GMP News - Pharmaceutical Development / Clinical Trials / GCP

Microbiological testing of topical drug products to prove compliance with the specifications prior to release and correct labelling is mandatory for products applied to the skin. Find out, what GMP violations regarding the manufacturing, testing and labelling FDA inspectors found during an inspection.

The European Medicines Agency (EMA) published the first revision on their Guideline on safety and efficacy follow-up and risk management of Advanced Therapy Medicinal Products, considering the experiences since the first adopted version.

Recently a draft monograph on PAT has been published for comment in Pharmeuropa. Read more about Ph. Eur. chapter 5.25. Process Analytical Technology.

The EMA issued the draft of the Guideline ICH Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management and its Annexes for commenting.

The final "Detailed Commission guidelines on GMP for IMPs for human use" have been published in Annex 13 of the EU GMP-Guidelines. What has changed in comparison to the previous Annex 13 in regard to complaints and recalls?

The annual report 2016 of the GCP Inspectors Working Group (IWG) has been published. According to the report EU inspectors have found more than 1000 clinical trial deficiencies in 2016. Read more about the Annual report of the Good Clinical Practice Inspectors Working Group 2016.

The Detailed Commission Guidelines on GMP for IMPs have now been published as final in Annex 13 in EudraLex Volume 4.