The agency broke down its inspection work over the last five years and found that the ratio of major deficiencies raised per inspection has remained relatively constant, and even decreased since 2009. But the ratio of critical deficiencies remained constant until 2013, when the agency reported “a cluster of data integrity issues with potential impact to public health.”
Data integrity issues -- both as a result of bad practice and to “a significantly lesser extent intentional fraud” -- have been observed by the agency across all locations and sectors of the industry. “There will therefore be a focus on this area during inspections in the near future,” the agency says.
The MHRA also observed that the relative number of critical deficiencies raised per inspection in a given continent is higher in Asia than the other continents.
In addition, the most frequently encountered defect categories raised over the previous five years have remained relatively consistent, though there has been a significant increase in physical or chemical contaminations.
“There has been a general trend towards higher potency active substances, therefore increasing the potential for a contamination event to have a greater impact,” the MHRA says.
The analysis observed 630 GMP inspections in 2013, 216 of which resulted in major or critical deficiencies and 174 of those were in the UK while 42 were overseas.
In offering examples of quality system deficiencies, the MHRA cited the following:
- No self-inspections carried out in the previous year, nor was there a programme established for the current year;
- Quality system was not being maintained in that Product Quality Reviews had not been completed during the required period and a significant number of SOPs were past their review date, among other things; and
- The laboratory pharmaceutical quality system was silent with respect to stability sample management.