ZL302_00_001e_FO Quality variation requiring approval · Web viewIn order to levy fees...

VO-FormQuality variation requiring approval

This form cannot be used for variations during ongoing initial authorisation procedures.

Authorisation no.: ……

Product name(s):……

Dosage form(s):……

When completing this form, please note the following: In order to levy fees correctly, a difference is made between human medicines (synthetic drugs,

biotechnological drugs, vaccines and blood products), veterinary medicines, complementary and herbal medicines, allergens and radiopharmaceuticals.

The criteria for classifying a quality variation requiring approval as “major” or “minor” are defined in the guidance document Variations related to quality changes requiring approval. For a variation, only the box for "major" or "minor" changes need be checked, but not both. If several parameters change for one type of variation (e.g. specifications of the finished product), e.g. if:a) one major and one minor change are applied for, click only once the box for a "major" change.b) three minor changes are applied for, click only once on the box for a "minor" change.

The text fields “Scope / justification for the change” and “Present” - “Proposed” must be completed. References to the documentation or codes internal to the firm are not sufficient. This form may be used to submit several applications for quality variations requiring approval at the same time.

Changes that are justified as “consequential” to a proposed variation requiring approval (consequential change) must be described in the text field "Consequential change“ and justified. To identify the variations precisely, the SAP number (taken from this form) must be stated for variations requiring approval. For variations requiring notification, please state the number in accordance with Annex 8, AMZV (Nos. 1 - 48). When defining the level of the variation, please note the following. When applying for a "minor quality variation" requiring approval, only a "minor quality variation" or a consequential variation requiring notification may follow, but not a "major quality variation”. All consequential changes are subject to the same deadlines as variations requiring approval, and no additional fee is charged.

„The box "Other quality changes" should only be checked if the variation does not apply to any of the other types of variation proposed: otherwise, the application will not comply with the formal requirements.

For grouped applications, only those variations relating to the grouped application can be submitted on the same form. The first page of the form should include all the authorisation numbers, product names and pharmaceutical forms concerned.

The undersigned confirms that the details provided are complete and correct:(Company stamp of applicant)

……

Compulsory Optional (additional signature)

Location, date: ……

Signature: …………………………………….

Responsible personFirst name: ……Surname: ……Position held: ……

Location, date: ……

Signature: ....................................................

Additional personFirst name ……Surname: ……Position held: ……

QM-Ident: ZL302_00_001e_FO / V08 / wer, its / dts / 01.01.2015 1 / 57

Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12


ACTIVE PHARMACEUTICAL INGREDIENTManufacturer of the active pharmaceutical ingredient (HSWS)

Change in the manufacturer of a starting material / reagent / intermediate used in the manufacturing process of the active pharmaceutical ingredient or change in the manufacturer of the active pharmaceutical ingredient. Change to quality control testing sites of the active pharmaceutical ingredient. (EU B.I.a.1)

major SAP Nr. minor SAP Nr.Human Medicines ☐ (2090) ☐ (2248)Veterinary medicines ☐ (2093) ☐ (2252)Complementary and herbal medicines ☐ (2091) ☐ (2249)Allergens ☐ (2836) ☐ (2250)Radiopharmaceuticals ☐ (2092) ☐ (2251)Advanced therapy products ☐ ☐ (3004)

Scope / justification for the change……

Present Proposed…… ……

Consequential change

Quality variation requiring approval SAP Nr.: ……Variations requiring notification Nr.: ……






Manufacturing process of the active pharmaceutical ingredient (HSPWS)Change in the manufacturing process of the active pharmaceutical ingredient. (EU B.I.a.2)

major SAP Nr. minor

SAP Nr.

Human Medicines ☐ (2094) ☐ (2253)Veterinary medicines ☐ (2097) ☐ (2256)Complementary and herbal medicines ☐ (2095) ☐ (2254)Allergens ☐ (2837) ☐ (2852)Radiopharmaceuticals ☐ (2096) ☐ (2255)Advanced therapy products ☐ ☐










Batch size of active pharmaceutical ingredient (CHWS)Change in batch size (including batch size ranges) of active pharmaceutical ingredient or intermediate used in the manufacturing process of the active pharmaceutical ingredient. (EU B.I.a.3)

major SAP Nr. minor

SAP Nr.











