Annex 1: What's new? – A Comparison from Draft to Final
Login
Pages
1 Excel and 1 PDF file, in total 337
Edition
3rd edition, 2022
Product type
E-book
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.
The comparison shows you where action is needed.
€99.00
net excl. VATProduct information
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
Do You Have Questions?
Talk to our customer advisors
Do you have any questions about our products and services? We are here to help.