GOOD MANUFACTURING PRACTICE (GMP) IN THE PHARMACEUTICAL INDUSTRY: A COMPARATIVE STUDY OF COMPANIES IN NEPAL AND THAILAND by Jaya Bir

Karmacharya

ABSTRACT Quality, efficacy and safety of drugs have always been a matter of concern for the public. In the manufacture of drugs, overall control is essential to ensure that the customer receives drugs of high quality. Haphazard operation cannot be permitted in the manufacture of drugs. World Health Organization (WHO) has developed guidelines called Good Manufacturing Practice (GMP) to outline steps that should be taken by manufacturers of drugs with the objective of ensuring that their products are of the nature and quality intended. In Nepal, pharmaceutical companies have been developed since 1971. The companies were build and operated without having specific guidelines and regulations. The regulatory act, the Drugs Act 1978, was passed and promulgated only in 1978. As the industrial and regulatory developments have not occurred simultaneously, there exists a wide gap in GMP concepts and its implementation in different companies. To ensure production of quality, safe and efficacious drugs at competitive prices, a detailed understanding of the implementation of GMP norms in the pharmaceutical industry would be essential. As a result this study was done to investigate and evaluated the practical implementation of GMP norms in the pharmaceutical companies in Nepal in comparison with that of Thailand. A conceptual framework was developed based on WHO guidelines on GMP to conduct the study. This study was conducted with six companies in Nepal and five companies in Thailand to evaluate in detail ten components of GMP. This study provides an overview on the situation in practical implementation of GMP in the pharmaceutical companies in Nepal and Thailand. The results of this study have indicated the weakness in practical implementation of GMP in the Nepalese companies as compared to those of Thailand. This study concludes with the recommendations to formulate a national GMP team for developing national GMP guidelines and to enforce the guidelines for effective implementation of GMP for the production of quality, safe and efficacious drugs. The scope for further research is also suggested.