MHRA GMP Report: Quality Systems Still a Top Concern in 2016

April 19, 2017

The number of deficiencies found in foreign and UK-based facilities increased in 2016.

The Medicines & Healthcare products Regulatory Agency (MHRA) released a report on Apr. 19, 2017 detailing the inspection deficiencies that were most common in 2016. Total inspections were up, rising from 303 in 2015 to 324 in 2016. The number one, most-cited deficiency in 2016 was related to quality issues.

Quality was also the number one concern in 2015, but in 2016, sterility assurance and production followed quality as the most-often cited insufficiencies, whereas in 2015, documents and complaints, as well as recalls, were among the top three cited problems.

Deficiencies related to incident investigation and corrective action and preventive action (CAPA) implementation included insufficient information on deviation reports, inadequate measurement of impact of a deviation, poor tracking of previous deviations, and insufficient procedures to record and identify root causes. Overdue CAPAs and the absence of required CAPAs were among the most conspicuous problems related to facility inspections.

The report also listed the specific deficiencies due to lack of senior management oversight on effective implementation of pharmaceutical quality system and continuous improvement, the management of changes, product quality review, monitoring regulatory updates, staff training, products that were returned, failure to minimize contamination, problems with premises and equipment, and inadequate temperature and document control.

Also cited were issues with integrity of data, the management of materials, quality control laboratories, out-of-specification investigations, the handling of complaints and product recalls, stability studies, the management of outsourced activities, media fill, controls for cleaning, gaps related to computerized programs and data, and increased risks of microbial contamination.

Source: MHRA