Quality assurance is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product.
It is totality of arrangements made with an object of ensuring that products are of quality required for their intended use. Quality assurance therefore incorporates GMP and other factors, including those outside scope of this guide such as product design and development. Appropriate quality assurance in the pharmaceutical industry is very important.
QA has two main objectives
- To ensure the delivery of quality.
- To demonstrate efforts of service providers to provide best possible results.
However, it exists to serve a number of objectives which are:
- Manage good manufacturing practices (GMP).
- Manage good laboratory practices (GLP).
- Maintain and manage a safety programme.
- Assure quality of raw materials.
- Assuring quality and traceability of finished product.
- Evaluating plant environment.
- Developing an HACCP plan.
- To offer a guarantee that the person who is using the product (e.g. Medicine) is confident that every unit will achieve the desired effect.
- To protect users for products from possible accidental defect in manufacture, design, storage as well as usage instructions.
- To ensure that law is complied with to accidental effects of products.
- To offer protection of manufacturing organization.
Attainment of these objective is responsibility of senior management and requires participation and commitment of staff in many different departments and at all levels within the company, company’s suppliers, and distributors.
To achieve objectives reliably there must be a comprehensively designed and correctly implemented system of quality assurance incorporating Good Manufacturing Practice and quality control following the principles of quality assurance. It should be fully documented and monitored for its effectiveness. All parts of the quality assurance system should be adequately staffed with competent personnel, and should have suitable and sufficient premises, equipment, and facilities.