Your Complete Source for EU GMP Annex 1 Insights & Updates
The European Commission released their EU GMP Annex 1: 2017 draft for review and comment. Our experts have reviewed this document carefully and have shared their insights with you.
Here are some quick video snippets on single topics covered by Annex 1 Rev 12:
- Annex 1 2020 Update: Continuous Viable Monitoring
- Annex 1 2020 Alternative Micro Methods and Rapid microbial
- Single Use Considerations and a solution
- Cleaning & Disinfection: What you need to know
Stay tuned for more spinets or get a summary of the EU GMP Annex 1 Draft Revisions by reading the paper below or watching the on-demand webinar at the right. We also have FAQs with answers below. Also, scroll to the bottom for some of our GMP compliant products.
Knowledge / Papers
On December 20th, after intensive research and debates, the draft for a Revision of ANNEX 1 (“Manufacture of Sterile Medicinal Products”) of the EU Guideline for GOOD MANUFACTURING PRACTICE for drug products and drug substances was published for public comment. This updated document will set a milestone for adjustments needed within European agencies overseeing drug products regulatory applications.
The updated EU GMP Annex 1 Draft was released for public comment in December 2017, and the industry experts at Particle Measuring Systems have shared their response on the revision.
EU GMP Annex 1 Compliant Products
Innovative replacement for settle plates, provides 2 hr sampling, and minimizes false positives, resulting in a decrease in investigations.
Industrial control systems assure data integrity, process automation, simpicity of use, and data integration.
The innovative microbial air sampler. ISO 14698:2003 compliant
Creates a complete contamination monitoring solution for pharmaceutical manufacturers.