- The main objective of Quality assurance is to assure the Identity, Strength, Safety, Purity and Efficacy of the medicinal product.
- “Quality assurance” is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use. Quality assurance therefore incorporates Good manufacturing practices (GMP) and other factors, including product design and development.
– The main functions of QA are to assure that following are implemented throughout the product life cycle.
1. Product Design Control:
- Pharmaceutical products are designed and developed in a way that takes account of the requirements of GMP and other associated codes such as those of good laboratory practice (GLP) and good distribution practices (GDP).
2. Document Control:
- Production and quality operations are clearly specified in a written form and GMP requirements are adopted.
- All processes are carried out as per well-defined and approved procedures.
- Documentary evidence is maintained for each step as per regulatory requirements.
- Develop, review and approve Standard Operating Procedures (SOP’s) which meet the regulatory standards.
- Control of all documents as originals and copies all over the site to facilitate documents traceability and tracking.
3. Human Resources:
- Managerial responsibilities are clearly specified in job descriptions.
- Ensure training of personnel is current with respect to Quality System requirements and promote Best-In-good manufacturing practices.
4. Production Control:
- Arrangements are made for the manufacture, supply and use of the correct starting and packaging materials.
- All necessary controls on starting materials, intermediate products, and bulk products and other in-process controls, calibrations, and validations are carried out.
- The finished product is correctly processed and tested according to the defined in-process-control procedures.
- Review preventative maintenance and/or daily cleaning of equipment, machines, premises & work areas are performed
5- Finished Product Release Procedures:
- Pharmaceutical products are not sold or supplied before the authorized persons have certified that each production batch has been produced and controlled in accordance with the requirements of the marketing authorization and any other regulations relevant to the production, control and release of pharmaceutical products
6- Good Storage/distribution Practice implementation:
- Satisfactory arrangements exist to ensure, as far as possible, that the pharmaceutical products are stored, distributed, and subsequently handled so that quality is maintained throughout their shelf-life.
7. Self-inspection and/or quality audit
- There is a procedure for self-inspection and/or quality audit that regularly appraises the effectiveness and applicability of the quality assurance system and compliance to GMP guidelines.
- Deviations from GMP guidelines are reported, investigated and recorded.
8- Product Quality Review
- Regular evaluations of the quality of pharmaceutical products are conducted with the objective of verifying the consistency of the process and ensuring its continuous improvement.
9- Validation /Qualifications
- Validation /qualifications of all factors contributing towards achieving quality goals are performed, such as Premises, equipment, processes, Utilities, Software ,analytical methods etc.
- There is a system for approving changes that may have an impact on product quality.(Change Control Procedures)