Quality Assurance in Pharmaceuticals

Quality Assurance:

•Quality Assurance includes Quality Control, and is the overall activity of ensuring that all aspects of products manufacture and release for sale are carried out to GMP requirements and conform to registered specifications.

•Reviewing/Authorizing procedures

•Checking documentation

•Auditing processes

•Products designed to meet GMP/GLP

•Production & controls clearly defined

•Products & procedures fully checked prior to release to market

•Arrange for supply of correct raw/packaging materials

•Control of validation, in-process controls & intermediates

•Finished products processed & checked to defined procedures

•Products produced to controlled and defined procedures

•Defined responsibilities

•Product stored, handled & distributed so that quality is maintained