UPDATE: Second Stakeholders’ Consultation on the Revision of Annex 1

February 21, 2020

The second targeted stakeholders’ consultation on the revision of Annex 1, on the manufacturing of sterile medicinal products, of Eudralex Volume 4

Tablets

Period of Consultation: 20 February 2020 to 20 May 2020

Due to widespread interest from the industry following the first targeted consultation, and because of substantial modifications introduced in several sections, it was agreed to engage with stakeholders on a second targeted consultation on the updated draft guidance (version 12) focused on the sections and/or significantly modified paragraphs that raised most concerns.

Acknowledgement

In order to maintain the global alignment of standards, achieving assurance for the highest quality at the same time, the document will be, in parallel, subject to a second targeted consultation by WHO and PIC/S.

Targeted stakeholders

The following organizations representing relevant stakeholders have accepted taking part in the second consultation and have agreed to receive, compile, and send all comments to the European Commission:

  • A3P (Association for Products Propres and Parentals)
  • AESGP (Association of the European Self-Medication Industry)
  • AnimalhealthEurope
  • APIC (Active Pharmaceutical Ingredient Committee)
  • EAEPC (European Association of Euro-Pharmaceutical Companies)
  • ECA (European Compliance Academy)
  • EFPIA (European Federation of Pharmaceutical Industries and Associations)
  • EGGVP (European Group for Generic Veterinary Products)
  • EIPG (European Industrial Pharmacists Group)
  • GIRP (European Healthcare Distribution Association)
  • ISPE (International Society for Pharmaceutical Engineering)
  • Medicines for Europe
  • PDA (Parenteral Drug Association)
  • PHSS (Pharmaceutical & Healthcare Sciences Society)
  • EQPA (European Qualified Person Association)Vaccines Europe

Reference:
https://www.gmp-compliance.org/files/guidemgr/2020_annex1ps_sterile_medicinal_products_en.pdf

About the Author:

Henchion, JohnJohn Henchion

John has more than 23 years of experience providing technical and consulting services in cGMP pharmaceutical and biotechnical environments. John is an experienced QP with several years’ experience releasing both commercial and clinical material to market. John is a Quality Systems SME.  He understands FDA and EU regulations, regulatory guidance documents, and ICH guidelines and has applied the knowledge to develop risk based approaches for several applications. John has significant experience in GMP/ISO compliance auditing of manufacturing facilities and supply chain.