Quality Assurance is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use. Quality Assurance therefore incorporates cGMP and other factors, including those outside the scope of this guide such as product design and development.
At Pharmasia, the evaluation of raw laboratory data, laboratory procedures and methods, laboratory equipment, including maintenance and calibration, and methods validation data to determine the overall quality of the laboratory operation and the ability to comply with CGMP regulations are being done as per the set SOP (Standard Operating Procedure). The Quality Assurance department is responsible for all types of activities relevant to Quality of the products. Quality Assurance department of Pharmasia limited is divided into 3 (three) separate parts according to the activity distribution:
- Quality Control
- Product Development & Validation
- Quality Assurance
The function of the quality assurance department can be understood and shaped while placing emphasis on the operational aspects. This may be helpful to appreciate the role of quality assurance as including preparation of data for the Qualified Person for the purpose of batch release and certification. In this case, the quality assurance organization would then take up the task of generating portions of batch-related data to ensure they are available through appropriate reporting systems as well as parallel so as to guarantee the functionality of standard quality systems. At Pharmasia, the division of labor between quality assurance, quality control and heads of production involves a hierarchical system practicing the quality circle management in the production floor.