ARIES DRUGS PRIVATE LIMITED - 2.imimg.com2.imimg.com/data2/UD/UJ/MY-/smf-file.pdf · Integrated...
Transcript of ARIES DRUGS PRIVATE LIMITED - 2.imimg.com2.imimg.com/data2/UD/UJ/MY-/smf-file.pdf · Integrated...
Plot no. 90
Sector-IIDC, Sidcul,
Pant Nagar- 263 145,
UTTARAKHAND,
E-mail : [email protected]
Website : www.ariesdrugs.com
COMPANY’S RESPONSIBLE PERSON
NAME DESIGNATION
MR. HARIOM AGARWAL CHAIRMAN
MR. AMIT AGARWAL MANAGING DIRECTOR/ PLANT HEAD
MR. ROBIN MATHEW DIRECTOR
Mrs. MUKUL AGARWAL DIRECTOR
Mr. SUSHANT RAI AGARWAL H.R & ADMINISTRATION.
MR. ASHOK JAISWAL PRODUCTION IN-CHARGE
MR. KAILASH DASS QC IN-CHARGE
MR. ANOOP DUTTA STORE IN-CHARGE
SITE MASTER FILE
ARIES DRUGS PRIVATE LIMITED
CONTENTS 1. GENERAL INFORMATION
2. SPECIFIC INFORMATION
3. PREMISES, FACILITIES AND EQUIPMENTS
4. DOCUMENTATION
5. PRODUCTION
6. QUALITY CONTROL
7. CONTRACT MANUFECTURER & LICENSEE
8. DISTRIBUTION, COMPLAINTS, & PRODUCT RECALLS
9. SELF- INSPECTION
10. FLOW CHARTS - PRODUCTION DEPARTMENT:
� Material Movements & Oral Liquid Production
11. FLOW CHARTS - QUALITY CONTROL DEPARTMENT:
� Sterility testing Packaging Material Analysis & Release
� In-process QA/QC & Finished Product Analysis
� Raw Material Analysis & Release
12. LIST OF PRODUCTS
13. SOP INDICES
� Quality Control
� Production
� Stores
� Administration
� Store Department
� Water System
14. PRODUCTION MACHINERY
15. QUALITY CONTROL EQUIPMENTS
16. ORGANIZATION CHART:
� Company Organ gram
17. FLOW CHARTS: Engineering
� Store Management System
� Water System
� Preventive Maintenance Schedule
18. MANPOWER STRENGTH
ARIES DRUGS PRIVATE LIMITED
1.0 GENERAL INFORMATION
1.1 Brief information of the Company
Aries drugs Pvt. Ltd. Was established in 2005 on the 4th
day of April at LUCKNOW with five Directors.
The company was established with 22 Medical representatives and five managers for its own marketing
in Uttar Pradesh state. Aries started with the complete B2 range of products including Tablets, Capsules
& Oral Liquids for its marketing; earlier the products were getting manufactured from Himachal &
Haryana State under strict quality parameters.
The vision of the company was to establish its own manufacturing unit within next four to five years.
Therefore in this regard the company purchased the land for the manufacturing unit in Uttarakhand
Integrated Industrial Estate at Pantnagar, Rudrapur.
Aries now has established its own manufacturing unit specializing in Oral Liquid Plant only.
This manufacturing facility has been designed with modern, automated processes, utilities and
equipments conforming to national standards and cGMP norms amended from time to time. Facility has
the capacity to produce complete Oral Liquid Unit. Using modern equipments, This manufacturing
facility is national regulatory compliant and is futuristically designed. In our company has fully
automatic equipments/Instruments for manufacturing. In all department supply fresh air & AHU with
0.5µ filter.
1.2 Manufacture of pharmaceutical products
The facility is dedicated for production of Antibiotics, Multivitamins, Cough Syrup, and
Antialargic. All the above products are manufactured in the following dosage forms in Oral
Liquid :
Manufacturing License No. 17/UA/2009 IN FORM No. 25 and Manufacturing License No.
