Purpose and content of a management review

18.05.2020

LOGFILE Feature

An excerpt from the GMP Series e-book The Road to a Pharmaceutical Quality System

0 min. reading time | by
Published in LOGFILE 21/2020

5 min. reading time | by Stephanie Blum

A management review is carried out on a regular basis to check the suitability and effectiveness of the pharmaceutical quality system (PQS). It is one of the most effective PQS tools available.

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

Audit results

Customer feedback

Process performance and product compliance

Status of preventive and corrective actions

Follow-up measures from previous management reviews

Changes that may affect the quality management system

Recommendations for improvement

Output for a management review in accordance with ISO 9001:2008

Improved effectiveness of the quality management system and its processes

Improved product with regard to customer requirements

Resource requirements

Figure 1.M-2 Management review in accordance with ICH Q10

Input for a management review in accordance with ICH Q10

Inspection and audit results

Periodical quality reviews that may contain the following:
- Measurement of customer satisfaction (complaints, recalls)
- Conclusions from process performance monitoring and product quality monitoring
- The effectiveness of changes affecting the process or product including changes that result from CAPA measures

Follow-up measures from previous management reviews

Measurement results with regard to the realisation of defined quality targets

Measurement results of key performance indicators which are used to monitor the effectiveness of the PQS processes, e.g.:
- Complaints, deviations, CAPA, change management
- Feedback on outsourced processes
- Self-evaluation processes including risk evaluations, trending and audits
- External evaluations (results of inspections and audits)

Potential management monitoring tools in accordance with ICH Q10

Developing regulations that have an impact on the existing quality management syst

Innovations that may improve the existing PQS

Changes in the business environment and business objectives

Changes in product ownership rights

Output of the management review and monitoring in accordance with ICH Q10

Improved manufacturing processes and products

Improved PQS and related processes

Revision of the quality policy or quality objectives

Provision and (re)organisation of resources, training

Gaining and sharing knowledge

Documentation and immediate and effective communication of the management review results including escalation to senior management

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)

Do you have any questions or suggestions? Please contact us at: redaktion@gmp-verlag.de

Dr. Stephanie Blum Written on 18 May 2020

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