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ISSN 2063-5346
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Pharmaceutical Industry Regulatory Audits in D-8 Countries: Retrospective Analysis.

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Y.Ratna Sindhu1*, Jaya Sharma2, Pankaj Sharma
» doi: 10.48047/ecb/2023.12.5.089

Abstract

The pharmaceutical industry is an important sector that contributes significantly to the healthcare system in D-8 countries. Regulatory agencies play a critical role in ensuring that pharmaceutical products are safe, effective, and of high quality. To achieve this, regulatory agencies conduct regular audits of pharmaceutical facilities to assess their compliance with Good Manufacturing Practices (GMP) and other relevant regulations and standards. This study aimed to analyze the regulatory audits encountered by pharmaceutical industries in D-8 countries between 2018 and 2022. The study also revealed that regulatory agencies in D-8 countries face various challenges that affect the effectiveness of regulatory audits. These challenges include inadequate resources, limited technical expertise, and regulatory barriers. For instance, regulatory agencies may have limited funding, staff, and equipment to conduct effective audits.

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