Yesterday (20 July 2023) Switzerland's Swissmedic released an updated guidance on "Harmonisation of the SwissGMP/GDP Inspection System" that set a frame for the harmonization and steering of the Swiss GMP/GDP inspection system.
The guidance describes the Swiss GMP/GDP inspection system for medicinal products as defined by the TPA; and also defines and regulates the relevant interfaces between the Swissmedic sector Licensing, the Inspectorates of Cantons (IoC) and the Swissmedic Inspectorate (IoS).
The Swiss GMP/GDP inspection system is a system that consists of the Inspectorate of Swissmedic (IoS) and the Inspectorates of Cantons (IoC) and these are accredited regional inspectorates that perform GMP/GDP inspections for one or more cantons according to article 60 TPA.
The purpose of the inspections is to verify the compliance of manufacturers and distributors of medicinal products with the GMP/GDP standards. These are standards that ensure the quality, safety and efficacy of medicinal products by covering aspects such as premises, equipment, personnel, documentation, production, quality control, storage, distribution, recall and complaints.
The inspections are carried out according to a risk-based approach and follow the PIC/S (Pharmaceutical Inspection Cooperation Scheme) document PI 002 (Recommendation on Quality System Requirements for Pharmaceutical Inspectorates).
Based on the inspection results and the corrective and preventive actions plan (CAPA plan) submitted by the inspected company, the inspectorate issues a proposal to Swissmedic on whether the establishment licence should be issued, renewed, changed, suspended or withdrawn. Swissmedic then makes the final decision and informs the company accordingly.
The guidance sets a frame for the harmonization and steering of the Swiss GMP/GDP inspection system by:
Establishing a common understanding of roles and responsibilities among all parties involved
Defining uniform criteria for planning, conducting and reporting inspections
Ensuring consistent interpretation and application of legal requirements and standards
Providing mechanisms for information exchange, coordination and cooperation
Implementing measures for quality assurance and improvement.
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