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Annex 1: What's new? – A Comparison from Draft to Final

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The final version of Annex 1 (2022) of the EU GMP Guide, titled "Manufacture of Sterile Medicinal Products", has kept many responsible persons busy.

Do you also ask yourself:

  • What has been changed?
  • Am I well prepared?
  • What action do I have to take?

Also included in the comparison file are:

  • A comparison of the currently still valid version from 2008 with the draft document of 2017
  • A comparison of the draft documents from 2017 to 2020

This makes it easy for you to track all the development steps that led to the final version in 2022. A criticality index (1–3) is used to evaluate the various changes.

With this download, you receive the comparison not only as a PDF but also as an editable MS Excel file. You can use the format that helps you best.

Target Group

  • Manufacturers of sterile and aseptic pharmaceuticals
  • Quality assurance
  • Production
  • External service providers
  • Consultants

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GMP Compliance Adviser | Named User Licence | 12M

GMP Compliance Adviser | Named User Licence | 12M

The GMP Compliance Adviser is an online publication that covers all aspects of Good Manufacturing Practice (GMP) in one source.In the GMP Compliance Adviser you’ll find: GMP in Practice This part contains 21 chapters with GMP expert knowledge to base your decisions upon. It provides practical assistance with checklists, templates and SOP examples. It is written by more than 80 authors with hands-on experience directly linked to the industry. The individual chapters describe the different aspects of GMP in clear language. Technical, organizational and procedural aspects are covered.More than 700 checklists, templates and examples of standard operation procedures taken directly out of practice help you in understanding the GMP requirements.GMP RegulationsThese chapters cover the most important GMP regulations from Europe and the United States (CFR and FDA), but also PIC/S, ICH, WHO and many more.  Sample Documents In addition, the GMP Compliance Adviser contains many sample documents and practical examples that you can use.

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