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.


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

1. Sampling ,testing and release of raw materials and packaging materials.

2. Testing and release of semi-finished and finished products.

3. To conduct the ongoing and validation stability studies .

4. To validate the analytical methods.

5. Preparation and periodic review of SOPs ,Specifications, Certificates ,Methods 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.

8. To qualify and calibrate the instruments.

9. To collect and maintain the control samples of raw materials , Packing Materials and finished products.

10. Environmental monitoring and personal hygiene monitoring.

11.Raw, in process and purified water analysis.

12. To conduct the in vitro dissolution comparative studies for products registration and batch scale up.