GMP NEWS 2022

In the GMP rules there are many undefined terms, such as regular, adequate, etc. Inspection reports that interpret these undefined legal terms sometimes help here. In this case it is about insufficient process validation. What happened?

After more than five years and two public drafts for comment, the European Commission this week published the final version of the new EU GMP Annex 1 "Manufacture of Sterile Medicinal Products". Learn more about deadlines and changes compared to the 2nd draft version for comment from 2020.

The U.S. Food and Drug Administration (FDA) issued a Form 483 to India-based manufacturer Sun Pharmaceutical following an inspection of its Mohali facility in August 2022. Among other observations, it came out that employees responsible for collecting samples did not enter the buildings where the samples were documented to have been collected. In other cases, based on building access records, the employee was in a different building at the time the sample was documented to have been collected.

In the follow-up to the pandemic situation, the FDA is still reviewing the manufacture and importation of hand sanitizers and identifying potentially critical hand sanitizers. This is shown by the warning letter issued to Guangzhou Orchard Aromatherapy & Skin Care Co.

When conducting GDP audits, it can be helpful to work with question lists. We have compiled typical questions for ocean freight operations.

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Amazon for selling unapproved drugs for mole and skin tag removal that have not been evaluated by the FDA for safety, effectiveness or quality. Amazon has 15 working days to respond and explain the specific steps that were taken to address the violations. Otherwise, legal action may result.

In May, the Chinese National Medical Products Administration (NMPA) published their new Annex 13 "GMP for Investigational Medicinal Products (IMPs)", which was incorporated into the Chinese GMP guidelines on July 01, 2022.

Since the end of last year, the ICH Q9 document on quality risk management has been in stage 2 of the ICH process for publishing ICH documents as a draft revision 1. Now, the draft document has also been published by the FDA on its website and is available for comments.  

EMA's Question and Answer document on nitrosamine impurities is addressed to marketing authorisation holders. This document describes the approach to review the manufacturing processes for chemically-synthesised and biological medicinal products and to do the risk assessments accordingly. Read more about which new deadlines for variations have to be observed and what has changed in the forms.