Conclusion and recommendations
The EU product quality review (PQR) requires a greater number of items and areas for review compared with either the US product
annual review (PAR) or Q7A PQR, and expands the review to include quality systems and registration commitments. Despite this
expanded review, it does not incorporate two of the three major FDA objectives for the review. The Q7A PQR is very similar
to the EU PQR, although it does not include nearly as many areas and items for review as the EU PQR. The Q7A also does not
include any of the three objectives of the FDA PAR.
The expanded review required by the EU PQR may not necessarily require additional time and resources, compared with the FDA
PAR review, because the EU PQR allows for the grouping of products together in one review whereas the FDA does not. If a company
decides to perform one PAR/PQR to satisfy both FDA and the EU, then, they would need additional resources to perform an expanded
review, for each product. Companies that supply the US and EU markets should, therefore, decide on the approach that is the
most effective, efficient, and economical before rushing to develop or redevelop their PAR/PQR program.
As with all GMP guidance information, it is always valuable to try to understand the underlying principles to respond in a
way that both meets the GMP requirement or expectation and strengthens the quality system with ultimate benefit to the patient.
This is a shared goal of both regulators and industry. By presenting some of the background information relevant to the PAR/PQR,
comparing it with other well-established reviews and outlining one possible approach (i.e., a modular approach) to meeting
the EU PQR requirements, compliance can be achieved from a stronger foundation.
John G. Grazal is senior director of the Global Compliance Management Group at AstraZeneca (Wilmington, DE). John Y. Lee* is executive director at Pharmaceutical Compliance Associates, and a former FDA investigator at New Jersey District, 523
No. Bay Avenue, No. Massapequa, NY 11758, tel: 516.752.0998, fax: 516.752.8931, e-mail: email@example.com
*To whom all correspondence should be addressed.
Submitted: May 10, 2007. Accepted:Aug. 23, 2007
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