Swissmedic: Update of the Technical Interpretation for PQR

Swissmedic has published an updated version of its technical interpretation for a Product Quality Review (I-SMI.TI.14e).

This technical interpretation describes the minimal expectations as well as recommendations for establishing and evaluating a PQR, that inspectors of the competent regulatory authority can have when assessing compliance with the guidance during an inspection of a manufacturer of medicinal products, a manufacturer of Active Pharmaceutical Ingredients (APIs) for medicinal products or a marketing authorisation holder, in order to assure a harmonized conduct of inspections.

The changes to the previous version are:

• Added: finished product (FP), MAH, Responsible Person, and Therapeutic products act (TPA).
• Defined: "responsible person."
• Text refinements; data comparison with previous reviews required; CAPAs must be documented in the Pharmaceutical Quality System.
• Clarified responsibilities for PQR establishment; textual refinements; ensured partial PQRs are accessible to the manufacturer/MAH.
• Clarified PQR evaluation responsibilities; refined country-specific aspects, including batch rejection/release data, change controls, contract reviews, CAPA evaluations, and stability program checks. Included batches temporarily authorized by Swissmedic.
• Introduced a new chapter on PQR process review responsibilities.
• Created a separate chapter for Technical Agreements.
• Reduced PQR interval from 5 to 3 years for low or no production cases.
• Clarified PQR establishment timelines for manufacturers and MAHs.
• Introduced a new chapter on parallel imported products.

Source:

Swissmedic: Technical Interpretation I-SMI.TI.14e