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 ...