Regulations in the pharmaceutical sector are dynamic, evolving to keep pace with new products and technologies. The Central Drugs Standard Control Organization (CDSCO), Government of India, continually updates its rules to ensure drug quality, safety, and efficacy. A significant development…
Loan Licensing in Pharmaceutical Manufacturing: Key Principles, Guidelines, and Regulatory Framework
Loan licensing in pharmaceutical manufacturing plays a crucial role by allowing companies to outsource manufacturing or testing operations to third-party facilities. This setup, governed by the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, helps pharmaceutical…
A Validation Master Plan (VMP) is a vital document for pharmaceutical companies, providing a detailed strategy for validation activities to ensure the consistent production of high-quality pharmaceutical products. This article will discuss the requirements for a VMP according to regulatory…
The quality of medical product should be maintained throughout their shelf life and storage play a crucial role in this process. Storage of medicinal product is not only just providing the physical space for keeping the material but it also…
Apart from regulatory requirements, labelling of pharmaceutical products is required for identifying the content of drug, for providing administration instruction, storage requirement, expiry of the drug product etc. Labels should be able to provide essential and comprehensive information to patients…
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