In-process tests of the active pharmaceutical ingredient (IPCWS)Change to in-process tests or limits applied during the manufacture of the active pharmaceutical ingredient. (EU B.I.a.4)

major SAP Nr. minor

SAP Nr.











Annual Update Influenza Vaccine (AUI)Changes to the active pharmaceutical ingredient of a seasonal vaccine against human influenza. (EU B.I.a.5)

major SAP Nr.Human Medicines ☐ (2108)










Specifications of the active pharmaceutical ingredient (SPWS)Change in the specification parameters and/or limits of an active pharmaceutical ingredient, starting material / intermediate / reagent used in the manufacturing process of the active pharmaceutical ingredient. (EU B.I.b.1)

major SAP Nr. minor

SAP Nr.











Test procedures for the active pharmaceutical ingredient (PMWS)Change in test procedures for active pharmaceutical ingredient or starting material/reagent/intermediate used in the manufacturing process of the active pharmaceutical ingredient. (EU B.I.b.2)

major SAP Nr. minor

SAP Nr.











Immediate packaging of the active pharmaceutical ingredient (PVWS)Change in immediate packaging of the active pharmaceutical ingredient. (EU B.I.c.1)

major SAP Nr. minor

SAP Nr.











Specifications of the immediate packaging of the active pharmaceutical ingredient (SPPVWS)Change in the specification parameters and/or limits of the immediate packaging of the active pharmaceutical ingredient. (EU B.I.c.2)

minor SAP Nr.Human Medicines ☐ (2280)Veterinary medicines ☐ (2284)Complementary and herbal medicines ☐ (2281)Allergens ☐ (2282)Radiopharmaceuticals ☐ (2283)Advanced therapy products ☐










Test procedures for the immediate packaging of the active pharmaceutical ingredient (PMPVWS)Change in test procedures for the immediate packaging of the active pharmaceutical ingredient. (EU B.I.c.3)











Stability of the active pharmaceutical ingredient (STWS)Change in the re-test period/storage period or storage conditions of the active pharmaceutical ingredient. (EU B.I.d.1)

major SAP Nr. minor

SAP Nr.











Design Space for the active pharmaceutical ingredient (DSWS)Introduction of a new design space or extension of an approved design space. (EU B.I.e.1)

major SAP Nr.Human Medicines ☐ (2126)Veterinary medicines ☐ (2129)Complementary and herbal medicines ☐ (2127)Allergens ☐ (2841)Radiopharmaceuticals ☐ (2128)Advanced therapy products ☐










Introduction of a Change Management Protocol related to the active pharmaceutical ingredient (ECMPWS)Introduction of a post approval change management protocol. (EU B.I.e.2)











Deletion of a Change Management Protocol related to the active pharmaceutical ingredient (SCMPWS)Deletion of an approved change management protocol. (EU B.I.e.3)

minor SAP Nr.Human Medicines ☐ (2938)Veterinary medicines ☐Complementary and herbal medicines ☐Allergens ☐Radiopharmaceuticals ☐Advanced therapy products ☐










Changes to a Change Management Protocol related to the active pharmaceutical ingredient (CMPWS)Changes to an approved change management protocol. (EU B.I.e.4)

major SAP Nr. minor

SAP Nr.

Human Medicines ☐ (2933) ☐ (2939)Veterinary medicines ☐ ☐Complementary and herbal medicines ☐ ☐Allergens ☐ ☐Radiopharmaceuticals ☐ ☐Advanced therapy products ☐ ☐










Implementation of a Change Management Protocol related to the active pharmaceutical ingredient (ICMPWS)Implementation of changes foreseen in an approved change management protocol. (EU B.I.e.5)











FINISHED PRODUCTMarkings of the finished product (KFP)Change or addition of imprints, bossing or other markings including replacement, or addition of inks used for product marking. (EU B.II.a.1)











Shape / dimensions of the finished product (FFP)Change in the shape or dimensions of the pharmaceutical form. (EU B.II.a.2)

major SAP Nr. minor

SAP Nr.

Human Medicines ☐ (2934) ☐ (2299)Veterinary medicines ☐ ☐ (2303)Complementary and herbal medicines ☐ ☐ (2300)Allergens ☐ ☐ (2301)Radiopharmaceuticals ☐ ☐ (2302)Advanced therapy products ☐ ☐










Composition of the finished product (ZSFP)Changes in the composition (excipients) of the finished product. (EU B.II.a.3)

major SAP Nr. minor

SAP Nr.











