Quality Assurance

Quality Assurance Department (QAD) was formed to ensure compliance with the quality policy in every aspect of production and quality control. The QA department confirms that the products are designed and developed according to the GMP and GLP practices to assure quality of products until its shelf life.

Principles of QA System:

  1. Quality Assurance incorporates GMP standard for product design and development.
  2. Wide Range Concept
    • Includes all components that have individual or collective influence on the quality of the product
  3. Totality of the Arrangement
    • To ensure that the drug is of the right quality for the intended use.

Activities of QA:

  • Line clearance of the production equipment
  • Specification of raw material, bulk, intermediate and finished products
  • Sampling of raw materials, bulk, intermediate and finished products
  • Supply of raw material
  • Stability study
  • Documentation and records
  • Master formula instructions
  • Maintenance of Log book, Deviation log book and Site master file
  • Retrospective and concurrent validation
  • In Process Quality Control (IPQC)
  • QC report handling
  • Product recall handling
  • Rejected batch and material handling
  • Self-inspection
  • Annual product review
  • Environmental and water quality analysis
  • Training program

Quality Assurance System (QAS) is developed for a systematic approach to the production of quality products which includes meeting requirements of current GMP standards. Quality Assurance Department is responsible for guaranteeing strict implementation of QAS in accordance with the applicable regulatory guidelines.

The functions to address QAS issues :-

  • Good Manufacturing Practices (GMP) are adopted.
  • Medicinal Products are designed and developed as per the requirements of GMP and GLP.
  • Production and Quality Control Operations are accurately documented.
  • Managerial responsibilities are clearly specified.
  • Arrangements are made for the use and supply of correct raw and packing materials.
  • The finished products are properly processed and checked in accordance to the defined procedures.
  • The products are not sold nor supplied until each batch is certified in accordance with the regulatory requirements by an authorized person.
  • Standard provisions exist to ensure that the products are stored, distributed and handled suitably in order to be well preserved throughout their shelf life.
  • A procedure for self-inspection and/or quality audit appraises the effectiveness and applicability of the Quality Assurance System on a regular basis.
  • The procedures and its various utilities are validated.