GxP
Good Practice Regulations (GMP, GLP, GCP)
FDA and international regulations ensuring quality and safety in pharmaceutical, medical device, and clinical research.
What is GxP?
GxP is a general abbreviation for Good (x) Practice quality guidelines and regulations. The "x" represents the specific field: GMP (Good Manufacturing Practice), GLP (Good Laboratory Practice), GCP (Good Clinical Practice), GDP (Good Distribution Practice), and others. These regulations ensure that products are safe, meet quality requirements, and that clinical trials are conducted ethically.
GxP regulations are enforced by FDA in the US and equivalent agencies globally (EMA, MHRA, PMDA, etc.). Compliance requires implementing quality systems, documentation practices, personnel training, facility controls, and validation appropriate to the specific GxP discipline.
Who Needs GxP?
- Pharmaceutical manufacturers (GMP)
- Preclinical testing labs (GLP)
- Clinical trial sponsors and sites (GCP)
- Medical device manufacturers
- Pharmaceutical distributors (GDP)
Key Requirements
Core compliance areas for GxP
Quality System
Establish and maintain quality management system appropriate to activities.
Documentation
Maintain complete, accurate documentation of all GxP activities.
Personnel Qualification
Ensure personnel are trained and qualified for their responsibilities.
Facility and Equipment
Maintain facilities and equipment in qualified, controlled state.
Validation
Validate processes, methods, and computerized systems.
Benefits of GxP Compliance
- Regulatory approval for products
- Patient safety protection
- Product quality assurance
- Market authorization
- Global regulatory acceptance
- Foundation for life sciences operations
Official Resources
Related Frameworks
21 CFR Part 11
FDA regulations establishing criteria for electronic records and signatures in pharmaceutical and medical device industries.
ISO 27001
The international standard for information security management systems (ISMS).
HIPAA
Federal law protecting sensitive patient health information from disclosure.