21 CFR Part 58 - Good Laboratory Practice (GLP) vs 21 CFR Part 211 - Current Good Manufacturing Practice
What is the difference between 21 CFR Part 58 - Good Laboratory Practice (GLP) and 21 CFR Part 211 - Current Good Manufacturing Practice?
21 CFR Part 58 - Good Laboratory Practice (GLP) is a other framework applying in the United States, with 31 controls across 7 domains. 21 CFR Part 211 - Current Good Manufacturing Practice is a other framework applying in the United States, with 78 controls across 21 domains. Both govern the same subject, so their requirements overlap; the mapping below shows which controls carry across and which are asked for by only one of them.
21 CFR Part 58 - Good Laboratory Practice (GLP)31 controls
21 CFR Part 211 - Current Good Manufacturing Practice78 controls
Questions people ask about 21 CFR Part 58 - Good Laboratory Practice (GLP) and 21 CFR Part 211 - Current Good Manufacturing Practice
What is the difference between 21 CFR Part 58 - Good Laboratory Practice (GLP) and 21 CFR Part 211 - Current Good Manufacturing Practice?
21 CFR Part 58 - Good Laboratory Practice (GLP) has 31 controls while 21 CFR Part 211 - Current Good Manufacturing Practice has 78 controls. Both frameworks address compliance requirements but differ in scope, focus, and applicability. Use our platform to explore the exact control-to-control mappings.
Do I need both 21 CFR Part 58 - Good Laboratory Practice (GLP) and 21 CFR Part 211 - Current Good Manufacturing Practice?
Whether you need both depends on your industry, regulatory requirements, and customer expectations. Many organizations implement multiple frameworks simultaneously. Our compliance platform helps you map controls between 21 CFR Part 58 - Good Laboratory Practice (GLP) and 21 CFR Part 211 - Current Good Manufacturing Practice so you can identify shared requirements and avoid duplicate effort.
How do 21 CFR Part 58 - Good Laboratory Practice (GLP) and 21 CFR Part 211 - Current Good Manufacturing Practice controls map to each other?
Our platform maps controls between 21 CFR Part 58 - Good Laboratory Practice (GLP) and 21 CFR Part 211 - Current Good Manufacturing Practice at a granular level. Each mapping shows whether controls are fully aligned, partially aligned, or represent gaps. This helps you prioritize implementation when pursuing both frameworks.
Which framework should I implement first, 21 CFR Part 58 - Good Laboratory Practice (GLP) or 21 CFR Part 211 - Current Good Manufacturing Practice?
The best starting point depends on your specific regulatory requirements, industry, and customer demands. Consider which framework is most urgently required by your stakeholders or regulators. Use our free compliance platform to run a gap analysis and determine the optimal implementation sequence.
Each framework on its own
Comparisons people read next
Each of these compares one of the two standards above against another it shares controls with.
21 CFR Part 58 - Good Laboratory Practice (GLP) vs UK Gambling Commission - Cyber Resilience Requirements1 shared control21 CFR Part 58 - Good Laboratory Practice (GLP) vs TISAX - Trusted Information Security Assessment Exchange1 shared control21 CFR Part 58 - Good Laboratory Practice (GLP) vs Protective Security Policy Framework (PSPF) Release 20241 shared control21 CFR Part 211 - Current Good Manufacturing Practice vs FDA Quality Management System Regulation (QMSR)7 shared controls21 CFR Part 211 - Current Good Manufacturing Practice vs Protective Security Policy Framework (PSPF) Release 20244 shared controls21 CFR Part 211 - Current Good Manufacturing Practice vs IEEE 16864 shared controls
See all control mappings with interactive gap analysis
Explore the complete mapping between 21 CFR Part 58 - Good Laboratory Practice (GLP) and 21 CFR Part 211 - Current Good Manufacturing Practice on our compliance platform.
Written and maintained by Gerard Blokdyk, The Art of Service.