Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

Menu

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
My View
Tags:
Manufacturing Quality Europe

EU GMP Annex I Is A Top Priority For EMA While Industry Has Lingering Concerns

  • News

Executive Summary

Questions about contamination control strategy raised as European Medicines Agency makes EU GMP Annex I revision a top priority in its 2021 work plan.

You may also be interested in...



Here At Last: New EU Annex On Sterile Drug Manufacturing Targets Contamination & Risk

Following two public consultations and many thousands of comments, the revised GMP Annex 1 has finally been published.

Final Revisions Should Ease Global Use Of EU GMP Annex I Sterile Drugs Guidance, Associations Say

Inter-associations working group suggests changes to the EU GMP Annex I revision to make it easier to understand by health authorities worldwide; the groups point out that the annex will be used globally and not just in Europe.

EU GMP Annex I Proposal Would Maintain PUPSIT, Relax WFI Restrictions

The pharmaceutical industry would lose bid to eliminate PUPSIT but win relaxed WFI in proposed EU GMP Annex I revision.

Table

View full table

Topics

Tags:
Manufacturing Quality Europe
Latest Headlines

New EU Filings

WHO Examines Ethical Criteria For Human Challenge Trials Ahead Of Next Health Emergency

Post-Brexit UK Risks Being ‘Left Out In The Cold’ As EU Coordinates Action On Shortages

Gene Therapy: Pediatric Development Could Start Sooner Than Sponsors Think – FDA OTP Director

See All
UsernamePublicRestriction

Register

PS144038

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By