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GMP News

FDA Inspection as GMP Evidence? Swissmedic Opens Up a New Option

With Version 7.0, Swissmedic expands the options for demonstrating the GMP compliance of FDA-inspected active substance and medicinal product manufacturers.

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FDA Warning Letter: Deficiencies in Stability Testing, Supplier Qualification, Validation and CGMP Oversight

In a recently published Warning Letter, the FDA describes significant and repeated CGMP deficiencies at a U.S. manufacturer of over-the-counter (OTC) products. The observations concerned incoming material controls, stability testing, process and cleaning validation, quality unit oversight, and the implementation of previously committed corrective actions.

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New: Coordination of GMP Inspections for Centrally Authorised Products

In the 'Compilation of Union Procedures on Inspections and Exchange of Information', the document on the coordination of GMP inspections for centrally authorised medicinal products has been updated. However, the changes are only minor and mainly concern supporting authorities.

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