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Principle General principles as applied to the manufacture of sterile products. Scope Includes additional areas (other than sterile products) where the general principles of the annex can be applied.

1 1 Annex 1 : Manufacture of Sterile Products 2 3 Document map Section Number General overview 1.

Proposed date for release of draft guideline is October 2015. The original version was partially revised in 1996, 20.

Annex 1, the primary GMP guidance on sterile manufacturing for Europe and PIC/S member countries is ‘ all set’ for revision.

This webinar will outline a holistic approach to ensure continued compliance, taking into account the expected changes, including the need for EM.

The recent 2020 draft of EU GMP Annex 1, which regulates the manufacture, control and release of sterile pharmaceutical products in the EU, signals that there are comprehensive changes to come.