An excerpt from the GMP Series e-book The Road to a Pharmaceutical Quality System
Purpose and content of a management review
Nevertheless, many pharmaceutical companies do not place enough emphasis on management reviews. Like the quality policy, the management review is based on ISO guidelines [1]. Although ICH Q10 adapted this tool for the pharmaceutical industry in 2008, it only became mandatory for European pharmaceutical companies when the revised version of Chapter 1 of the EU GMP Guidelines came into effect on 31 January 2013.
The management review examines the effectiveness of the PQS using defined key performance indicators. It checks, in particular, whether the quality objectives defined during quality planning have been achieved. This annual review is carried out once or several times based on the data that has already been continuously collected using existing PQS tools. It includes, above all, the overviews (or data bases) on CAPA, deviations, changes, complaints, etc. as well as the results of internal or external audits.
Figure 1.M-1 and Figure 1.M-2 contain an overview of the contents of the management review in accordance with ISO 9001 and ICH Q10. ICH Q10 divides a management review into two parts: a review of the process performance and a review of the PQS. However, this division leads to overlapping and redundancy and increases the likelihood of the collected data being incorrectly interpreted. For example, inspection results and elements such as CAPA, changes and complaints are considered twice during the evaluation.
Figure 1.M-1 Management review in accordance with ISO 9001
Input for a management review in accordance with ISO 9001:2008 |
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| Output for a management review in accordance with ISO 9001:2008 |
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Figure 1.M-2 Management review in accordance with ICH Q10
Input for a management review in accordance with ICH Q10 |
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| Potential management monitoring tools in accordance with ICH Q10 |
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| Output of the management review and monitoring in accordance with ICH Q10 |
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The implementation of these requirements in practice is explained in the section below that focuses on the following aspects:
- Contents of management reviews
A management review consists of two parts: the management review input and the management review output (result) - Implementation of management reviews (process frequency and responsibilities)
[1] DIN EN ISO 9001:2008, version DIN EN ISO 9001:2008-12, including DIN EN ISO 9001 Amendment 1:2009-12, Quality management system – Requirements (DIN EN ISO 9001:2008-12)
The Road to a Pharmaceutical Quality System
You’ll discover how to look beyond the multiple silos that so easily develop around individual drugmaking activities. You’ll be ready to implement new problem-solving approaches at every level of your manufacturing operations.
The Road to a Phamaceutical Quality System walks you step by step through the processes and procedures you’ll need to put in place.
Here’s what you’ll learn:
- What are the key elements of the PQS?
- What roles do quality policy and quality planning play?
- What are the responsibilities of management?
- How are the regulatory requirements implemented in practice?
- What is the significance of documentation for the PQS?
- Is a PQS documentation hierarchy necessary (documentation pyramid)?
- What GMP documentation does a pharmaceutical company need?
- What is a quality manual and how is it created?
- Why is a management review carried out and what does it involve?
- How are suitable key performance indicators defined?
- What results does a management review deliver and how are they evaluated?
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