Objectives:

Quality control is a set of procedures intended to ensure that a manufactured product complies with a defined set of acceptance criteria.

  1. To follow or establish the quality standards.
  2. To discover the flaws or variations in the Starting materials and the manufacturing processes in order to ensure smooth and uninterrupted production.
  3. To undertake all steps which are required to achieve the desired quality of the product.

Responsibilities:

The main functions of QC are to assure that following are implemented throughout the product life cycle.

  1. Testing and release of raw materials, packaging materials, intermediate products and finished products as per these written and approved procedures.
  2. To conduct the stability studies of all products.
  3. Preparation of all the Specifications, Analytical Method Validation, Certificates and Sampling Procedures for Raw Materials, Packaging Materials, In-process products and finished products.
  4. Calibration of the analytical instruments and equipment at suitable intervals in accordance with an established written procedure, schedule, limits of accuracy and precision.
  5. Preparation and periodic review of SOPs, and protocols.
  6. To provide analytical support for process validations, cleaning validations, vendor validation, validation of area and environment.
  7. To report, investigate and record Out of Specifications / Out of Trend.
  8. Quality control plays an active role in validation activities and provides analytical support for process and cleaning validation samples.
  9. Microbiology department shall monitor the microbial contamination of purified water, potable water and environmental monitoring of product process areas and personal hygiene monitoring. Validation of disinfectants used in production.
  10. Microbiology Department are responsible for Microbial limit test for non-sterile products and raw materials (acc. to current pharmacopeia).