The UK drug regulator reported the increase in sterility assurance issues last week, citing instances of unsanitary handling, lack of operator hand washing during garment changeover and missing documentation on aseptic connections between manufacturing systems as examples.
In total, the Medicines and Healthcare products Regulatory Agency (MHRA) visited 324 pharmaceutical manufacturing plants in 2016, 21 more than were visited last year. The organisation inspected 82 sites outside the UK, three more than were audited in 2015.
For the second year running problems with quality systems were the most commonly observed deficiency according to the MHRA.
Many of the systems problems related to how senior management implemented plans designed to ensure the quality of drug products made at their sites.
For example, the MHRA said at one site “senior management had failed to ensure an effective Quality Management System was in place as evidenced by the fact that a number of the CAPA from the previous MHRA inspection had not been completed on time.”
At another the agency said: “The management team was not seen to be reacting effectively to poor key performance indicators.”
In contrast with the increase in sterility issues, the MHRA saw fewer instances of problems related to the investigation of customer complaints or drug recalls at plant it visited in 2016.
In prior years such problems – previously categorized as investigation of anomalies – were the most common deficiency reported by inspectors.