Improve your Quality Reviews - PQR, APR, Management Review

Improve your Quality Reviews  - PQR, APR, Management Review

Copenhagen, Denmark

Course No 15156


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Dr Rainer Gnibl, GMP Inspector for EMA
Prof Edwin van den Heuvel, University of Technology Eindhoven
Dr Andreas König, Aenova Holding
Katja Kotter, Vetter Pharma-Fertigung


This course examines regulatory requirements, provides insight into inspectors’ expectations and provides tools for improving your documented review processes.

Based on real examples you will learn how you can implement and improve your Quality Reviews and use them more efficiently.


Quality Reviews are critical GMP elements. They are an integral part of a pharmaceutical quality system and provide an opportunity to assess and control relevant processes.

Both parts of the EU-GMP Guideline require the Product Quality Review (PQR). The aim of this requirement is to verify
the consistency and appropriateness of existing processes,
the adequacy of current specifications for starting material and finished product
and to identify product and process improvements.

The FDA 21CFR 211 requires an Annual Product Review (APR) to evaluate annually the quality standards of each drug product.

All relevant guidance do also consider a Management Review to be an appropriate instrument to assess adequacy and effectiveness of quality systems.

All these different reviews could result in a tremendous work load or they can be performed in an efficient way with useful results – depending on how they are organised. Therefore it is very important to understand the
requirements and the idea behind it and to see how these tools can be used more efficiently.

Target Group

This Education Course is designed for managers, supervisors and all other staff members in the pharmaceutical and API industry who are involved in preparing and compiling Quality Reviews.

Every participant will get:

  • an example for a PQR SOP with Annexes
  • an example for a Management Review SOP
  • real PQR examples
  • extracts from real Management Reviews


Quality Reviews in the Context of FDA, EU and ICH

  • Requirements and Expectations
  • EU-GMP: which types of Quality Reviews are required?
  • EU Quality System Review (overview)
  • How to achieve EU-GMP compliance
  • ICH/US-FDA view on the situation (overview)
  • EU Product Quality Review (PQR)
  • Technical terms and aims of PQR
  • What documents and data should be reviewed?
  • Are EU-requirements the same for APIs & medicinal products?
  • What about US-FDA and ICH?
  • Product reviews in other countries (overview)
  • How to combine PQR and APR in an efficient way
  • Well-proven PQR/APR designs
  • Interface to Regulatory Affairs
  • Certainties (PQR/APR in Custom Manufacturing, how to deal with limited numbers of batches …)
Set up of efficient PQRs and APRs
  • How to profit from existing QA Systems in PQR/APR and vice versa
  • Best practices
  • Time/efforts needed
  • Ongoing data collection
  • Foreseeable complications/advantages
  • Well-proven examples
Workshop: Evaluation of given PQR-Examples
  • Evaluate with other Delegates the content and lay-out of given PQR-examples and discuss it with the Speakers
  • What is useful?
  • What is ambiguous?
  • What could be improved?
The Application of statistical Tools in Data Review
  • Ongoing/data collection and management
  • Interpretation, comparison and presentation of data
  • Describing process capability and performance
  • Control Charts; what is a trend and how to deal with it?
  • Quality Metrics
  • Documenting the outcomes; are we in control?
Workshop: What are the data telling us?
A case study on analysing and interpreting process performance data.

EU Product Quality Reviews in the Light of Inspections - Expectations of the Agencies
  • Inspectors view on critical parts of EU-PQR
  • Practical implementation and inspection
  • PQR and contract manufacturing
  • Comparison EU-PQR and US-APQR (inspectors point of view)
Management Review
  • Definition, scope, objectives
  • Organisation
  • Participants, responsibilities
  • Topics to be presented: input and output
  • KPIs per system
  • Examples and experience
Quality Reviews in Contract Manufacturing
  • Customer QMRs - content, scope, frequency, organisation
  • Interface with Business Management Reviews
  • Assessment of data, trending and decision making
  • Actions, follow-up
  • "Face to Face" or telecon?

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