LOGFILE Feature 21/2020 – Purpose and content of a management review

 26.05.2020

Purpose and content of a management review

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

5 minutes 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)

 

Author:

Stephanie Blum
Consultant, CEO
cirQum, Frankfurt/Main
Mail: stephanie.blum@cirQum.de

 


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?

>>> Order now your copy of The Road to a Phamaceutical Quality System!