Skip to main content Skip to search Skip to main navigation

Order now: Comparative document to the final Annex 1: What's new?

>>> Pre-order Now!

The GMP-Verlag offers a comparison document for download for this final version.

The draft of Annex 1 "Sterile and aseptic production" of the EU GMP guide kept many of those responsible in the pharmaceutical industry busy. On August 25, 2022, the long-awaited final version was released.

Also ask yourself the following questions:

  • What has changed?
  • Am I prepared for this?
  • What should I do now?

This download will help you answer these questions.

The EU GMP Guideline Annex 1 "Manufacture of sterile medicinal products" in a comparison of the final version from 2022 with the draft version from February 2020.

  • Download
  • 1 Excel and 1 PDF file

 

>>> Pre-oder now!

Meet the GMP Compliance Adviser

The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business. 

The demo access is non-binding and ends automatically.

Test it now for free

You may also be Interested in the Following Articles:

What are the quality requirements for pharmaceutical gases?

What are the quality requirements for pharmaceutical gases?

You can view the answer here:
Read more
EMA: Update on the Guideline “Stability Testing for Variations”

EMA: Update on the Guideline “Stability Testing for Variations”

The EMA has updated the guideline on stability testing for variations (Revision 3, applicable from 15 January 2026).
Read more
EU: Proposal for Simplification of Medical Device Rules

EU: Proposal for Simplification of Medical Device Rules

The European Commission has proposed targeted reforms to simplify the Medical Device Regulation (Regulation (EU) 2017/745, MDR) and the In Vitro Diagnostic Regulation (Regulation (EU) 2017/746, IVDR) and to address structural implementation challenges.
Read more
EU: Proposal for a European Biotech Act

EU: Proposal for a European Biotech Act

The European Commission has presented a proposal for a European Biotech Act aimed at strengthening Europe’s biotechnology potential and accelerating the translation of innovation from the laboratory to the market.

Read more
EMA: Concept Paper for the Revision of Annex 3 on Radiopharmaceuticals

EMA: Concept Paper for the Revision of Annex 3 on Radiopharmaceuticals

The EMA has published a concept paper outlining a future revision of Annex 3 (Manufacture of Radiopharmaceuticals) of the EU GMP Guidelines. The paper was developed in collaboration with PIC/S and adopted by the GMDP Inspectors Working Group (IWG) at its November meeting.

Read more
EMA: Q&A on QP Certification Without Physical EU Import

EMA: Q&A on QP Certification Without Physical EU Import

The EMA has published a new Q&A addressing QP certification for batches that are neither manufactured within the EU/EEA nor intended for the EU/EEA market, and that are not physically imported into the EU/EEA.

Read more
Previous
Next