PIC/S publishes new Aide-Memoire on the Inspection of Manufacturers of Active Pharmaceutical Ingredients

In January 2009, the PIC/S (Pharmaceutical Inspection Convention Co-Operation Scheme) published a new Aide-Memoire to provide guidance for inspectors inspecting API facilities.

PIC/S believes that the majority of inspectors are more familiar with the inspection of finished products than with the inspection of active pharmaceutical ingredients (API) manufacturing sites. The purpose of this document, which is based on the ICH Q7 Guide and on the adapted Guide of the PIC/S PE 009-8 Part II, is to provide guidance for inspectors preparing and performing inspections in API manufacturing sites. At the same time, it provides valuable information for the API manufacturer to prepare for inspectors' questions.

Like other PIC/S Aide-Memoires, the document is written in tabular form. It lists possible inspection -questions sorted according to different topics. At the same time, it refers to relevant basic documents such as other PIC/S Guides, pharmacopoeia or documents written by the manufacturer such as the Site Master File or the Validation Master Plan.

Apart from more general items of quality assurance such as change control, product quality review, complaints and recalls, the document also lists more API -specific inspection subjects such as:

  • Containment
  • Reprocessing/Rework
  • Mixing of batches
  • Tank farms
  • Solvent recovery

But the document also lists inspection -questions concerning packaging/labelling, suppliers' qualification, storage, water, qualification and validation (including cleaning validation and retrospective qualification).
With regard to the content, the document offers no big surprises, but it does provide valuable information for the API manufacturer to prepare for inspectors' questions.

You can find the new document here.

Dr Robert Eicher
On behalf of the European Compiance Academy (ECA)

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