Weight of coating / capsule of the finished product (GFP)Change in coating weight of oral dosage forms or change in weight of capsule shells. (EU B.II.a.4)

major SAP Nr. minor

SAP Nr.











Concentration of a parenteral finished product (KPFP)Change in concentration of a single-dose, total use parenteral product, where the amount of active pharmaceutical ingredient per unit dose (i.e. the strength) remains the same. (EU B.II.a.5)











Deletion of the solvent container of the finished product (LFP)Deletion of the solvent / diluent container from the pack. (EU B.II.a.6)

minor SAP Nr.

Human Medicines ☐ (2314)Veterinary medicines ☐ (2318)Complementary and herbal medicines ☐ (2315)Allergens ☐ (2316)Radiopharmaceuticals ☐ (2317)Advanced therapy products ☐










Manufacturing site of the finished product (HSFP)Replacement or addition of a manufacturing site for part or all of the manufacturing process of the finished product. (EU B.II.b.1)

major SAP Nr. minor

SAP Nr.











Quality control testing / batch release of the finished product (QFP)Change to importer batch release arrangements and quality control testing of the finished product. (EU B.II.b.2)

major SAP Nr. minor

SAP Nr.











Manufacturing process of the finished product (HSPFP)Change in the manufacturing process of the finished product including an intermediate used in the manufacture of the finished product. (EU B.II.b.3)

major SAP Nr. minor

SAP Nr.











Batch size of the finished product (CHFP)Change in the batch size (including batch size ranges) of the finished product. (EU B.II.b.4)

major SAP Nr. minor

SAP Nr.











In-process tests of the finished product (IPCFP)Change to in-process tests or limits applied during the manufacture of the finished product. (EU B.II.b.5)

major SAP Nr. minor

SAP Nr.











Specifications of an excipient (SPHS)Change in the specification parameters and/or limits of an excipient. (EU B.II.c.1)

major SAP Nr. minor

SAP Nr.











Test procedures for an excipient (PMHS)Change in test procedures for an excipient. (EU B.II.c.2)

major SAP Nr. minor

SAP Nr.











Source of an excipient (HHS)Change in source of an excipient or reagent with TSE risk. (EU B.II.c.3)

major SAP Nr. minor

SAP Nr.











Synthesis of an excipient (SHS)Change in synthesis or recovery of a non-pharmacopoeial excipient (when described in the dossier) or a novel excipient. (EU B.II.c.4)

major SAP Nr. minor

SAP Nr.











Specifications of the finished product (SPFP)Change in the specification parameters and/or limits of the finished product. (EU B.II.d.1)

major SAP Nr. minor

SAP Nr.











Test procedures for the finished product (PMFP)Change in test procedure for the finished product. (EU B.II.d.2)

major SAP Nr. minor

SAP Nr.











Real-time release of the finished product (EFP)Variations related to the introduction of real-time release or parametric release in the manufacture of the finished product. (EU B.II.d.3)











Immediate packaging of the finished product (PVFP)Change in immediate packaging of the finished product. (EU B.II.e.1)

major SAP Nr. minor

SAP Nr.











Specifications of the immediate packaging of the finished product (SPPVFP)Change in the specification parameters and/or limits of the immediate packaging of the finished product. (EU B.II.e.2)











Test procedures for the immediate packaging of the finished product (PMPVFP)Change in test procedure for the immediate packaging of the finished product. (EU B.II.e.3)











Shape of the immediate packaging of the finished product (FPVFP)Change in shape or dimensions of the container or closure (immediate packaging). (EU B.II.e.4)

major SAP Nr. minor

SAP Nr.











Fill volume of the finished product (VFP)Change in the fill weight/fill volume of the medicinal product. (EU B.II.e.5.c+d)

major SAP Nr. minor

SAP Nr.











