Follow
Current Good Manufacturing Practices are defined by the FDA to ensure proper design, monitoring, and control over manufacturing processes and facilities in pharma and other FDA-regulated industries. These systems are designed to help companies ensure the correct identity, strength, purity and quality of drug products
The cGMP system includes a series of controls for quality-oriented operations, including:
=>> Management System
=>> Quality raw material
=>> Operating Procedures
=>> Deviation detection
=>> Deviation investigation
=>> Reliable test
If cGMP is followed, organizations can avoid many common causes of quality failures that threaten patient safety, such as drug contamination, deviations, or mix-ups. The FDA has been very clear that cGMP is designed for flexibility to provide a universal framework for the entire pharmaceutical industry. Also, the guidelines are not a checklist; They are a set of “minimum requirements” for total quality management.
The latest cGMP was published in 2016, Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. This 58-page document provided some excellent updates to previous cGMPs for the industry, but it raised more questions than it answered in the eyes of many pharmaceutical companies. FDA followed up with a Q&A in 2018 to clarify some of the most common questions about the latest guidance. Some of these questions are addressed here, along with insights from pharma industry subject matter experts.
