Product Quality Reviews in the EU and US

Somerset House Consultants

Pharmaceutical companies in both US and EU must carry out annual quality reviews on each of their products.  Failure to provide these reviews is regarded as a GMP deficiency during regulatory authority inspections and can lead to action against the company and their Qualified Persons.

Why have a Product Quality Review?

The Product Quality Review is part of a continuous improvement quality system (as described in ICH Q10) and highlights where development resource can most effectively be targeted.  The data from these reviews can also assist with Risk Assessments described in ICH Q9 and contribute to ‘Quality by Design’ (QbD).

Who should prepare the Product Quality Review?

The Marketing Authorisation or NDA holder is responsible for the Product Quality Review.  This can be a problem for emerging or virtual companies that outsource production, distribution, stability testing or regulatory affairs to other companies.  They have to co-ordinate and review the information supplied from many sources.  In the EU, the Qualified Person should also review the final report.

Many companies are outsourcing the preparation of Product Quality Reviews to external specialists.  They liaise between the various contractors involved, ensure that all data is to the appropriate standard, and propose areas of improvement.

What does a Product Quality Review contain?

There are slight differences in emphasis and format between the FDA Annual Product Review and the EMA Product Quality Review, but the basic data requirements are similar.  

These include:

  • Quality of starting and packaging materials
  • In-process controls and finished product test results
  • Deviations, non-conformances, out-of spec (OOS) results and batch rejections
  • Changes to processes or analytical methods
  • Changes to Marketing Authorisations
  • Stability testing and review of retention samples
  • Returns, complaints and recalls
  • Adverse events
  • Process and equipment validation results
  • Supplier and contractor audits
  • Technical/Quality Agreements with suppliers and contractors

Somerset House Consultants has considerable experience with preparing Product Quality Reviews for companies worldwide.  Our experienced consultants and Qualified Persons can free up the internal resource needed to acquire and review the data, and can ensure that the final reports meet all regulatory authority expectations.

Product Quality Reviews

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