In a new Recommendation for Risk-Based Inspection Planning in the GMP Environment, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) asks Inspectors to have a look at job cuts.
The PIC/S Expert Circle on Quality Risk Management has developed a 'Recommended Model for Risk-Based Planning in the GMP Environment' (PI 037-1). This Recommendation contains Quality Risk Management tools that may be used by inspectorates when planning frequency and scope of GMP-inspections.
A two-page quality risk management worksheet is introduced, which should be filled out by the inspector right after the inspection, rating the manufacturing site inspected. This should be done on the basis of an estimated risk with respect to patients, consumers, animals and product quality. Because the methodology requires knowledge of the GMP-compliance status of the site, the planning of inspections at new manufacturers is not covered by this Recommendation.
What is interesting in this document is the fact that inspectors should also consider the impact of job cuts at the manufacturing site: "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" and because job cuts can "lead to compliance problems later on".
This document was adopted by the PIC/S Committe Meeting on 19 December 2011 and entered into force on 1 January 2012.
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