PIC/S Relationship is Impacting Process Validation Expectations in Asia Pacific Region, Although They Vary in Practice, ISPE’s Asia Network is Reporting

The strong influence of PIC/S in the Asia Pacific region is impacting the expectations for process validation, although those expectations vary significantly in practice, the ISPE Asia network is reporting.  

Process validation has been an active area of both benchmarking and training in the ISPE Asia network, which includes 14 affiliates. Valuable insights have been gained on the progress to date in the PV arena and the gaps that would need to be filled to bring countries into full alignment with the revised PIC/S GMP Annex 15.

The PIC/S GMPs match those in Europe, and the Annex 15 revision was adopted by PIC/S in early October a few days after its effective date in the EU (IPQ October 31, 2015 and IPQ October 29, 2015).

An analysis of how process validation is being handled across the Asia Pacific region was provided by industry consultant Maurice Parlane at the ISPE/PQRI PV meeting held in Silver Spring, Maryland in early October. Parlane is an active member of ISPE’s Australasia Affiliate, Asia Pacific Regulatory and Compliance Committee (RCC) and PQLI Process Validation Committee, and his talk reflected the sharing and benchmarking that has been taking place across the ISPE network.

The presentation on Asia at the ISPE/PQRI conference followed a review of the revised Annex 15 and its relationship with FDA’s PV guidance by the rapporteur for the annex revision, MHRA Senior GMP Inspector Norman Gray (IPQ October 31, 2015).

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