Update of the PIC/S Recommendation on the Validation of Aseptic Processes

On 7 February 2009, the PIC/S Document 007-4 "Recommendation on the Validation of aseptic processes" was updated. The PIC/S recommendations serve as guidelines to inspectors of the PIC/S countries during inspections of pharmaceutical companies.

The changes to PI 007-4 are of minor importance and mainly concern the requirements on the incubation conditions during media fills. Formerly, 2 alternative schemes existed:

1: 20-25oC for a minimum of 14 days

2. 20-25oC for a minimum of 7 days followed immediately by incubation at a higher temperature range not to exceed 35oC for a total minimum incubation time of 14 days

Other incubation conditions were possible provided that their necessity could be proved.

The updated version lays down the following incubation conditions:

20-25oC for a minimum of 7 days, followed immediately, or after a first reading, by incubation at 30-35oC for a total minimum incubation time of 14 days. Other incubation conditions are allowed if validated beforehand.

However, the document has not been fully updated and partly contradicts the requirements of the new Annex 1 to the EC GMP Guide, which comes into force on 1 March 2009. Especially in the interpretation of media fill data, a contamination rate of less than 0.1% with a 95% confidence level is still accepted. There is an urgent need to adapt the specifications to those of Annex 1 and the FDA Guidance for Industry "Sterile Drug Products produced by aseptic processing".

The PI 007-4 can be found here.

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

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