Switzerland: Update of the Technical Interpretation on the PQR

Swissmedic's Technical Interpretation I-SMI.TI.14e describes the minimum expectations for the preparation and assessment of a Product Quality Review (PQR) that inspectors may have during an inspection of a manufacturer of medicinal products, a manufacturer of active pharmaceutical ingredients (APIs) for medicinal products or a marketing authorisation holder.

The importance and requirements for conducting annual Product Quality Reviews are described and defined in the Guide to Good Manufacturing Practice for Medicinal Products, Part I and Part II (Eudralex Vol. 4), and the PIC/S document PE 009. The PQR is a key document for checking the consistency of a manufacturing process.

The changes are described in chapter 5 of the current version 7.0. Among other things, responsibilities for the preparation and evaluation of the PQR between the manufacturer and the marketing authorisation holder are clarified.

The interval for preparing a PQR if only a few batches have been produced (or no production has taken place) has been reduced from 5 years to 3 years.

Chapter 4.6 (Parallel imported products) is completely new: Even though the marketing authorisation holder of a parallel imported product usually does not have access to the PQR of the manufacturer of the product, he should however verify that the product consistently complies with the requirements laid down in the marketing authorisation and he should have a procedure described in a standard operating procedure to conduct a quality review of specific aspects for parallel imported products (i.e. complaints, recalls, quality deficiencies).