CDMO Insights

Well prepared for the revision of the EU GMP Annex 1

cleanroom employee

The Annex 1 of the EU GMP Guide "Manufacture of Sterile Medicinal Products" is considered the most important European regulatory standard for the manufacture of sterile pharmaceutical products.

It is undergoing a complete overhaul in collaboration with the EMAWHO and the PIC/S*. One of the most extensive revisions since its implementation in the 1970s. A draft of the ‘new Annex 1’, published in December 2017 and revised again in February 2020 made it clear that the guideline will not only be updated with some parts completely rewritten, but also more detailed, stricter and with additional content.

Regulatory requirements in the pharmaceutical industry are expected to increase further. The changes made in the revision of Annex 1 show, that developments in manufacturing and testing as well as quality risk management principles, are now more extensively taken into account.

Katja Kotter, Vice President Regulatory Affairs/ Quality Compliance, Vetter

Within Vetter an interdisciplinary team has been monitoring the development of Annex 1 very closely. After thorough evaluation internally, comments to EMA were provided via ISPE**. Within ISPE, Vetter actively participated in the consolidation of the industry comments and also contributed to the correspondence by the group of industry associations.

Furthermore, Vetter participated in conferences, webcasts and panel discussions on the topic. This was helpful for the team to understand the way of thinking regarding the requirements put forward by EMA, PIC/S and WHO and to assess the implications once the final version is published.

Challenges for the industry 

With the draft Annex 1 industry experts see changes especially in the areas of quality risk management, contamination control strategies and environmental and process monitoring. 

The Vetter team evaluated the requirements of the draft Annex 1 (2020 version) thoroughly. The current status of activities is as follows:

  • Implementation of a contamination control strategy that has already been successfully inspected
  • Initiation of projects to evaluate possible implementation strategies in case the requirements will be part of the final Annex 1
  • Initiation of projects to improve the compliance of the Vetter systems to the new requirements (e.g. environmental monitoring, aseptic process simulations)
  • Definition of a project organization that will allow a rapid implementation of the defined measures of the Annex 1 once it becomes effective

Minimizing the risk of microbial, particulate and pyrogen contamination and therefore ensuring the sterility of the manufactured products is one of the focus topics of the outlined draft of the EU GMP Annex 1. At Vetter, we have been expecting this industry trend and have already a comprehensive contamination control strategy in place.

Julia Allgaier, Lead Expert Contamination Control, Vetter

Vetter is ready for Annex 1 

As one of the world's leading pharmaceutical service providers for sterile injection systems the company is well-positioned to address the topics outlined within the draft paper. Vetter will continue to actively track the development of Annex 1 to ensure continued compliance of our systems and processes.

 

Footnotes:

*EMA: European Medicines Agency, WHO: World Health Organization, PIC/S: Pharmaceutical Inspection Co-operation Scheme

**ISPE: International Society for Pharmaceutical Engineering