MHRA: Feedback from GMP inspections

To assist pharmaceutical manufacturers and distributors to understand the areas where good manufacturing practice (GMP) inspectors have found compliance problems during GMP inspections in the UK and overseas, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) GMP Inspectorate has issued data, during October 2019, relating to common deficiencies from previous GMP inspections conducted during 2018.

While the anonymised raw data provided by the GMP Inspectorate is of general interest, additional analysis is required to draw meaningful inferences. In this article, the data has been reviewed and presented, in order to obtain an overview of key trends.

These trends have bene captured in an article, written by Tim Sandle for GMP Review. The reference is:

Sandle, T. (2019) MHRA: Feedback from GMP inspections, GMP Review, 18 (3): 8-14

For further details, please contact Tim Sandle.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)