Objectives:
Quality control is a set of procedures intended to ensure that a manufactured product complies with a defined set of acceptance criteria.
- To follow or establish the quality standards.
- To discover the flaws or variations in the Starting materials and the manufacturing processes in order to ensure smooth and uninterrupted production.
- 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.
- Testing and release of raw materials, packaging materials, intermediate products and finished products as per these written and approved procedures.
- To conduct the stability studies of all products.
- Preparation of all the Specifications, Analytical Method Validation, Certificates and Sampling Procedures for Raw Materials, Packaging Materials, In-process products and finished products.
- Calibration of the analytical instruments and equipment at suitable intervals in accordance with an established written procedure, schedule, limits of accuracy and precision.
- Preparation and periodic review of SOPs, and protocols.
- To provide analytical support for process validations, cleaning validations, vendor validation, validation of area and environment.
- To report, investigate and record Out of Specifications / Out of Trend.
- Quality control plays an active role in validation activities and provides analytical support for process and cleaning validation samples.
- 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.
- Microbiology Department are responsible for Microbial limit test for non-sterile products and raw materials (acc. to current pharmacopeia).