Quality Assurance Systems
SLC has Quality Assurance System in place that ensures, all components that individually or collectively affect the quality of the product are available, implemented and evaluated.
The QA plays the following roles, namely:
It ensures that products are designed and developed in the right manner to be efficacious, safe and effective. Department is well equipped is involved in research and development of products that are required by the market.
The department has a well equipped laboratory that carries out analysis of the raw materials, intermediate product, finished products, water and environmental monitoring. It sets out specifications and does validation of its analytical methods.
The department ensures that all licenses are renewed. Any regulatory changes are communicated to the different departments for implementation. It registers products with various National Regulatory Authorities in different countries. Apart from the above the department also coordinates and facilitates any external inspections and liaises with other departments to ensure that the corrective actions are implemented.
Quality Assurance coordinates with other departments to ensure that all processes are validated and equipments qualified. It has in place a validation master plan which is used.
All suppliers of materials used in production have to be qualified before they start supplying. Quality Assurance ensures that the manufacturers of raw materials meet certain requirements and the materials meet the required standards. This is done through a vendor qualification system.
All personnel working at various stages of manufacturing undergo continuous training. This is ensured by the quality assurance by drawing of a training calendar and coordinating to ensure that this is implemented.
A sanitation program is drawn and monitored by the quality assurance. All cleaning procedures are approved and validated. Personnel undergo required medical checkups.
All in process checks are done by Quality Assurance Department independent of the Quality Control department. This involves; Sampling testing and release of the raw and packaging materials, intermediate and finished products. Line clearance of the areas and equipment used for manufacturing prior to starting of any process.
All processes are clearly outlined in documents that are controlled by the Quality Assurance Department. These documents include Standard Operating Procedures, Quality Manual, Site Master File, Vendor Qualification Manual, Validation Master Plan etc.
This is done after reviewing of the relevant documentation from the production and quality control together with review of the quality systems.