EU GMP Annex 1

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.

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

Our experts answer over 40 common questions including:

- During cleanroom classification, is it mandatory to monitor viable and non-viable counts simultaneously?
- Can you choose not to use one of the microbiological sampling methods for qualification of a classified area?
- Does the removal of the 5 micron particle size from ISO 14644 mean the qualification time for Grade A and B will be vastly reduced?
- Have particle sizes greater than 5.0 been removed as a requirement of Grade A or B monitoring?

Get answers to these and other questions by filling out the form and downloading the paper. 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. 

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

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