Revised Annex 1 now in effect - how has the industry implemented the new regulations?

Wolfgang Weikmann

After a complete revision of the EU GMP Annex 1, the final version was published in August 2022 and became effective just a few days ago on August 25, 2023. The new regulation includes aspects that affect Vetter’s business operations. Wolfgang Weikmann, Senior Vice President Quality at Vetter, provides insight into how the fill-finish service provider has addressed the new requirements defined in the revised regulation.

How has Vetter used the one-year period that was given to the pharmaceutical industry to comply with the new Annex 1?

The given period was only ‘one chapter’ in dealing with the revised Annex 1. As a leading CDMO for the production of sterile injectable drug products, we have been following the status and development of the EU GMP Annex 1 for several years since the revision was announced. Vetter has been involved in the reviewing, evaluating and commenting on the published draft versions of the regulation.

Recognizing the importance of the EU GMP Annex 1 for our industry, Vetter has already established a holistic and cross-functional Annex 1 Program in 2021.

Can you tell us more about Vetter’s comprehensive Annex 1 Program?

The EU GMP Annex 1 is considered to be one of the most important regulations for the manufacture of sterile pharmaceutical drug products and we are aware that our compliance with this regulation is of utmost importance for our customers and the manufacturing of their drug products.

The Annex 1 Program was established in order to coordinate and bundle the numerous activities applicable to the various Vetter sites and to address this topical subject in a holistic and objective-oriented manner.

A key task within our Annex 1 Program was the timely launch of an evaluation project as soon as the final version of the revised EU GMP Annex 1 was published. Subject matter experts carefully reviewed the extensive document and compared it to the latest draft version, evaluated the compliance of Vetter’s quality system and processes with the outlined new requirements, and defined additional actions to be integrated into the already existing projects within Vetter’s Annex 1 Program.

What was the outcome of this assessment?

Vetter has a successful track record. Our experience in dealing with various international regulatory requirements over the past decades gives us confidence in our overall manufacturing processes. And the evaluation of the new EU GMP Annex 1 once again confirmed the high robustness, consistency and quality of Vetter’s processes and systems.

The review of the total of 297 paragraphs of the new EU GMP Annex 1 showed that more than 190 paragraphs were either already fulfilled by our established Quality Management System or required only minor adaptations in our documentation. In addition, it also revealed that 35 paragraphs have no relevance to Vetter. Only about 70 paragraphs were identified that required varying degrees of further attention within the organization.

How did you proceed further?

We have taken initiatives within our Annex 1 Program. Over the past few months, we have been working on adapting our documentation accordingly. In addition, the identified action areas have been incorporated and are being managed through various internal projects.

In these projects, interdisciplinary teams from all our sites have worked intensively with the respective subject matter experts and Quality Assurance representatives. These teams drove the implementation of the measures required for our manufacturing processes. They evaluated our operations, consulted with service providers and suppliers, and developed and launched optimization measures.

Did you also inform your customers about the results of the review?

Yes, of course we did. Communication with customers is crucial for an industry-wide topic as important as the EU GMP Annex 1. Not only did we inform our customers about the results of the review, but we also communicated regularly on ongoing activities and provided updates on the new regulatory requirements through various channels.

Now that the Annex 1 is ‘live’ – what is the status at Vetter and what happens next?

The revised EU GMP Annex 1 contains many aspects that need to be considered in our operations. The majority of the requirements have been successfully integrated into our manufacturing processes. Some activities are ongoing but require additional time for full and effective implementation. Timelines for these activities have been defined and are being closely monitored. In addition, comprehensive mitigation strategies have been developed. 

Let me conclude this interview with the following: At Vetter, we will continue to optimize our systems and processes to enable manufacturing of consistently high quality and compliance with international regulations.

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