Current Regulations and Quality Standards

Roles of pharmaceutical inspection convention and co-operation scheme (PIC/S) are to improve co-operation in the field of Good Manufacturing Practices between regulatory authorities and the pharmaceutical industry. The FDA regulations and CFR are responsible for protecting and promoting public health through the regulation and supervision of all the products available in the market to ensure patient compliance. EU-GMP guidelines are needed to maintain the quality which is stricter when compared to WHO-GMP guidelines.

  • Roles of pharmaceutical inspection convention and co-operation scheme (PIC/S)
  • FDA-GMP regulations and CFR
  • EU-GMP regulations (European union-GMP regulations)
  • Canadian GMP regulations
  • Japan GMP regulations
  • International regulatory affairs
  • Imporatnce of audit in pharmaceutical industry

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