19/UA/SC/P-2009 in Form No. 28 are issued by Uttarakhand Drug Licensing Authority.
1.3 Our Contact details:
a) Manufacturing Site: b) Head Office :
PLOT NO.90, SECTOR-IIDC, Aries Drugs Pvt. Ltd.
SIDCUL, PANTNAGAR-263145.(U.K) S-89/16, D-Block, Rajajipuram, E-mail : [email protected] Lucknow-226017.
Website : www.ariesdrugs.com Tel No. 0522-3298260
Mobile : 09335291145/46/47
Tel No : (05944) 250546,
Mobile : 0 9335291146 / 0 9335291145
1.4 Details of our Products and Process:
PRODUCTION FLOW CHARTS
RAW & PACKING MATERIAL MOVEMENT
RM/PM Receipt
Sampling, Testing
Approved
Material store
Dispensing
In-process
Sampling
Testing
Semi Finished
Product
Sampling
Testing
Packaging Finished
Product
Quality
Approved
De Dusting &
Record
Rejected
Rejection Report Passes
Passes
Primary PM
Rejection
Report
Passes
Dispatch
Rework
Recection. RM
Return to party
Unprinted PM
Return to party
Printed PM
Destroy
Destroy
1.5 REFER LIST OF PRODUCTS
LIST OF PRODUCTS
Sr No BRAND NAME COMPOSITION PACK
1. POLYFER SYRUP
Each 5 ml contain.
IRON (III) HYDROXIDE
POLYMALTOSE COMPLEX 50mg.
FOLIC ACID I.P. 0.5mg
200 ML
2. ARIZYME SYRUP Each 5 ml contain.
FUNGAL DIASTASE(1:12000) I.P. 50mg.
PEPSIN(1:3000) I.P. 10mg. 200 ML
3. FECAL SYRUP
Each 5 ml contain.
FERROUS GLUCONATE I.P. 300mg.
CALCIUM GLUCONATE I.P. 125mg.
CYANOCOBALMINE I.P. 10mcg.
FOLIC ACID I.P. 1.5mg
200 ML
4. ARIFER SYRUP Each 5 ml contain.
SODIUM FEREDETATE B.P. 231mg.
FOLIC ACID I.P. 0.5mg. 200ML
5. SEAGEM-L SUSPENSION
Each 5 ml contain.
CALCIUM CARBONATE
(OYSTER SHELL) I.P. 625mg.
VITAMIN D3 I.P. 125 I.U
L-LYSINE USP 70mg.
200ML
6. NOVACID SUSPENSION
Each 5 ml contain.
MAGALDRATE I.P. 400mg.
SIMETHICONE I.P. 20mg.
170 ML
7. CETEN SYRUP Each 5 ml contain. CETIRIZINE
DIHYDROCHLORIDE BP 5mg 60 ML
8. SUPAR SUSPENSION Each 5 ml contain.
NIMESULIDE B.P. 50mg.
PARACETAMOL I.P. 125mg. 60 ML
9. ARO SUSPENSION Each 5 ml contain.
OFLOXACIN . I.P. 50mg
60 ML
10. ARO-OZ SUSPENSION Each 5 ml contain.
OLFLOXACIN I.P. 50mg.
ORNIDAZOLE 125mg. 60 ML
11. AROMET SUSPENSION
Each 5 ml contain.
OFLOXACIN I.P. 100mg. METRONIDAZOLE BENZOATE
(EQ. TO METRONIDAZOLE) I.P. 200mg.
60 ML
12. ARITONE SYRUP
Each 5 ml contain.
CHLORPHENIRAMINE
MALEATE I.P. 2.5mg.
AMMONIUM CHLORIDE I.P. 125mg.
SODIUM CITRATE I.P. 55mg.
MENTHOL I.P. 1mg.
100ML
13 ARYDRYL SYRUP
Each 5 ml contain.
