stopper compound selected is a bromobutyl low moisture compound 6740. The stopper drawing reference is C1818.
F. No. 12-126/SIIL/PAC-MMR/ 15-BD
Level III
It is proposed to use Lactalbumin Hydrolyzate (LAH) from the newly approved vendors (Oxide & Hyclone) for commercial scale manufacturing of MMR bulks. Refer. (CH14/426)
922
Level III Extension of shelf life for MMR group of vaccines from 24 months to 30 months.
36729
19
Influenza Vaccine, Live
attenuated (Human), seasonalTrivalent
freeze dtied
Level III
"starting an additional quality control laboratory at Influenza Block; firstfloor for analytical activities of Influenza Vaccines
17-03-2015
Level III"Inclusion of container/ closure integrity test in Finished Product (filled in containers) specification
17-03-2015
Level III
"Inclusion of particulate matter (Visual) tests in the finished product specification for the Influenza Vaccine, Live Attenuated (Human), seasonal Trivalent, Freeze Dried",
17-03-2015
Level III
"tightening the specification of bacterial Endotoxin test (BET) forInfluenza Vaccine, Live Attenuated (human),Seasonal Trivalent, Freeze Dried",
17-03-2015
Level III
"tightening the specification of Bacterial Endotoxin test (BET) andPhenotypic characterization test of clarified monovalentVirus pool (Drug substance)of Trivalent strains (A/HlNl, A/H3N2 and Type B)
17-03-2015
Level II
""Use ofspecific pathogen free (SPF) hen's eggs from additional vendor "M/s. Immunetic Lifesciences Private Ltd" for manufacturing of influenza Bulk vaccin e"
04-10-2016
Level IIIChange in the procedure of Adventious agent test to comply with I.P 13-01-2015
Level IIIRevision of SOP and MTR of Influenza vaccine (Human, live attenuated ) to include ALV test on control eggs
13-01-2015
Level IIINew addition of analytical by converting office area at building no.4 ground floor media preparation block
12-01-2015
Level III
Tightening the specification of BET from Not more than 180IU/Dose to Not more than 100IU/Dose for drug product
12-01-2017
Level IIITightening the specification of BET from Not more than 180IU/0.5ml to Not more than 100IU/0.5ml for CMVP
12-01-2017
Level III
"amendment of the existing product license from Influenza vaccine,Live attenuated (human), Seasonal, Trivalent, Freeze dried to Influenza Vaccine (Human, Live Attenuated) I.P. Seasonal, Trivalent, Freeze dried and to obtain"additional product license/permission for the diluent 'sterile water for inhalationIP'
22-09-2016
20
Diphtheria and Tetanus Vaccine
(Adsorbed) For Adult and
Adolescents
Level I
1. Permission to use semi-synthetic media (meat free) for the production of Diptheria & Tetanus toxoids (bulk) which are active ingredients for our Tetanus and Diphtheria containing combination vaccine
04.12.2008
(NOC F.No: 4-SII-36/MF DTP/07-DC)
Level II
1. To use of Sartron Hydrosart cassettes for microfiltration as an additional source to the currently used Prostak filtration modules for clarification of Diptheria Broth
28.02.2014
(NOC F.No: 12-116/SII/PAC-Diptheria (Broth) /13-BD)
Level III
1. Application for the reduction of injection Dose from 1.0 ml to 0.5 ml in guinea pigs for abnormal toxicity test of final lot for Diphtheria and Tetanus vaccine (Adsorbed) for adults and Adollescents
04.03.2013
(NOC F.No: 12-23/SERUM/PAC-DTP/13-BD)
Level III
2. To reduce the concentration of Thiomersal from 0.01 % to 0.005 % in Diptheria and Tetanus Vaccine (Adsorbed) for Adults and Adolescents I.P
03.02.2015
(NOC F.No: 12-107/SIIL/PAC-DT vaccine/14-BD)
Level-III
3. Relocation of heavy duty refrigerated centrifuge EQ ID DB 0 114 56 0 20 (make: Sorvall) from Diphtheria block located at Building No 6 First Floor (FF) to Toxoid purification facility located at Building no 7, Ground floor (GF) The relocated centrifuge is identical to the centrifuge in use for manufacturing of purified Tetanus toxoid.
24.01.2013
(Acknowledged vide letter no. 3432)
Level-III
4. To discontinue the in-process testing for microbial contamination detection (MCDT) on the dispensed antigens Diphtheria and Tetanus Toxoids and preservative (2 % Thiomersal Saline Solution).
