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Gmpjbk1 scribd uploaded j bk 002 abstract only


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Gmpjbk1 scribd uploaded j bk 002 abstract only

  1. 1. GOOD MANUFACTURING PRACTICE (GMP) IN THE PHARMACEUTICAL INDUSTRY: A COMPARATIVE STUDY OF COMPANIES IN NEPAL AND THAILAND by Jaya Bir Karmacharya ABSTRACTQuality, efficacy and safety of drugs have always been a matter of concern for the public. Inthe manufacture of drugs, overall control is essential to ensure that the customer receivesdrugs of high quality. Haphazard operation cannot be permitted in the manufacture of drugs.World Health Organization (WHO) has developed guidelines called Good ManufacturingPractice (GMP) to outline steps that should be taken by manufacturers of drugs with theobjective of ensuring that their products are of the nature and quality intended.In Nepal, pharmaceutical companies have been developed since 1971. The companies werebuild and operated without having specific guidelines and regulations. The regulatory act, theDrugs Act 1978, was passed and promulgated only in 1978. As the industrial and regulatorydevelopments have not occurred simultaneously, there exists a wide gap in GMP concepts andits implementation in different companies. To ensure production of quality, safe andefficacious drugs at competitive prices, a detailed understanding of the implementation ofGMP norms in the pharmaceutical industry would be essential.As a result this study was done to investigate and evaluated the practical implementation ofGMP norms in the pharmaceutical companies in Nepal in comparison with that of Thailand. Aconceptual framework was developed based on WHO guidelines on GMP to conduct thestudy. This study was conducted with six companies in Nepal and five companies in Thailandto evaluate in detail ten components of GMP.This study provides an overview on the situation in practical implementation of GMP in thepharmaceutical companies in Nepal and Thailand. The results of this study have indicated theweakness in practical implementation of GMP in the Nepalese companies as compared tothose of Thailand. This study concludes with the recommendations to formulate a nationalGMP team for developing national GMP guidelines and to enforce the guidelines for effectiveimplementation of GMP for the production of quality, safe and efficacious drugs. The scopefor further research is also suggested. i