Update of the PIC/S Recommendation PI 007-4 Validation of Aseptic Processes

On 1 July 2009 the PIC/S Document 007-5 "Recommendation on the Validation of Aseptic Processes" was updated again. The recommendations by PIC/S give guidance to inspectors of PIC/S countries within the framework of the inspection of pharmaceutical enterprises.

This time, the changes to PI 007-5 regard the acceptance criteria for media fills (Chapter 6: Interpretation of  Data). While in the past, the interpretation had referred to the old Annex 1 to the EC GMP Guide, with the update of the document the requirements were now taken over from the new Annex 1, which came into force on 1 March 2009.

A summary of the updated requirements:

6.1 Contaminated containers should be checked for evidence of deficient container or closure and for an influence of the deficiency on the integrity of the packaging system. Damaged contaminated containers should not be rated as "positive".

6.2 Acceptance limits: Corresponding to the media fill scope, divided into up to 5,000 units, between 5,000 and 10,000 units and more than 10,000 units. These were taken over unchanged from Annex 1 to the EC GMP Guide. A zero growth is expected!

6.3 Investigation of contaminated units: This, too, was taken over identical from Annex 1 to the EC GMP Guide.

6.4 In order to determine the source of contamination, the microorganisms of all "positive" units shall, where practicable, be identified at least to genus, preferably to species.

6.5 In case of a failed media fill, special attention should be paid to the products produced since the last successful media fill. For this reason, records of any deviation in simulation are important for an investigation of the cause and an evaluation of the consequences. The investigations are meant to identify batches that could be affected. A re-assessment should be carried out for possibly affected batches.

Conclusion: The document was updated to the current state of Annex 1 to the EC GMP Guide.

PI 007-5 can be found here.
Annex 1 to the EC GMP Guide can be found here.

Dr Andreas Mangel
On behalf of the European Compliance Academy (ECA)

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