Your Complete Source for EU GMP Annex 1 

The European Commission very recently released their EU GMP Annex 1: 2017 draft for review and comment. Our experts have reviewed this document carefully and are ready to share their insights with you. 

Get a summary of the EU GMP Annex 1 Draft Revisions by reading the paper below or watching the recorded webinar at the right. 

Have a question? Submit your own question for one of our experts and they'll get back to you with an answer. 

Our Advisory and Training Services are also available to you - to support you at every step of your process, whether it be non-compliance issues, setting up a new process, or training employees. Our team has the background and education you need. 

Knowledge / Papers

The New EU GMP Annex 1 Draft: Impact on Environmental Monitoring Programs

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. 

read all

The New EU GMP Annex 1 Revision 2017 Comments from Industry Experts

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.

read all

Confused about the Annex 1 draft proposed changes how they might affect you?  

Our experts answer over 40 common questions about the new draft.  If you can’t find the answer to your question, the contact information for an Annex 1 expert is included at the end of the paper.  

read all

EU GMP Annex 1 Compliant Products
 

 

BioLaz® Real-Time Microbial Monitor

BioLaz® Real-Time Microbial Monitor

Provides real-time detection of biological organisms in controlled environments used for the manufacture of sterile products.

BioCapt® Single-Use Microbial Impactor

BioCapt® Single-Use Microbial Impactor

This innovative approach provides 24 hr sampling, and minimizes false positives, resulting in a decrease in investigations.

Lasair® III Airborne Portable Particle Counter

Lasair® III Airborne Portable Particle Counter

Sets the standard for portable aerosol particle counters and meets the requirements of ISO 14644-1:2015 and  ISO 21501-4

FacilityPro® Environmental Monitoring

FacilityPro® Environmental Monitoring

Industrial control systems assure data integrity, process automation, simpicity of use, and data integration. 

Get a Quote

Upcoming Webinar

The New EU GMP Annex 1 Revisions 2017: Review, Insights, and Feedback

Attend this webinar to:

  • Get an expert review of Annex 1
  • Get insights and feedback from experts on the Annex 1 draft
  • Submit your comments and feedback (we will compile for the commission)
  • Learn what the updated Annex 1 might mean to you 

What's Included?

  • Certificate of Attendance
  • Summary of Experts' Comments
  • Recorded Webinar

On Demand Webinar

The New EU GMP Annex 1 Revisions 2017: Review, Insights, and Feedback

PRESENTERS: Gilberto Dalmaso, PhD - Senior Advisor and Pharma Customer Advisory Team Manager
Frank Panofen, PhD - Sterility Assurance/Microbiology Product Line Manager
Daniele Pandolfi - Aerosol, Life Sciences Product Line Manager

Download this webinar to learn about the new draft of the EU GMP Annex 1:2017 and what these changes might mean for you.

Download Now

Ask a Question

EU GMP Annex 1

Do you have an EU GMP Annex1 question? Read our frequently asked questions below or submit your specific question and one of our experts will respond shortly.