The Quality Assurance Department, managed by qualified personnel, constantly examines quality aspects at every stage of manufacture. A Comprehensive system ensures that there is total traceability of data right from inflow of material to testing to release, to manufacturing & to dispatch. The documentation system also covers qualification of area, machines & also covers records related to calibration & validation. We assure quality of our products by regularly inspecting the facilities, systems and procedures to meet the current GMP norms. The employees are trained periodically on GMP requirements. We have well defined validation master plan, which ensures smooth functioning of machines and hence the process. We also have a well-defined stability protocol and programme that ensures the velocity of the claimed shelf life. We have a LAN System that facilitates a bi-directional communications with the key departments. This ensures efficient data management. This computer system is designed using validated software and confirms to 21 CFR Part level guidelines.
Quality Assurance (QA) procedures ensure that the quality of the products are maintained by strict compliance with international pharmacopoeias (BP, USP and EP) specifications on raw materials, packaging materials and finished products.
The quality Assurance department assures quality through a well-designed quality management programme. The programme begins with the following:
- Documentation related to product development.
- Development of prototype
- Assessment of prototype
- Evaluation of prototype in terms of quality as well as cost effectiveness.
- Systematic scale and transfer of technology in production.
- Through well-defined testing procedures for incoming raw material and packaging materials.
- Through evaluation of production stages wide in-process quality control test.
- Through testing of final product.
Our company has its own GMP System: