Pharmaceutical Regulatory Affairs: Open Access

ISSN: 2167-7689

Open Access

Regulatory Approach to Ensure Quality of Products - An Indian Perspective of Missing Linkage


Kumar N and Jha A

The objective of the study is to assess the Indian perspective of nourishment through regulatory guidelines for quality system prescribed during manufacturing operations managed at plant level and distribution managed by supply chain management beyond manufacturing premises. Good Manufacturing Practices (GMP) and Good distribution Practices (GDP) are two prominent regulatory guidelines available to manage them within plant and outside plant respectively.

Method: The method study shall be exploratory studies based on data and facts derived from government organizations, regulatory bodies and scholarly literatures available on the subject matter. Indian government has reinforced the sampling of market samples for analysis in order to assess their quality. The product sample analysis results by CDSCO of Government of India has been analyzed to estimate the types of quality defects, in addition to making use of information from relevant literatures.

Results: The review of existing legislations available to directly or indirectly manage quality of pharmaceutical products, it is found that regulations are more centered towards the manufacturing operation, if quality is taken into consideration. There is need to maintain the overall quality of products by taking care during manufacturing process as well as during distribution operations, hence the linkage between regulatory guidance for these two operations must be established effectively.

Conclusion: The existing design of system is discrete with respect to management of quality during manufacturing and distribution operations for pharmaceutical products. Regulatory bodies are recommended to reinforce the effective linkage in regulations for manufacturing and distribution system through working paper, technical report series and or regulatory guidance.


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