Current Good Manufacturing Practices
Current Good Manufacturing Practices (cGMPs) are regulations enforced by the FDA. CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Pharmaceutical and biotechnology laboratory companies follow cGMPs to ensure their items are manufactured to specific requirements including identity, strength, quality, and purity. Compliance is regulated by the FDA. There are several federal regulations that relate to current good manufacturing practices which, if not followed, can lead to criminal penalties. There are two specific regulations that relate to pharmaceutical laboratory manufacturers, one for biological products, and a regulation that monitors electronic records, counterparts, and electronic signatures. In an excess of caution, some companies have opted to adopt practices, procedures, and risk management systems that go above and beyond CGMP regulations.
One of the most critical components of current good manufacturing practices and for facility accreditation is quality control – the process of sampling, testing, and comparing results with pre-agreed specifications as part of the overall quality assurance process. A well-designed quality control system does not focus simply on finished product testing but utilizes the most appropriate analytical techniques to assure the quality of materials throughout the process. Current good manufacturing practices help to ensure the consistent quality and safety of products by focusing attention on five key elements, which are often referred to as the 5 P’s: people, premises, processes, products, and procedures (or paperwork). And if all five are done well, there is a sixth P … profit!
CGMP Implementation
Implementing CGMPs as early as possible helps protect the safety of clinical trial participants and provides a foundation for a robust quality management system (QMS) necessary for facility accreditation. Early adoption of quality systems allows for a gradual integration of processes, which is less burdensome on the organization. In addition, facility accreditation and early adoption will ensure tighter controls, build a culture of quality, and minimize the risks of noncompliance. This will benefit the organization as it moves toward commercialization and help to assure a successful pre-approval inspection.
Sponsor companies should also have a QMS. If the sponsor is also the manufacturer, they will need a QMS addressing all requirements in the CGMPs. If a sponsor outsources the manufacturing of their product, they are still responsible for ensuring the contracted vendor(s) has a robust QMS with facilities, systems, and processes that are fit for purpose.
Complying with CGMP throughout the process helps ensure the quality of investigational products, which helps protect clinical trial subject safety and reduces variability due to poor quality. Even if manufacturing has been outsourced, sponsors are still responsible for ensuring CGMP requirements are met.
Author Information
German A. Rodriguez has over 15 years of quality management experience in laboratory and biologics sectors. German Rodriguez has received his Total Quality Management certificate. He has extensive experience in quality assurance, regulatory compliance, FDA Adverse Event Reporting, FDA Product Deviation Reporting, FDA 483’s, cGTP’s, infection control, certified ISO Class 5, 7, 8 inspection and maintenance, QIC and auditing.
American Association of Quality Facilities (AAQF) is a global facility accreditation organization. AAQF offers accreditation to healthcare facilities, laboratories, and manufacturing facilities. AAQF helps organizations that follow cGTP, cGMP, cGLP, and cGCP standards to achieve the highest quality of standards.
The opinions and statements in this blog are those of the authors and do not necessarily reflect those of AAQF. This blog is based on personal experience and reviews of information publicly available or identified in other database searches.
