The World Health Organization (WHO) has organized a training on Current Good Manufacturing Practice (cGMP) which started on 8 September 2020. So far, five sessions have been conducted and seven remain. The objectives of the training are (1) local manufacturers to increase their technical knowledge on cGMP to enable them produce quality assured medical products by improving cGMP compliance in their respective facilities and (2) the National Medicine Regulatory Authority staff to increase their technical knowledge on cGMP so that they can apply it during regulatory inspection of local medical products manufacturer and reduce the risk of producing poor quality medical products.

The sessions are conducted once a week and the topics covered are: Pharmaceutical Quality Systems; Quality Risk Analysis and Management; Premises and Plant Design Layout Principles; and Contract Production and Analysis.

This training is being attended by National Medicine and Food Administration staff. The training link has also been shared with Azel pharmaceutical company, for interested staff to take part in the training.

Session 1 focused on Pharmaceutical Quality Systems (PQS) and its main elements, as part of quality management system. The importance of defining and documenting PQS, periodic management review and continual improvement of PQS were highlighted.

It covered activities incorporated within the PQS including Good Manufacturing Practices (GMP) and others such as product design and development.

In session 2, a brief introduction to quality risk analysis and quality risk management, with respect to ICH and PIC/S GMP guidelines, was provided. An overview of a typical risk management process including cycles of risk assessment, risk control, risk review and risk communication was given.

The objective of session 3 was to identify general requirements for premises in pharmaceutical manufacturing and the specific requirements for the various areas used for different activities. This covered planning methods, the need for focusing and rationalization, optimization and innovation. The aim of layout and design, which involved minimizing errors, cross contamination, effective cleaning and others, were also discussed.