Swissmedic resumes Inspections
Recommendation

27/28 May 2026
Batch Manufacturing Documents: from Preparation to Operational Excellence
Swissmedic, the Swiss Agency for Therapeutic Products, has announced "to resume regular on-site inspections", provided that the "necessary protective measures can be complied with". A safe inspection procedure must be guaranteed for all those involved.
Before the GMP/GDP inspection, the company to be inspected must fill out a questionnaire. This questionnaire contains instructions and measures which should be observed during the inspection. The companies are asked to complete the questionnaire and to confirm the measures accordingly.
On site, the inspected company must then make appropriate arrangements, such as "meeting rooms with sufficient space, restricted number of participants, electronic resources" and wearing face masks if necessary.
Related GMP News
22.04.2026No Validation, No Controls, and No Suitable Rooms and Equipment - Extensive Warning Letter
25.03.2026FDA Warning Letter highlights once again: Weaknesses in the CAPA Process remain a key GMP Issue
18.03.2026FDA Issues Draft Guidance on Responding to Form 483 Observations
28.01.2026What is the Procedure for GMP Inspections (EU GMP inspections and FDA Inspections)?
21.01.2026FDA Warning Letter highlights critical Failures in Supplier and Quality Oversight
19.01.2026GMP Auditor Association Developments September through December 2025