DIPHENHYDRAMINE HCL I.P. 14.08mg.
AMMONIUM CHLORIDE I.P. 138mg.
SODIUM CITRATE I.P. 57.03mg.
MENTHOL I.P. 1.14mg.
100 ML
14. BROX-CZ SYRUP
Each 5 ml contain.
BROMHEXINE HCL I.P. 4mg.
GUAIPHENESIN I.P. 50mg.
CETIRIZINE
DIHYDROCHLORIDE B.P. 2.5mg.
MENTHOL I.P. 1mg.
100ML
15 ARIFATE –O SUSPENSION
Each 10 ml contain.
SUCRALFATE USP 1mg.
OXETACAINE B.P. 10mg.
100ML
16. NOCOLD SYRUP
Each 5 ml contain.
PARACETAMOL I.P. 125mg.
PHENYLPROPANOLAMINE
HCL B.P. 2.5mg.
CHLORPHENIRAMINE
MALEATE I.P. 1mg.
100ML
17. CYPOT SYRUP
Each 5 ml contain.
CYPROHEPTADINE HCL . I.P. 2mg.
TRICHOLINE CITRATE 0.275gm
SORBITOL SOLUTION(70%) I.P. 3.575gm
200 ML
18. CITRAL SYEUP Each 5 ml contain.
DISODIUM HYDROGEN
CITRATE B.P. 1.53gm 100 ML
19. ARICOF SYRUP
Each 5 ml contain.
DEXTROMETHORPHAN
HYDROBROMIDE I.P. 10mg.
PHENYLPROPANOLAMINE
HCL B.P 10mg.
CHLORPHENIRAMINE
MALEATE I.P 2mg.
MENTHOL I.P. 1.5mg
100 ML
20. NSP SUSPENSION
Each 5 ml contain.
NIMESULIDE B.P. 50mg.
PARACETAMOL I.P. 125mg.
60ML
21. ARICID SUSPENSION
Each 5 ml contain.
DRIED ALUMINIUM
HYDROXIDE GEL I.P. 200mg.
MAGNESIUM HYDROXIDE I.P. 200mg.
SIMETHICONE I.P. 25mg.
170ML
22 OFCIN SUSPENSION Each 5 ml contain.
OFLOXACIN . I.P. 50mg.
60 ml
23. OFCIN-OZ SUSPENSION Each 5 ml contain.
OFLOXACIN I.P. 50mg.
ORNIDAZOLE 125mg. 60ML
24. LIVOTOP SYRUP
Each 5 ml contain.
CYPROHEPTADINE HCL . I.P. 2mg.
TRICHOLINE CITRATE 0.275gm
SORBITOL SOLUTION(70%) I.P. 3.575gm
200ML
25. LCTONE SURUP
Each 5 ml contain.
CHLORPHENIRAMINE
MALEATE I.P. 2.5mg.
AMMONIUM CHLORIDE I.P. 125mg.
SODIUM CITRATE I.P. 55mg.
MENTHOL I.P. 1mg.
100ML
26. ARIFATE SUSPENSION Each 10 ml contain.
SUCRALFATE USP 1gm.
100ML
27. PEPZYME SYRUP
Each 5 ml contain.
FUNGAL DIASTASE(1:1200) I.P. 50mg.
PEPSIN(1:3000) I.P. 10mg
200ML
28. CALCITONE-F SYRUP
Each 5 ml contain.
FERROUS GLUCONATE I.P. 300mg.
CALCIUM GLUCONATE I.P. 125mg.
CYANOCOBALMINE I.P. 10mcg.
FOLIC ACID I.P. 1.5mg
200ML
29. CARBOZ-SYRUP
Each 5 ml contain.
CARBONYL IRON EQ. TO
ELEMENTAL IRON 60mg.
VIT. B12 I.P. 7.5mcg.
FOLIC ACID I.P. 0.75mg.
ZINC(as zinc sulphate I.P.) 11.25mg.
