New EU GMP Annex 1 – Implications for QRM application

Written by Alessio Rosati | Mar 2, 2021 10:00:00 AM

The issues exposed in this article were discussed in “Risk Based approach to Qualification Activities” free Webinar by PQE, on April 20^th. Register now to watch it on-demand (coming soon).

Introduction

After a long period of preparation and review, the new revision of EU GMP Annex 1 is about to be issued. An outstanding amount of new requirements, recommendations and detailed specifications are included in the Annex 1 draft 2020, altogether implying that sterile manufacturers will have to focus efforts, knowledge and time in getting full compliance for their products and processes.

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New EU GMP Annex 1 – Implications for QRM application

The issues exposed in this article were discussed in “Risk Based approach to Qualification Activities” free Webinar by PQE, on April 20th. Register now to watch it on-demand (coming soon).

Introduction

The issues exposed in this article were discussed in “Risk Based approach to Qualification Activities” free Webinar by PQE, on April 20^th. Register now to watch it on-demand (coming soon).