Quality Systems, Data Integrity among Most Frequent Problems Cited by MHRA


Pharmaceutical manufacturers around the world, including CMOs, subject to inspection by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) can expect to see a more intense focus on quality systems and data integrity.

Problems related to quality systems are the most prevalent observations during inspections of pharmaceutical manufacturers, including CMOs, in the UK, according to a recent report by the Medicines and Healthcare Products Regulatory Agency (MHRA). The report was based on findings during 2013 inspections.

Over the past five years, the agency reported, the most frequently noted issues have remained consistent, except for contamination problems, which have increased. Also over the last five years, the number of major deficiencies per inspection remained relatively constant, and the number of critical deficiencies remained constant until 2013, when an increase was noted, due to a cluster of data integrity issues.

Review of the data included in the report will affect areas that receive the greatest inspector attention during coming audits, an MHRA spokesperson said.

“[Inspectors] will look at the whole of GMP compliance, of course,” he added. “But there are areas of general concern that will receive more focus.”

Darrell Bledsoe, a former FDA investigator who participated in some joint inspections with EU officials, including officials from MHRA, agreed, saying “Inspectors are very good at identifying trends and homing in on areas of weakness. It’s well-established that [they] will focus on quality systems anyway, and data integrity has proven to be a big deal lately, particularly in areas like India and Asia.”

The US FDA has long shared inspectional information with the UK and other nations in the EU, and vice versa, Bledsoe added, so findings by one regulatory agency often are shared with and affect activities by those in other nations.

The MHRA review covered 630 GMP inspections carried out in 2013, 216 of which included major or critical deficiency observations. The table below highlights the top five most common deficiencies reported over the last five years.

Quality Systems Blog Post

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Lisa serves as the Managing Editor at PharmSource. She holds a BS degree in journalism from Radford University, and has over 20 years of experience in editing, writing and managing newsletters and other print media, including B2B publications related to industries including science, pharmaceuticals, biologics and medical devices.

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