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Update 6/2021 is live!
Dear Member,
If it is not documented, it was not done.” You have certainly come across this sentence, haven’t you? Good Documentation Practice goes hand in hand with Good Manufacturing Practice or rather: Without Good Documentation Practice GMP is not even conceivable! In this update, we look at this important topic from several perspectives that concern all of you!
Chapter 15.A starts with the regulatory requirements for documentation. Ministerial Pharmaceutical Director Michael Hiob guides you safely through the jungle of European requirements.
In chapter 15.B, Christine Oechslein and Cornelia Wawretschek highlight all you need to know for the practical implementation of the regulatory requirements.
Electronic document management systems (eDMS) are dealt with in chapter 15.G. You’ll learn what requirements you should place on an eDMS, what to consider when selecting a suitable eDMS and how to successfully implement such a system.
Chapter 15.I focuses on one of the most important aspects of the data life cycle: GMP-compliant archiving.

From the regulatory side two new guidelines on data integrity ideally complement chapter 15: The WHO and the PIC/S, both offer a practical approach in their documents, covering all aspects to be considered for handling data in the GMP/GDP field.
And to put it briefly, the revised EMA Q&A on nitrosamines, the revised FDA Q&A on biosimilars and a new guideline describing the WHO-approach for water for pharmaceutical use were also added to the knowledge portal.

Finally, a short prospect for 2022:
We have heard that the release of Annex 1 on sterile manufacturing is almost around the corner, which apparently holds true for the new Annex 21 on import of medicinal products as well. As always, we will keep a close eye on the developments.

For the time being, we wish you a successful finish of the year and a peaceful transition into 2022 – but most of all: Stay healthy!

Best regards,
Your Editorial Team

The GMP Compliance Adviser in 2021

This year we provided you with 6 Updates including

  • 16 new practice chapters
  • 12 updated practice chapters
  • 5 new guidances
  • 28 updated guidances

  • 5 new authors share their practical expertise with you

GMP in Practice

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