Pharmaceutical Inspection Co-operation scheme adopts new guidance on GMP inspections

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has adopted new guidance on good manufacturing practice (GMP) inspections. The guidance outlines the process for “desk-top assessment” of overseas facilities to identify cases when an acceptable level of GMP compliance can be confirmed and assured without on-site inspections.

The guidance is based on a draft from the International Coalition of Medicines Regulatory Authorities (ICMRA), and provides a tool and framework that aims to help competent authorities (CAs) prioritise resources for GMP inspections for human and veterinary medicines. The guidance also aims to improve sharing of inspection information between authorities.

The new guidance is applicable on a voluntary basis for ICMRA and PIC/S participating authorities and thus, does not supersede country/regional guidance, procedures or legislation where they exist.

PIC/S states that “the procedure should include the information that is needed to make an informed regulatory decision about site compliance, triggers and risk factors that would result in an inspection being required, and how the assessment and outcome should be recorded”. Assessing the gathered information aims to gain assurance that GMP compliance has been established by the hosting CA and that there is no new evidence that would warrant an on-site inspection by the requesting CA.

Two chapters in the guide have been revised to include requirements to prevent cross-contamination. Another revised chapter also introduces a change in the qualification of suppliers. PIC/S states that the revised GMP guide will enter into force on 1st July 2018.

PIC/S has invited all non-European Union/European Economic Area participating authorities (and applicants) to transpose the revised chapters of the PIC/S GMP guide into their own GMP guides.

To view the press release from the PIC/S meetings in Geneva, from 16th to 18th April 2018, please click here.