200ML
1.6 Site Synopsis:
The site is situated at Integrated Industrial Estate, Pant Nagar about 5 km away from Rudrapur
city (Uttarakhand). It is accessible by rail as well as by road, about 237 km from Delhi, and
about 300 km from Dehradun. The total area of the plot is approximately 1971.40 sq. yard. The
plot is situated in pollution free environment.
1.7 Human Resource :
Sr. No. Department Strength
1. Production staff
04
2. Quality Control
03
4. Engineering Services
02
5. Stores
02
6. Administration
03
7. Security
02
9. House keeping
05
10. Regulatory
01
11 Operator 05
Total 27
2.0 PERSONNEL
2.1 LIST OF KEY TECHNICAL PERSONNEL AT PANTNAGAR SITE
Company’s Responsible Person
Sr. No. Name Brief Biodata
01 Mr. Amit Agarwal
Designation - Managing Director/ Plant Head
Education - B.Com
Experience - Looking after the entire portfolio of
Aries which includes the Sales,
marketing, Legal & periodicals and
manufacturing
02 Mr. Ashok Jaiswal
Designation - Production In-Charge
Education - B.Sc
Experience – 7 years experience in production,
Approved from Uttaranchal
government in Tablet, Capsule
& Liquid section
03 Mr. Kailash Dass
Designation - QC In-Charge
Education - B.Sc
Experience – 4 years experience in QC Department,
Approved from Uttaranchal
government in Chemical analysis
04 Mr. Anoop Dutta
Designation - Store In-Charge
Education - B.Com
Experience – 3 years experience in store department
2.2 Health Requirement :
The company ensures that pre-employment and periodical medical check up is conducted for all
employees.
2.3 Training Program :
A detailed SOP for Training Program and a Training Manual is prepared by QC, in consultation
with Plant head, HR and Departmental heads. This covers Induction training, On the job training,
External training in cGMP, Health, Safety, Environment, personnel hygiene, instrumentation.
The trainings conducted are documented and evaluated.
3.0 PREMISES, FACILITIES AND EQUIPMENT:
PREMISES:
3.1 Manufacturing areas:
Manufacturing facilities are segregated as per cGMP norms and separate buildings have been
provided for Specialty Formulations, Oral Liquid Section.
3.2 Nature of construction and fixtures / fittings:
Nature of construction : Brick & RCC
External finish : Cement plaster with snowcem finish
Internal Finish : The manufacturing areas are made up of
a. Stone Flooring
b. Polyurethane coatings on walls and ceilings.
In other areas, Internal walls and ceilings are plastered with cement to smooth finish and painted
with glossy washable antibacterial and antifungal paint. Peripheral areas, which are other than
the production areas, are constructed by civil structure.
3.3 Water System (DM water)
RO UNIT :- Model- INDRO-403 , MAKE – ION EXCHANGE INDIA LIMITED.
The water treatment system consists of treatment of water at various stages and passage through
various filters as per the details given below:
• Bore well source is from artesian well designed to feed water
• Filtration through multi-grade filter
• Softener
• Antiscallent dosing
• RO
• Mix bed
• pH Stabilization
• Pass through UV.
• DM water
3.4 Distribution of DM Water:
The distribution loops are made of SS with orbital arc welding and continuous flow of water
with the provision of sampling points and user points, wherever required.
3.5 Preventive Maintenance:
The preventive maintenance of the systems, building and premises including painting is carried
out as per schedule.
The ventilation and water systems are periodically serviced and checked for overall
performance.
Records are maintained as follows:
The equipments are divided into -
a) Utility Equipments
b) Production Equipments
Preventive maintenance documents are maintained separately. The schedule for preventive
maintenance is formulated on annual basis for each manufacturing unit with specific break up of
weekly / fortnightly / monthly / quarterly and half-yearly maintenance schedules.
A list of major equipments and machinery used in production has been attached.
