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OTC Drugs: Manufacturing, GMP and Quality Management

The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.

The approval process for drug marketing applications includes a review of the manufacturer’s compliance with the CGMP. FDA assessors and investigators determine whether the firm has the necessary facilities, equipment, and ability to manufacture the drug it intends to market.

This Whitepaper focusses on:

  • Regulations and Standards

  • CGMP or QMS Problems

  • Testing and Validation Methods

  • Non-conformances and CAPA

  • Root Cause Analysis Methodologies

  • Quality Unit

  • Inspection History


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