“GxP” is defined as “Good-X-Practice,” based on FDA “Predicate Rules”. The X can be filled by “M” to make GMP = Good Manufacturing Practice, by “L” to make GLP = Good Laboratory Practice, by “C” to make GCP = Good Clinical Practice.
GMP: The systems used in quality control laboratories supporting manufacturing operations
GLP: The systems used in laboratories conducting therapeutic value testing to support new product approval . Systems used in laboratories conducting toxicology testing to support new product approval
GCP: The systems used in laboratories that support clinical trials
An IT and/or automated laboratory system:
- “touches” an FDA-regulated product (pharmaceutical, biological, medical device, tobacco, etc.) during the process
- is used to collect, analyze, report, transmit or otherwise process FDA-regulated data
- must be validated in accordance with Agency requirements for Computer System Validation (CSV)
- must be maintained in a validated state through the system’s life cycle
IT and automated “GxP” lab systems can support:
•Development •Toxicology •Clinical Research •Manufacturing •Warehouse Storage •Distribution •Adverse Event Monitoring •Post-marketing Surveillance
GxP Systems Examples:
- Laboratory instrumentation with built-in computer systems
- Systems used to track samples and products, including those that are used in Quality to release them for distribution
- Systems used to verify the identify, integrity, strength, purity, and quality of a material as part of product development
- Laboratory data acquisition systems (LAS)
- Laboratory information management systems (LIMS)
- Clinical data management systems (CDMS)