Swissmedic updates Guideline for Conducting Inspections

Swissmedic has updated the Directive I-SMI.RL.01, "Conduct of inspections of establishments manufacturing or distributing medicinal products or collecting blood." Version 4.0 was approved on 21 October 2024 and has thus entered into force.

The new document replaces the previous version from 2020, with changes to the following chapters:

• Chapter 5.6: Handling of urgent actions during closing meeting and its description in the inspection report
• Chapter 5.9: Clarification on expectations regarding critical and major deviations

The purpose of the document is indicated as "to provide guidance on the conduct of inspection of an establishment collecting blood, manufacturing or distributing medicinal products and holding or seeking an establishment licence [...] The Directive shall harmonise inspection procedures, frequency of inspections and follow-up procedures thus ensuring a consistent approach to assessment and decision-making by the competent Swiss inspectorates and Swissmedic as the competent Establishment authority."

According to chapter 5.1 of the directive, a GDP inspection typically includes the inspection of the following elements:

• Quality management
• Personnel
• Documentation
• Premises and equipment used for storage and delivery
• Storage, transports
• Documentation of distribution for the purpose of traceability
• Definition of mutual responsibilities for distribution in the contractual relationship
• Only for marketing authorisation holders: Regulatory compliance and the role of the responsible person(s)
• Complaints and recall procedure, pharmacovigilance
• Returns
• Self-inspections

The PDF file is available for download on the Inspectorates website.