Quality as main criteria in a pharmaceutical production requires to comprehensively implementation of pharmaceutical management system which complies with ICH Q7,8,9 & 10, PIC/S protocols and requirements. Different aspects such as Quality assurance, GXP principles, Quality control and Risk management are included in QA which shows its wide-ranging concept. Also these parameters can cover all measures and solutions that affect product quality as individual or in group. In addition, by establishing systematic process for identifying, evaluating and managing of potential and existing risks, it can protect the business and maintain the quality of products which continuously developed in order to meet requirements.
QA department ensures that the production processes life cycle is properly managed by implementation optimal manufacturing conditions. As core of quality maintenance in each pharmaceutical factory, QA has main responsibilities in calibration, validation, qualification, technical inspections and maintenance of quality systems which briefly define as follow:
- Validation and Qualification
- Maintenance of quality system