Session Speaker

Evaluation of Pharmaceutical Inspection Practices
Ranya Hassan, Raida Al-Kassas, Zaheer-Ud-Din Babar, Sanjay Garg
New Zealand

Aims: The process of inspection of pharmaceutical facilities is to ensure that they comply with the requirements and international guidelines of Good Manufacturing Practices (GMP). In the developed world, compliance with the GMP is well established, however, in many developing countries, pharmaceutical companies are in the process of obtaining GMP in order to meet the inspection requirements of their export markets. The objective of this research was to evaluate the best practices and models for inspection and auditing of pharmaceutical manufacturing facilities for GMP compliance. Another objective was to compare the inspection practices of selected developing and developed countries. The developing countries were United Arab Emirates, the Kingdom of Saudi Arabia, Egypt and Jordan while New Zealand was used as an example of a developed country.

Methods: A cross-sectional study was conducted to collect quantitative and qualitative data from participants from different countries. Two different targeted participants were involved - inspectors from health regulatory authorities and the quality assurance staff working in pharmaceutical companies.

Results: In many ways the regulatory inspections in the developing Arab countries meet similar standards to those of New Zealand and of the world’s strictest regulatory agencies such as the United States Food and Drug Administration (USFDA) and European Medicines Evaluation Agency (EMEA). However in some of the areas where inspections processes in developing countries could be improved are advance warning of a regulatory inspection; more aggressive requirements for implementing corrective actions and advising the regulatory inspector that the actions have occurred. Some of the other suggestions are mandatory appropriate qualification and relevant experience for inspectors, ensuring that the training of inspectors meets international standards, regular updates and improved contact with other health regulatory bodies.

Conclusions: It is important for the credibility of the health authorities in the developing countries that their GMP inspection practices meet international standards and that the certification that they issue will withstand scrutiny by overseas regulatory authorities. A set of recommendations to improve the inspection efficiency has been developed and will be presented.