3.6 Validation and Calibration
Validation Master Plan is prepared by QC in line with the philosophy of Aries Drugs Private
Limited to plan and execute validation activities in the facility according to Validation Matrix.
All critical equipments, instruments and utilities are subjected to followed by DQ, IQ, OQ and
PQ. In case of any changes, revalidation is performed accordingly.
Records are kept with detailed information for each equipment such as details of calibration
standards and limits, responsibilities for performing calibration, intervals between calibration,
record-keeping requirements and logs, and actions to be taken. The following validations are
carried out:
• Water Validation
• Equipment Validation
• QC Instrument / Analytical Method Validation
Calibration of equipments by external agencies is carried out periodically and the tag indicating
next calibration due is affixed on individual equipment.
3.7 SANITATION
Sanitation and Cleaning to ensure that the system is cleaned properly to be free from product,
detergent and microbial flora to specified level to prevent contamination.
Written guidelines and procedures for cleaning specifications, cleaning agents and their
concentration to be used are available.
In critical process areas, the equipments / machinery have been provided with CIP and SIP
systems. Written SOPs are in place for cleaning and sanitization of manufacturing areas.
Separate SOPs are available for cleaning of individual equipment / machinery, which are
followed, & records are maintained thereof.
4.0 DOCUMENTATION
4.1 Documentation is an essential part of the Quality Assurance/Quality Control System. Its purpose
is to define the system control and to specify / record various activities carried out and to ensure
effective implementation.
Documentation system includes the history for each batch of product. It includes the
information on utilization and processing of starting materials, packaging materials and
intermediate, bulk and finished products.
Master documents such as Master Specification, Master Formula Card and Master File for each
raw material, packing material and finished product are available with QA/QC department.
5.0 PRODUCTION
5.1 Materials are procured from approved vendors against purchase order. The materials received at
warehouse are cleaned free of dust by vacuum cleaner, checked for physical defects and kept in
quarantine till QC sampling is done. After the QC Report, approved materials are shifted to
Approved Area and if rejected, transferred to Rejected Materials Area. Rejected materials are
kept under lock and key till they are returned to the vendor in case of raw materials and till they
are destroyed, in case of printed packing materials.
QC sampling and dispensing of raw materials is done under the specified areas. Dispensed
materials are moved to ‘Day Store’ till taken up for production.
After production, the finished goods are maintained in the quarantine pending QC release. Once
the QC release is obtained, the finished products are transferred to BSR.
FACILITIES:
� Documentation (cGMP)
� Latest Equipment/Instruments for manufacturing.
� AHU with 0.5µ filter.
� Fresh air system
� Cooling system
� Fresh air & AHU with 0.5µ filter In Manufacturing & packing area.
5.2 Flow sheets ORAL LIQUID PRODUCTION
SAMPLING TESTING
QC RELEASE
BATCH MANUFACTURING
RECORD
RAW MATERIAL
REQUISITION
(FORMULATION ORDER)
DISPENSING OF RAW
MATERIALS
MANUFACTURING
PROCESS
PACKAGING
PACKING MATERIAL
REQUISITION
LABELING
RELEASE FOR
PACKING
FILLING
DISPENSING OF PM
BULK
IPQC
IPQC
SAMPLING &
INSPECTION
QC RELEASE
TRANSFER TO
STORE
DEPARTMENT
5.3 LIST OF MAJOR EQUIPMENT AT PLANT
ORAL LIQUID SECTION
S.NO. NAME OF THE EQUIPMENT MAKE MODEL
1
Sugar preparation tank with double
Heater.
(Capacity 750 Lit.)
Pyramid Industries
(Ahmadabad) GMP Model
2
Manufacturing tank with stirrer and cooling
facilities and In Line Homogenizer.
( Capacity 1000 Lit.)
Pyramid Industries
(Ahmadabad) GMP Model
3 Filter Press Pyramid Industries -
4 Storage tank with stirrer
( Capacity 1000 Lit.)
