Stretched regulatory resources are driving a shift towards risk-based inspections. To help regulators the Pharmaceutical Inspection Co-operation Scheme (PIC/S) has drafted a document, in which it warns inspectors to be wary of the GMP (good manufacturing practice) implications of job cuts.
“Significant changes in the number of personnel at a site are also useful to consider from a risk perspective during the review phases, because…they may mean that there are fewer quality assurance resources available at the site”, PIC/S wrote in its recommendation.
PIC/S said such job cuts can “lead to compliance problems later on”. Last year Johnson & Johnson (J&J) cited job cuts as a factor in its quality woes. J&J cut its global quality and compliance (Q&C) headcount by 35 per cent cut and said it “should have paid more attention to Q&C”.
Increases to headcount may also be significant as the shift could “indicate a change in the complexity of the site”. PIC/S wants regulators to be aware of such cuts or expansions and factor them into risk-based inspection plans.
Regulators could respond to a significant shift in headcount by raising the risk level of a production site. This would result in the manufacturing facility being inspected more often or change the scope of the next regulatory visit.
Information about headcount changes is one of four factors that can prompt a review of a plant’s compliance risk. The other factors are: information about quality defects; changes to manufacturing authorisations; and a company’s report in response to its most recent inspection.
Calculating risk
These factors can prompt a reassessment of compliance risk but other information is used in the first calculation. Initial considerations recommended by PIC/S can be separated into two groups: intrinsic risks and compliance risks.
Intrinsic risk is calculated by assessing the complexity of a manufacturing facility and its processes, as well as the criticality of its products. For both these factors a score of one to three is given to show the risk.
To calculate risk these factors are considered alongside compliance issues. Compliance risk is based on deficiencies found during the last inspection. If inspectors found five or more major deficiencies, or at least one critical failing, PIC/S would consider the plant to have a high compliance risk.
Ratings for compliance and intrinsic risk are combined in a matrix table to calculate how often a site needs inspecting. Suggested inspection frequencies range from less than one year to up to three years.
The PIC/S recommendation came into force this year.