Quality Systems Implementation

Quality Management Systems for the pharmaceutical industry stem from key regulations that the FDA enforces such as 21 CFR Part 211. Under this regulation, a quality management systems definition would necessarily cover the concept of a quality control unit, which is responsible for overall quality management systems. The quality control unit is primarily responsible for documentation (procedures, SOPs, policies, etc.) and control of all documents that impact product quality and safety. In addition to 21 CFR Part 211, the FDA guidance called “Pharmaceutical cGMPs for 21st Century–A Risk-Based Approach” provides principles and standards that will help pharmaceutical companies establish an organizational QMS definition. This guidance offers a quality systems model and shows how manufacturers can comply fully with 21 CFR Part 211. The ICH Q10, a harmonized guidance for the pharmaceutical industry offers a model QMS based on ISO concepts and principles on Good Manufacturing Practices.

For medical device companies, the Quality System Regulation (21 CFR 820) offers a solid basis for a quality management systems. It is the primary FDA regulation for medical device companies. In as much as it helps manufacturers create their own organizational QMS definition, the regulation offers enough leeway for individual companies to define their priorities based on the device they are manufacturing. Most medical manufacturers also adhere to ISO 13485, which similarly provides a quality management systems definition. The FDA has harmonized QSR with ISO standards, making them complementary. Both QSR and ISO 13485 require the establishment of a quality management system that encompasses many quality processes, such as document control, training control, corrective action and preventive action (CAPA), and audit management processes.