27.01.2014
(Acknowledged vide letter no. 3714)
Level-III
5. Inclusion of "Particulate matter (Visual)" tests in the finished product specification. 27.01.2014
(Acknowledged vide letter no. 3716)
Level-III
6. Inclusion of "container / closure integrity" tests in the finished product (filled in containers) specification. 27.01.2014
(Acknowledged vide letter no. 4151)
Level-III
7. To reduce the concentration of thiomersal in purified Tetanus toxoid pool from 0.001 % to 0.005 % 28.01.2014
(Acknowledgement No 3945)
Level-III
8. To reduce the concentration of thiomersal in purified Diptheria Toxoid from 0.001 % to 0.005 % 28.01.2014
(Acknowledgement No 3946 )
Level-III
9. Elimination of pooling process from manufacturing of purified Toxoid. Identifying of existing "Purified Tetanus Toxoid Lot" as "Purified Tetanus Toxoid" which Is directly used for drug product manufacturing
08.01.2015
(Acknowledgement No 741)
Level-III
10. To remove the step of checking specific gravity of bulk liquid every day before filling for Diphtheria and Tetanus Vaccine Adsorbed for Adults and Adolescents
13.01.2016
(Acknowledgement No 1170)
Level-III
11. To incorporate the following in T-ELISA procedure for potency estimation of Tetanus component: I) Test sample validity criteria. 2) Comparability of each new conjugate lot is demonstrated by performing two independent assays using old and new conjugate lots. 3) To prepare and run positive control in each test to establish the assay validity. for Diphtheria and Tetanus Vaccine Adsorbed for Adults and Adolescents.
13.01.2016
(Acknowledgement No 1173)
Level-III
12. To start using OPC (One Point Cut) ampoules, in place of existing "Snap Off' ampoules, for Diptheria and Tetanus (Adsorbed) for Adults and Adolescents I.P.
11.01.2017
(Acknowledgement No 919)
21Tetanus Vaccine
(Adsorbed)
Level I
1. Permission to use semi-synthetic media (meat free) for the production of Diptheria & Tetanus toxoids (bulk) which are active ingredients for our Tetanus and Diphtheria containing combination vaccine
04.12.2008
(NOC F.No: 4-SII-36/MF DTP/07-DC)
Level-III
1. Relocation of heavy duty refrigerated centrifuge EQ ID DB 0 114 56 0 20 (make: Sorvall) from Diphtheria block located at Building No 6 First Floor (FF) to Toxoid purification facility located at Building no 7, Ground floor (GF) The relocated centrifuge is identical to the centrifuge in use for manufacturing of purified Tetanus toxoid.
24.01.2013
(Acknowledged vide letter no. 3432)
Level-III
2. Application for reduction of injection Dose from 1.0 ml to 0.5 ml in guinea pigs for abnormal toxicity test of final lot for Tetanus Vaccine (Adsorbed) 04.03.2013
(NOC F.No:12-24/SERUM/PAC-TETANUS / 13-DC)
Level-III3. Inclusion of "Container / closure integrity" test in the finished product
28.01.2014
specification for (Tetanus vaccine (Adsorbed) I.P.)
(Acknowledgement No 3944)
Level-III
4. To reduce the concentration of thiomersal in purified Tetanus toxoidpool from 0.001 % to 0.005 % 28.01.2014
(Acknowledgement No 3945)
Level-III
5. To discontinue the in-process testing for microbial contamination detection (MCDT) on the dispensed antigens (Tetanus Toxoids) and presevative (2 % thiomersal solution)
29.01.2014
(Acknowledgement No 4153 )
Level-III
6. Inclusion of "Particulate matter (visual) test in the finished product specification" (Tetanus vaccine (Adsorbed) I.P.) 29.01.2014
(Acknowledgement No 4156)
Level-III
7. Deletion of abnormal toxicity test at final bulk level of TT vaccine hence revision of respective MTR. 08.01.2015
(Acknowledgement No 736 )
Level-III
8. Elimination of Pooling process from manufaturing of purified tetanus toxoid Identifying of existing "Purified Tetanus Toxoid" which is directly used for drug product manufacturing
08.01.2015
(Acknowledgement No 741 )
Level-III
9. To reduce the concentration of thiomersal from 0.01 % to 0.005 % in Tetanus vaccine (Adsorbed). 03.02.2015(NOC F.No: 12-108/SIIL/PAC-TETANUS vaccine / 14-BD
Level-III
10. To remove the step of checking specific gravity of bulk liquid every day before filling for Tetanus Toxoid Vaccine Adsorbed
12.01.2016
(Acknowledgement No 1027)
Level-III
11. To incorporate the following in T-ELISA procedure for potency estimation of Tetanus component: I) Test sample validity criteria. 2) Comparability of each new conjugate lot is demonstrated by performing two independent assays using old and new conjugate lots. 3) To prepare and run positive control in each test to establish the assay validity. for Tetanus Toxoid Vaccine Adsorbed (CH15-627)
13.01.2016
(Acknowledgement No 1172)
Level-III
12. To start using OPC (One Point Cut) ampoules, in place of existing "Snap Off' ampoules, for Tetanus vaccine (Adsorbed) I.P.
11.01.2017
(Acknowledgement No 917)
