Specifications for the content of the GMP management review are contained in the ICH Q10 quality guideline, which was adopted in Part III of the EU GMP guideline.
The monitoring activities listed in Part III Section 3.2.4 describe the first of two main tasks of the management review and relate to the performance of the manufacturing processes and product quality.
Chapter 4 covers the second main task: continuous improvement of the pharmaceutical quality system. Section 4.1 requires management to have a formal process for periodic review of the pharmaceutical quality system. Performance indicators are to be established and applied to verify the effectiveness of the quality system. Section 4.2 proposes internal and external factors affecting the quality system for continuous monitoring. Above all, new upcoming regulations, guidelines and quality aspects are mentioned. Section 4.3 describes the potential results of the management review.
The suggestions for monitoring parameters or performance indicators described in ICH Q10 can be adopted as a basis in an in-house SOP for the GMP management review. Practice shows that often only a small part of these suggestions are included in the company’s own SOPs – probably also in order to keep the effort for the management review to a minimum. This is both a shame and risky, as early and regular involvement of top management in quality problems and their causes can reduce patient risk with regard to the manufactured medicinal products and should be used for this purpose.
In addition to defining the content and performance indicators, a practical version of a management review SOP must describe how escalations and decision-making processes take place and how the measures discussed in the management review meeting are determined and implemented. It must be ensured that the management review is given its function as an important control tool and does not merely become a “passive notification to top management” or an “ineffective written on sheet of paper”. Specifically, this means that if the suitability and/or effectiveness of the quality system is assessed as inadequate, appropriate corrective measures must be decided and implemented.
If, for example, the management review reveals that it is no longer possible to process deviations in a timely manner due to a lack of human resources, prompt provision of resources should take place by redistributing or providing additional human resources.
Another and current example is the Contamination Control Strategy (CCS) required in the new Annex 1. In the case of aseptic manufacturing, appropriate performance indicators of the CCS must be defined to ensure adequate control of the microbiological load on the products. In turn, the performance indicators must be included in the management review so that top management is regularly informed of the status of contamination control and any problems that may arise.
These examples show that for critical quality issues timely communication to top management and joint decisions by top management and senior management are necessary. Furthermore, the management review is suitable for adapting regulatory changes. This includes a review with regard to additionally required performance indicators, similar to those required to assess the efficiency of the contamination control strategy.
Many companies hold the management review meeting once a year. However, this is usually a much too long period of time to be able to continuously monitor and control any quality problems that arise. At least one event per quarter is recommended. The effort can be reduced by suitable preparation, structuring and thematic definition of the individual meetings.