|
Both parts of the EU GMP Guideline introduced a powerful quality
management tool: the Product Quality Review (PQR). After a transitional
period, the PQR is getting more and more important in recent inspections.
In a GMP-Symposium held by the Inspectorate Darmstadt, Germany, it was
emphasised that the Product Quality Review "is a must" (Rudolf Völler,
16.11.2006).
In another example, the Irish Medicines Board said at their 2005
Pharmaceutical Manufacturing Workshop that actual reviews will be looked
after 1st January 2007.
But also members of the Pharmaceutical Inspection Convention and
Pharmaceutical Inspection Co-operation Scheme (jointly referred to as
PIC/S), like the Health Science Authority of Singapore have adapted the PQR.
In their
Guidance Notes on Product Quality Review, the authority states that
the "Product Quality Review is an important aspect of Good Manufacturing
Practice" and that it is important for manufacturers and marketing
authorization holders to conduct this review.
In their revised GMP Guideline 2007 Edition (GUIDE-0001), which has been
published for comments, Health Canada has added a whole new chapter dealing
with an Annual Product Quality Review.
By the way: the FDA issued two Warning Letters in the fiscal year 2006
for failure to establish the Annual Product Review.
|
