Quality Assurance Department
Quality Assurance (QA) is a wide concept and covers all aspects that could have an impact on the quality of pharmaceutical products. It can be said that Pharmaceutical quality assurance is the sum of all activities and responsibilities required to ensure that the medicine that reaches the patient is safe, effective, and acceptable to the patient. The objectives of QA are:
- To ensure that the medicine competently provides the desired effect to the person taking it,
- To protect patients from accidentally being administered an incorrect or contaminated medication, and
- To ensure medicines comply with the regulation.
In Simca we have Quality assurance department having independent identity.
Some of the activities to be performed and controlled by Quality Assurance department:
- Ensures that products are formulated and developed in accordance with quality assurance principles.
- Sets up procedure for implementation of cGMP.
- Identifies all management responsibilities, with written job descriptions and organization diagrams.
- Provides SOPs for all manufacturing, cleaning and testing methods.
- Ensures up-to-date written procedures for the supply and control starting and packaging materials.
- Ensures that no products are released for distribution until finally checked by QA personnel.
- Ensures that appropriate conditions are provided for storage and distribution.
- Ensures the self-inspection processes are available and implemented.
- Performs validation of Vendor, Equipment, manufacturing process, system and cleaning process as per the Validation Master Plan.
- Approves and controls Master formulation record and Batch manufacturing record.
- Provides training to all the staffs.
- Ensures the procedure for self-inspection and quality audit.
- Diminishes risks that cannot be controlled by testing of products.