Workshop on good manufacturing practices regulatory inspection using the risk-based approach

GMPThe WHO country office in Egypt, in collaboration with the Egyptian National Regulatory Authority, organized a week-long workshop on good manufacturing practices regulatory inspection using a risk-based approach” in Cairo from 9 to 13 July 2017. 

It addressed around 26 participants from the Egyptian National Regulatory Authority, as well as some Egyptian manufacturers, to achieve the main objectives of ensuring that the regulatory inspection function of the Authority in Egypt will be performed against the WHO recommended standards and also to improve the knowledge, skills and experience of Egyptian inspectors in conducting GMP inspections. 

This workshop covered several modules such as basic principles of GMP, quality risk management, etc. In addition, a mock inspection took place in 4 different pharmaceutical manufacturers so that participants would practise what they had learnt and effective decision-making enabled based on newly-acquired knowledge and experience. 

The workshop is one of the activities which were included on an agreement between the Egyptian National Regulatory Authority and WHO during the self-benchmarking workshop in September 2016.