FDA - GMP, GLP, GxP
Good Variable Practice (GxP) is the regulation and quality guideline set to ensure the safety and quality processes for life science products. These standards were formulated by the Food and Drug Administration (FDA) to cover a variety of compliance activities. The x standing for variable can represent different applications of the standard. Other applications that can represent x are M for Manufacturing (GMP) and L for Laboratories (GLP).
Good Manufacturing Practice (GMP) are guidelines recommended to businesses that control the manufacturing of products such as drugs, medical devices, active pharmaceutical ingredients etc. GMP guidelines ensure the businesses manufacturing processes as well as products meet all quality and safety measures.
Good Laboratory Practice (GLP) are FDA set standards for non-clinical laboratory tests and studies conducted for assessing the safety and effectiveness of products. GLPs define the framework for a non-clinical study and state how studies should be performed, evaluated, and reported.
Why should my business use GxPs?
GxP guidelines ensure that organizations comply with standard processes across all applications. These guidelines are familiar across all countries ensuring consistency as well as hold focus on the areas of traceability, accountability, and data integrity. Traceability ensures businesses the capability to reverse engineer products through development history. Accountability identifies individual contributions to the overall process and product development. Data integrity ensures data quality and reliability within businesses.
What are the benefits of GxPs?
Good practice regulations ensure that regulated industries manufacture products that are safe and meet strict quality standards throughout the production process. Becoming GxP compliant improves businesses processes internally as well as externally. When businesses showcase GxP compliance they are exhibiting to clients and other industry figures their dedication to product quality and client satisfaction.
Are GxPs required by any standards or regulations?
FDA regulations have set requirements for regulated industries to ensure quality products and processes. Different industries like manufacturing and laboratories will find they need to comply with industry specific standards. These regulations see a lot of crossover with other quality standards and accreditations such as ISO 13485 To ensure your business is in full compliance with your industry specified GxP, third party professionals can aid through compliant audit services.
How can Labtopia help your business achieve or maintain GxP compliance?
Labtopia’s GxP Services include:
- Medical Device GMP Audits & Gap Assessments
- Quality System Standard Operating Procedures
- Part-time Quality Assurance Support
- IPEC GMP Gap Assessments
- IPEC GMP Audits
- Development of IPEC GMP Quality Systems
- Independent Third-Party GMP/GLPAudits
- Preparation for Third-Party Certification (IPEA, USP-Verified)
- IPEC GMP Training
- EFfCI Audits and GAP Assessments
- EXCiPact Audits and GAP Assessments
- ISO 13485
- Regulatory Consulting Services
- Technical Writing Services
- Process Validation Protocols
- Software Validation Protocols
- Quality Systems Procedures
- Operations Procedures
- Good Manufacturing Practices
- GMP Laboratory Fundamentals
- Laboratory Controls in the GMP/GLP Environment