PIC/S Site Master File Guide Updated on Quality Management System Expectations

The Pharmaceutical Inspection Cooperation Scheme (PIC/S) has adopted a rewrite of its site master file (SMF) guide for industry that upgrades the expectations on quality management systems (QMS) – and the quality risk management (QRM) and supply chain components in particular – to keep pace with ICH Q9 and Q10.

The revision of the “Explanatory Notes for Industry on the Preparation of a Site Master File” was approved at the PIC/S semiannual meeting held in November in Kuala Lumpur, Malaysia and released in late December with a January 1, 2011 official date.

The revised text reflects the simplified format and many of the changes proposed by EMA in its redraft of the guide released for comment last December.  Additional changes were made to reflect the comments that came in and to further simplify and clarify the expectations.

The focus within PIC/S on improving its directions on site master files reflects their growing importance as a facilitator of the GMP inspection process in Europe and globally, including in China (IPQ “In the News” November 29, 2010).

The US entry into PIC/S in 2011, which was also approved at the Kuala Lumpur meeting (see the companion December 29 “In the News” story), gives further weight to the significance of the organization’s dialogue around SMFs.

The revised site master file guide provides a more transparent template and roadmap for what regulatory agencies want to see as their inspection focus shifts onto assuring that pharmaceutical manufacturers have a quality system strong enough to manage the details of their GMP responsibilities at a particular facility, across sites and through the supply chain.

[Analysis of the revisions to the PIC/S site master file guide and their significance is provided for subscribers here. Non-subscribers can purchase the full story for $95 by contacting Karen Bertani (Jonathan@ipq.org). For subscription information click here.]