Pyramid Industries
(Ahmadabad) GMP Model
5 Rotary Bottle washing machine
with air dryer
Excel Engineering
(Ahmadabad)
ERWM-64
6 Automatic four head Volumetric Liquid
Bottle Filling machine
National Pharma
Machinery NALF-100
7 Automatic four head Cap Sealing machine National Pharma
Machinery NARCS-100
8 Automatic cap feeder machine National Pharma
Machinery NARCS-100
9 Inspection table Excel Engineering
(Ahmadabad) EPCB
10 Labeling machine with vacuum system
Koldpack Machineries
P. Limited (Ahmadabad)
KHL-ISO
6.0 QUALITY CONTROL
Quality Control laboratories have been equipped with latest equipments & Instruments.
6.1 Quality control shall deal with sampling, specifications, testing, documentation, release
procedure and ensure implementation of the relevant protocol
The QC Lab has got the following sections:
• Chemical
• Instrumentation
• Packing materials testing
• Microbiology
• Re-agents and storage
• Control Samples
• Record Room
• Heating Equipments Area
• Stability Studies
• Wash Area
6.2 FACILITIES
General facilities
The testing facility of analytical lab are designed as
� Instrumentation lab
� Chemical analysis lab
� Microbiology lab
Specimen and data storage facilities
Separate Room and cupboards are provided for storing the samples before and after
analysis. All analytical data are entered in a prescribed protocol sheet based on which a
test report is prepared. The data are filed according to the serial number of COA.
Administrative and personnel facilities
All the administrative work related to the laboratory are supervised by
QC In charge.
Facilities for hand-wash and toilet are adequately provided.
6.3 Quality Management System:
Our policy states:
“The commitment of the company is to ensure, that the products it develops, manufactures and
distributes, meet the predetermined specification related to quality of its products consistently”.
It assures the products are manufactured in adherence to the current Good Manufacturing
Practices (cGMP) in conformity with national regulations.
The role of Quality Quality Control is to ensure design and development of pharmaceutical
products taking into account the requirements of Good Manufacturing Practices (GMP), Good
Laboratory Practices (GLP) Good Documentation Practices (GDP). Adequate controls on
starting materials, bulk products and other in-process controls, calibrations and validations are
carried out.
The effective quality management is achieved through systematic sampling, testing, validating
and monitoring of materials, facilities, systems and procedures, which can have direct impact on
the quality of the products throughout their shelf life. Much importance is given to in-process
controls on the guidelines given under Process The Standard Operating Procedures (SOPs), duly
authorized for all operations including Production, Quality Control, Distribution, Safety,
Environmental Control, Housekeeping and Engineering are the other important part of Quality
Management System.
Self-inspection and Audits are part of effective implementation of Quality Management
System. Inspection, evaluation, rating and approval of vendors for supplies of raw
materials, excipients and packing materials are carried out in conformity to the Good
Manufacturing Practices.
