GxP reference the legal requirements for the application of quality assurance and control principles and standards that must be followed for drug manufacturing.
For example, GMP reference the legal requirements for the application of quality assurance and control principles and standards that must be followed for drug manufacturing. The GMPs are covered in the Code of Federal Regulations that is applicable to the manufacturing area - 21 CFR Parts 210 and 211. These regulations are currently is the process of being revised under a new initiative called “GMPs for the 21st Century.”
The purpose of this new initiative is two fold: first to ensure that regulatory inspections are based on state-of-the-art pharmaceutical science, and second to encourage the adoption of new technological advances by the pharmaceutical industry, which will include implementing risk-based approaches.
Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP) or GxP are standards for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of laboratories, clinical trials and manufacturing facilities for products that are under the US FDA jurisdiction. Quality System Regulation (QSR) is the Current Good Manufacturing Practice (cGMP)requirements set forth in this regulation for the methods used in the design, manufacture, packaging, labeling, storage, installation and servicing all finizhed devices intended for human use.
