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Pharmaceutical Analysis by P. D. Chaithanya Sudha

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Chapter 1

Quality Assurance and Regulatory Affairs

QUALITY ASSURANCE (QA)

Quality assurance is a wide ranging concept that covers the factors with influence the quality of a product. QA incorporates good manufacturing practice (GMP) and other factors. QA system is to ensure the following:

  • Pharmaceutical products are designed and developed in a way that they followed the GMP, good laboratory practice (GLP), etc. Production and control operations are clearly specified in a written form and GMP requirements are adopted.
  • Managerial responsibilities are clearly specified in job description.
  • Arrangements are made for the manufacture, supply and use of correct starting and packing materials.
  • All necessary controls on starting materials, intermediate ...

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