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 ...