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9 Sep 2021

Sterile manufacturing Annex 1 amendments: what, why and how explained

In January 2020 the European Commission published some proposed significant revisions to Annex 1, the EU’s good manufacturing practice (GMP) guide for the manufacture of sterile products. In the following three-month consultation period, affected organisations and stakeholders from over 70 different countries submitted more than 2,000 comments to the proposed update.

In this article Dr. Thomas Becker, Director Quality at Recipharm in Wasserburg, discusses the key changes to the guide and the impact it will have on companies responsible for the manufacture of sterile products as the industry continues to work to meet the industry’s changing requirements and overcome reoccurring challenges in the supply chain.

Mentioned Companies
Recipharm AB
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