Organisational Structure

Quality Control is part of GMP and GMP is part of Quality Assurance, it means Quality Assurance in-corporating GMP and Quality Control. The concept of quality assurance, GMP and quality control are interrelated aspects of quality management.

Procedures And Process-Quality Assurance is a wide ranging concept covering all matters that individually or collectively influence the quality of the products. It is the totally of arrangements made with the object of ensuring that pharmaceuticals products are of the quality required for their intend use.

The system of quality assurance appropriate to the manufacture of pharmaceutical products should ensure that:
  • Production and control operations are clearly specified in a written from and GMP requirements are adopted; Managerial responsibilities are clearly specified in job descriptions;
  • Satisfactory arrangements exist to ensure, as far as possible, that the pharmaceutical products are stored by the manufacturer, distributed, and subsequently handled so that quality is maintained throughout their shelf-life;
  • There is a procedure for self-inspection and/or quality audit that regularly appraises the effectiveness and applicability of the Quality Assurance system; Deviations are reported, investigated and recorded;
  • Arrangements are made for the manufacture, supply and use of the correct starting and packaging materials;
  • The finished product is correctly processed and checked, according to the defined procedures;
  • Pharmaceutical products are not sold or supplied before released by Authorized Person.
  • Regular evaluations of the quality of pharmaceuticals products.
All necessary resources are provided it is ensured by QA, including:
  • Appropriate qualified and trained personnel
  • Adequate premises and space
  • Suitable equipments and service
  • Appropriate materials, containers & labels
  • Approved procedures and instructions
  • Suitable storage and transports
  • Adequate personnel, laboratories and equipment for in- process control

Systematic actions are necessary to ensure adequate confidence that a product (or service) will satisfy given requirements for quality. The totality of these actions is termed "Quality Assurance".