ILC Tag

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 purpose and scope of the document is defined 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.”

The new document replaces the previous version I-SMI.RL.01_03 dated 26.05.2020, the changes concern the following chapters:

• Chapter 5.6: Handling of urgent follow up actions during the closing meeting including submission of information prior to completing the inspection report and its description in the inspection report
• Chapter 5.9: Clarification on expectations regarding critical and major deficiencies

SOURCES:

https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/bewilligungen_zertifikate/authorisations/inspectorates.html