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Pharmaceutical Analysis
book

Pharmaceutical Analysis

by P. D. Chaithanya Sudha
July 2012
Intermediate to advanced content levelIntermediate to advanced
758 pages
17h 12m
English
Pearson India
Content preview from Pharmaceutical Analysis

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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Publisher Resources

ISBN: 9789332515659