EU GMP Guide: New concept papers for revision of Annex 4 and Annex 5 for VMPs

The European Medicines Agency has published two new concept papers for Annex 4 and Annex 5 for veterinary medicinal products on 11 November 2021:

• Concept paper on the revision of annex 4 of the guidelines on good manufacturing practice – manufacture of veterinary medicinal products other than immunologicals
• Concept paper on the revision of annex 5 of the guidelines on good manufacturing practice for medicinal products – manufacture of immunological veterinary medicinal products

Both documents were originally issued in 1992 and have not been revised since then. With significant changes in GMP and in veterinary product manufacture and technologies a revision is hence overdue. Especially following the release of the technical requirements of ICH Q8, Q9, Q10 and Q11 there has been extensive technology progress and additionally, progress in the development of new products, e.g., ATMPs, cell products, or tissue engineered products. Along with this goes the separation of the EU GMP Guide in 2005, in GMP for medicinal products (Part I) and for active substances (Part II) which is also not reflected in the current annexes, so far.

What is planned?

• A harmonisation with the current chapters 3 and 5 to provide improved guidance on the prevention of cross contamination and introduce a quality risk management approach.
• Adaptations for the manufacture of some specific veterinary medicinal products
• A harmonisation with chapter 1, 4 and 6 and annexes 11, 15 and 19, as well as international pharmacopeia and the above-mentioned ICH documents
• A reflection of the new EU Veterinary Medicines Regulation (Regulation (EU) 2019/6)

For Annex 4 manufacture of veterinary medicinal products other than immunologicals:

• Consider the technological progress, to cover the manufacture of dosage forms which are specific to the veterinary sector
• Extend the scope to the manufacture of veterinary medicinal products used for veterinary clinical trial when required by national law
• State its applicability to GMP Guidelines Part I, only.

For Annex 5 manufacture of immunological veterinary medicinal products:

• Extend the solely focus on the manufacture of immunological VMPs to other veterinary biological products
• Provide supplements to GMP Part I and GMP Part II
• Clarify to what extend principles of Q8, 9 and 10 and the VICH guidelines should be followed regarding design, implementation of facilities, equipment, and processes
• Make clear its applicability to both medicinal product manufacturers and biological substance manufacturers.

Both papers are currently open for stakeholder consultation. Comments should be sent to ADM-GMDP@ema.europa.eu until 9 January 2022 using this template. The proposed date for the release of the draft guidelines is March 2023. A drafting group will be established by GMP/GDP Inspectors Working Group and the PIC/S WG on VMP representing the PIC/S committee with a rapporteur and supporting experts from other EU member regulatory authorities and from non-EU PIC/S participating authorities.

Source:

EMA: Human regulatory, GMP/GDP IWG