Direct comparison
GMP vs. cGMP: Why 'Current' Matters
GMP is the generic term; cGMP (21 CFR 210/211) legally requires current industry practice. See what moved: data integrity, EU Annex 1, CSV.
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How do GMP (generic term), cGMP (FDA's regulatory term) compare side by side?
The table below compares GMP (generic term), cGMP (FDA's regulatory term) across 6 procurement-relevant dimensions, from full name through practical consequence for a quality system.
Side-by-side comparison
| Dimension | GMP (generic term) | cGMP (FDA's regulatory term) |
|---|---|---|
| Full name | Good Manufacturing Practice | Current Good Manufacturing Practice |
| Where it's codified | WHO GMP guidelines; ICH Q7 (APIs); EU EudraLex Volume 4 | US 21 CFR Parts 210 and 211 (drugs); Part 820/QMSR (devices) |
| What the term implies about time | A quality-system standard, not explicitly tied to a moving baseline | Compliance is measured against current industry practice, not the practice in force at validation |
| Can a compliant procedure become non-compliant with no rule change? | Not built into the term itself | Yes — this is the specific legal effect of "current"; the standard moves even when the regulatory text doesn't |
| How FDA operationalizes it | Not an FDA enforcement term as such | Inspection findings (Form 483, Warning Letters) cite current guidance and current industry practice, e.g. the 2018 CGMP data-integrity guidance |
| Practical consequence for a quality system | Follow the written, approved procedure | Follow the written procedure AND actively monitor whether "current" practice has moved past it (new annexes, new FDA guidance, revised ICH text) |
Common questions
Common questions about GMP (generic term) vs cGMP (FDA's regulatory term)
Is cGMP a different standard from GMP, or the same one?
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The underlying goal is the same — controlled, documented, quality-assured manufacturing. "GMP" is the term WHO, ICH, and EU guidance use for that goal generally. "cGMP" is FDA's specific US regulatory term (21 CFR Parts 210/211), where the word "current" is legally operative: it requires ongoing conformance to evolving industry practice, not a one-time compliant state.
Can a facility be cited for something that was compliant when it was implemented?
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Yes. That is the entire function of the word "current" in cGMP. FDA inspects against current industry practice and current guidance, not the practice in force when a given SOP, validation, or facility design was originally approved.
Does this apply outside the US?
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The specific "current" framing is a US (FDA/21 CFR) legal construction. WHO GMP and EU GMP use "GMP" without the "c," but both frameworks are revised periodically and inspectors in those systems likewise assess against the current version of the applicable annex or guideline — the practical effect is similar even though the term differs.