Part of the immediate packaging of the finished product (BPVFP)Change in any part of the (primary) packaging material not in contact with the finished product formulation (such as colour of flip-off caps, colour code rings on ampoules, change of needle shield (different plastic used)). (EU B.II.e.6)

minor SAP Nr.Human Medicines ☐ (2394)Veterinary medicines ☐ (2398)Complementary and herbal medicines ☐ (2395)Allergens ☐ (2396)Radiopharmaceuticals ☐ (2397)Advanced therapy products ☐ (3003)










Supplier of the immediate packaging of the finished product (LPVFP)Change in supplier of packaging components or devices (when mentioned in module 3 / part II of the dossier). (EU B.II.e.7)

major SAP Nr. minor

SAP Nr.











Stability of the finished product (STFP)Change in the shelf-life and/or storage conditions of the finished product. Change in the in-use shelf-life and/or storage conditions after first opening, dilution or reconstitution of the finished product. (EU B.II.f.1)

major SAP Nr. minor

SAP Nr.











Design Space for the finished product (DSFP)Introduction of a new design space or extension of an approved design space for the finished product. (EU B.II.g.1)











Introduction of a Change Management Protocol related to the finished product (ECMPFP)Introduction of a post approval change management protocol. (EU B.II.g.2)











Deletion of a Change Management Protocol related to the finished product (SCMPFP)Deletion of an approved change management protocol. (EU B.II.g.3)











Changes to a Change Management Protocol related to the finished product (CMPFP)Changes to an approved change management protocol. (EU B.II.g.4)

major SAP Nr. minor

SAP Nr.











Implementation of a Change Management Protocol related to the finished product (ICMPFP)Implementation of changes foreseen in an approved change management protocol. (EU B.II.g.5)











Adventitious Agents (AA)Update to the “Adventitious Agents Safety Evaluation” information (section 3.2.A.2). (EU B.II.h.1)

major SAP Nr. minor

SAP Nr.











CEP/TSESubmission of new or updated Ph. Eur. certificates of suitability or deletion of Ph. Eur. certificates of suitability for active pharmaceutical ingredients, for starting materials/reagents/intermediates used in the manufacturing process of the active pharmaceutical ingredient, and for excipients (EU B.III.1).

major SAP Nr. minor

SAP Nr.











Monographs (M)Change to comply with Ph. Eur., Pharmacopoeia Helvetica or with another recognized national pharmacopoeia. (EU B.III.2)











Measuring or administration device (MV)Change of a measuring or administration device. (EU B.IV.1)

major SAP Nr. minor

SAP Nr.











Specification of a measuring or administration device (SPMV)Change in specification parameters and/or limits of a measuring or administration device for veterinary medicinal products. (EU B.IV.2)

major SAP Nr. minor SAP Nr.Veterinary medicines ☐ (2240) ☐ (2410)










Test procedures of a measuring or administration device (PMMV)Change in test procedures of a measuring or administration device for veterinary medicinal product. (EU B.IV.3)

minor SAP Nr.Veterinary medicines ☐ (2411)










PMFInclusion of a new or amended Plasma Master File (PMF) in the marketing authorisation dossier of a medicinal product. (EU B.V.a.1)

major SAP Nr. minor SAP Nr.Human Medicines ☐ (2241) ☐ (2412)










VAMFInclusion of a new or amended Vaccine Antigen Master File (VAMF) in the marketing authorisation dossier of a medicinal product. (EU B.V.a.2)

major SAP Nr.Human Medicines ☐ (2242)










OTHER CHANGES (Q)Other quality changes.

major SAP Nr. minor SAP Nr.Human Medicines ☐ (2243) ☐ (2413)Veterinary medicines ☐ (2247) ☐ (2417)Complementary and herbal medicines ☐ (2244) ☐ (2414)Allergens ☐ (2245) ☐ (2415)Radiopharmaceuticals ☐ (2246) ☐ (2416)Advanced therapy products ☐ ☐










Change history

Version Valid and binding as of:

Modified without version change

Description, comments (by author) Author’s initials

14.08.2017 Section advanced therapy products has been inserted cis

18.05.15 Page 50 , CEP/TSE: the wording has been edited. cis

26.03.15 Document technically adapted for internet publication. sel

08 01.01.15Page 1: Information on handling quality variations requiring approval added and existing administrative details updated.

wer, its

17.11.14Telephone and fax number in the footer updated, new change history inserted in the document, document name modified in the header.

cis

07 19.05.14 Adaptation to the Guidance document Formal requirements cis

QM-Ident: ZL302_00_001e_FO


ZL302_00_001e_FO Quality variation requiring approval · Web viewIn order to levy fees...

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