Objectives:

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 current Good manufacturing practices (cGMP) and other factors, including product design and development.

Responsibilities:

  1. The main functions of QA are to assure that following are implemented throughout the product life cycle.
  2. Pharmaceutical products are designed and developed in a way that takes account of the requirements of cGMP and other associated codes such as those of good laboratory practice (GLP) and good distribution practices (GDP).
  3. Establishing the system required for compliance with cGMP and international regulatory requirements &/or standards.
  4. Arrangements are made for the manufacture, supply and use of the correct raw and packaging materials.
  5. Supervision of the materials dispensing, in-process checking and sampling as per the Master Production Records.
  6. All the manufacturing stages are inspected and controlled by QA. Records of all the results of inspection and that of testing of raw materials, in-process materials and finished products are formally checked against approved specification.
  7. Cooperating with production department, research & development (R&D) department & QC department in matters concerning introduction of new products, such as quality aspects, process validation and cleaning validation.
  8. Pharmaceutical products are not sold or supplied before the authorized persons have certified that each production batch has been produce, analyzed 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.
  9. On-job training, evaluation & motivation of subordinates in quality assurance department. Administering training on safety, cGMP and system SOPs.
  10. Responsible for the product recall system as well as customer complaint system.
  11. There is a procedure for internal audits, vendor audits, product quality reviews, complaints investigation and monitoring change control that regularly appraises the effectiveness and applicability of the quality assurance system.
  12. There is a system for approving changes that may have an impact on product quality.
  13. 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.
  14. Documentary evidence is maintained for each step as per regulatory requirements.
  15. Validation /qualifications and calibration of all factors contributing towards achieving quality goals are performed, such as Premises, equipment, processes, Utilities, etc.
  16. Approval of Protocols for IQ, OQ, PQ of equipment and process qualification.