PDA have announced the formation of the Annex 1 Implementation Interest Group, which will begin meeting in February. The focus of this limited-duration Interest Group is to support the industry as it continues to work through the implementation challenges presented by the significant 2022 revision to EU GMP Annex 1: Manufacture of Sterile Products. PDA is encouraging those who want to participate, learn from, and contribute to the new interest group to sign up here.

Industry experts leading the Interest Group will be Marcia Baroni, Emergent BioSolutions; Rebecca Brewer, Quality Executive Partners; Gabriele Gori, Thermo Fisher Scientific; and Stephen Langille, ValSource.

“We at PDA are very excited to launch this new Interest Group that will provide additional support to industry in this very critical area,” said Glenn Wright, the incoming President and CEO of PDA. “We are equally excited about having such a strong group of industry experts leading it. Providing a framework for industry members to connect, have open discussions and share information on such critical topics continues to be at the center of what we do at PDA.”

PDA has been actively involved in providing comments and recommendations to the regulators on EU Annex 1 revisions for over a decade. In 2023 PDA will continue to offer its very successful Annex 1 Workshop series, as well as provide presentations at other PDA Conferences to help industry as they work to implement the required changes.

The latest revision of the EU GMP Annex 1, released by the European Commission on August 22, 2022, enlarged the document from 16 to 58 pages with additional detail in most areas and included a number of challenging new expectations that industry is currently working to implement. The majority of these must be implemented by industry by August 25, 2023. Through the interest group, workshops, presentations, and articles, PDA will continue to lead the way in helping industry as they work through these challenges

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