Quality Assurance is a planned and systematic activities implemented within quality system that can be demonstrated to provide confidence that a product or service will fulfill requirements for quality. It is a system for evaluating performance, service, quality of a product against system, standard or specified requirement for customers.
It is a good practice in manufacture of pharmaceutical products, as it is the process of vouching for integrity of products to meet standards for proposed use. It is an obligation that ensures manufacturers meet the needs of end-user needs in terms of safety, efficacy, quality, strength, reliability and durability. To attain quality in products objectives of quality assurance is to be meet following the principles of quality assurance.
Quality assurance is needed in Pharmaceutical products as:
- Surge of substandard, fake and adulterated medicine is global threat.
- Helps to set and maintain quality standards by preventing problems to begin with. Thus, prevents brand and reputation damage as well as higher productivity.
- The system of specifications as well as practice control measures in the industry, which is also referred to as standard operating procedures (SOPs) that are designed by regulatory authorities and scientific community to ensure good manufacturing practice.
- Stringent, scientific, systematic and sustainable approach to commercial drug production ensures protection of public health.
- It allows them to reduce extra costs that come with retesting, replacing and reselling faulty goods. It might even save a cost in legal expenses, especially if product isn’t up to industry standards.
The system of quality assurance appropriate to the manufacture of pharmaceutical products should ensure that:
- Pharmaceutical products are designed and developed in a way that takes account of requirements of GMP and other associated codes such as good laboratory practice (GLP) and good clinical practice (GCP).
- Production and control operations are clearly specified in a written form and GMP requirements are adopted.
- Arrangements are made for manufacture, supply and use of correct starting and packaging materials.
- All necessary controls on starting materials, intermediate products, bulk products and other in-process controls, calibrations, and validations are carried out.
- Finished product is correctly processed and checked, according to the defined procedures.
- Pharmaceutical products are not sold or supplied before authorized persons have certified that each production batch has been produced and controlled in accordance with the requirements of marketing authorization and any other regulations relevant to production, control and release of pharmaceutical products.
- Satisfactory arrangements exist to ensure, as far as possible, that products are stored by manufacturer, distributed, and subsequently handled so that quality is maintained throughout their shelf-life.
- Procedure for self-inspection and/or quality audit that regularly appraises effectiveness and applicability of quality assurance system.
- Regular evaluations of quality of pharmaceutical products should be conducted with an objective of verifying consistency of process and ensuring its continuous improvement.
- Any deviations are reported, investigated and recorded.