6.4 LIST OF EQUIPMENTS / INSTRUMENTS IN QA/QC LAB
Sr. No. Equipment / Instrument
Name
Make Model Qty
1. UV-Vis. Spectrophotometer Systronics 117 1
2. Refractometer Advance R-8 1
3. K. F. Titrator EI 761 1
4. Analytical Balance Vibra HT-220E 1
5. Polarimeter Advance PA-1R 1
6. pH Meter Toshcon CL 54+ 1
7 Conductivity Meter Toshcon TCM 15+ 1
8 Melting Point apparatus EI 931 1
9 Muffle Furnace Shivaki T-701 1
10 Hot air Oven J.S. Enterprises - 1
11 Vacuum Oven S.M. Scientific - 1
12 Water Bath J.S. Enterprises - 1
13 Hot plate J.S. Enterprises - 1
14 Heating mantel J.S. Enterprises - 1
15 UV Cabinet J.S. Enterprises - 1
6.5
QC FLOW SHEET
IN PROCESS AND FINISHED PRODUCTS ANALYSIS
DISPENSING
BULK SOLUTION
Description
pH
Fill volume
Wt./ml
Assay
TEST:
1- PHARMACOPOEAL SPECIFICATIONS
2- IN HOUSE SPECIFICATIONS
6.6 PACKAGING MATERIAL ANALYSIS AND RELEASE
PRIMARY PACKAGING MATERIAL& SECONDARY PACKING MATERIALS
PRIMARY SECONDARY
PET BOTTLE PP CAP LABEL CARTON CORRUGATED
BOX
PHYSICAL
DIMENSIONS
PHYSICAL
DIMENSIONS
PHYSICAL
DIMENSIONS
PHYSICAL
DIMENSIONS
PHYSICAL
DIMENSIONS
CHEMICAL
TESTING
CHEMICAL
TESTING
CHECKING OF
PRINTED MATTER
CHECKING OF
PRINTED MATTER
GRAMMAGE &
PRINTED MATTER
COMPLIES
COMPLIES
COMPLIES
COMPLIES
COMPLIES
RELEASE
RELEASE
RELEASE
RELEASE
RELEASE
7.0 STORE DEPARTMENT
General facilities
� Documentation
� Separate Under Test area with yellow coloured mark on floor.
� Separate Approved area with Green coloured mark on floor.
� Separate Rejected area with Red coloured mark on floor.
� Cooling area
� Dispensing & Sampling Booth with LAF
� Cold storage area for Multivitamins and other raw material.
� Finish goods storage area.
� Primary & Secondary Packing materials area.
8.0 CONTRACT MANUFACTURE & LICENSE SHEET
The Contract Manufacturing can be undertaken on either as Loan License or principle to
principle (P to P) basis.
In P to P basis- All the materials shall be arranged by the manufacturer & License shall also be
arranged by manufacturer under the brand name of marketing company.
The Loan License- Under the Loan license The Manufacturing is done with the materials
supplied by the Licensee & the license for the manufacturing is to be arranged by the marketing
company at our premises.
All the manufacturing activities are done under strict supervision of technical staff following
latest cGMP norms.
9.0 DISTRIBUTION, COMPLAINTS AND PRODUCT RECALL
Warehousing areas are designed and good storage and distribution practice are adopted.
The areas are maintained within acceptable temperature limit. Controlled storage condition is
monitored constantly.
Distribution details are maintained batch wise to facilitate recall of goods, if required.
9.1 Handling of Complaints and Product Recalls
A Standard Operating Procedure is available for the handling of complaints and Product Recall
Procedure is in place. Complaints will be investigated by QC department as per written
procedure and the QC Manager instructs further action / recall.
9.2 SELF-INSPECTION
Periodical internal audits (self inspection) are carried out as per the SOP of Internal Audit.
Internal audit is either conducted by the internal audit team or by authorized QA/QC personnel.
Internal auditors, who form the audit team, are selected from various departments except the
auditee department.
The auditors prepare internal audit reports and the concerned Department Head is required to
submit the corrective action plan.
External experts are also called periodically to evaluate our working on the principles of GMP,
GLP, GDP.
10.0 ORGANIZATION CHART:
ORGANOGRAM OF PANTNAGAR SITE
_________________________________________________________
__________________________
Mr. HARIOM AGARWAL
CHAIRMAN
Mr. AMIT AGARWAL
(DIRECTOR & PLANT HEAD)
Mr. ROBIN MATHEW
(DIRECTOR)
Mr. ASHOK JAISWAL
(PRODUCTION INCHARGE)
Mr. KAILASH DASS
(QC INCHARGE)
Mr. ANOOP DUTTA
(STORE INCHARGE)
Mr. SUSHANT RAI AGRWAL
(H.R & ADMINISTRATION.)
Mrs. MUKUL AGARWAL
(MARKETING DIRECTOR)
MARKETING MANAGER
MEDICAL
REPRESENTATIVES
DISTRIBUTORS