MyRHC Compliance index

FDA

Current Good Manufacturing Practice (CGMP) for Drugs

FDA current good manufacturing practice regulations for drug manufacturing, processing, packing and holding (21 CFR Parts 210 and 211).

Healthcare Biotech & Life Sciences US

At a glance

Short name
CGMP
Issuing / stewarding body
FDA
Jurisdiction
US
Also known as / related labels
FDA 21 CFR Part 210 · FDA 21 CFR Part 211 · FDA 21 CFR Part 213 (medical gases) · ICH Q7 · EU GMP

What this entry covers

Current good manufacturing practice (CGMP) regulations are the US Food and Drug Administration (FDA) minimum requirements for the methods, facilities and controls used to manufacture, process, pack and hold drugs. The core rules for finished pharmaceuticals are 21 CFR Parts 210 and 211, with product-specific parts for other categories.

MyRHC indexes this framework so practitioners, auditors, and automated agents can find the authoritative primary sources in one place. This page is a navigation aid; it is not legal advice and is not a substitute for the official text.

Official documentation

Recent changes

  • 2025-12-18: FDA’s medical gas rule took effect, taking medical gases out of the scope of Part 211 and placing them under medical gas-specific CGMP rules in 21 CFR Part 213. Part 210 still applies. Federal Register eCFR

How to use this index entry

  1. Open the official link above (or the agency home if the deep link drifts).
  2. Confirm edition / revision date against your program scope.
  3. Map applicability by sector and jurisdiction listed in the metadata.
  4. Follow related frameworks only after checking their own official sources.

Disclaimers

  • MyRHC does not host proprietary standards text (ISO, some industry bodies).
  • Where standards are paywalled, we link to the publisher’s catalog page.
  • Always verify current requirements with counsel and the issuing authority.
Index only — not legal advice. MyRHC does not certify compliance. Confirm current requirements with the issuing authority and qualified counsel. Proprietary standards text remains with its publisher.

Same agencies or sectors — still verify each official source independently.

CLIA

Official

Clinical Laboratory Improvement Amendments (CLIA)

Federal quality standards for US laboratories testing human specimens, administered by CMS with CDC and FDA under 42 CFR Part 493.

CMS CDC Clinical Research Healthcare

Common Rule

Official

Common Rule (45 CFR Part 46) and IRB Oversight

HHS regulations at 45 CFR Part 46 protecting human research subjects and governing IRB review, overseen by the Office for Human Research Protections.

HHS OHRP Clinical Research Biotech & Life Sciences

Data Retention

Official

Data Retention and Secure Destruction

Index of US federal sources on records retention and media sanitization, including HIPAA documentation rules, 21 CFR Part 11 and NIST SP 800-88.

HHS FDA Data Management Healthcare

DSCSA

Official

Drug Supply Chain Security Act (DSCSA)

US law setting up electronic, interoperable tracing of prescription drug packages through the supply chain, implemented by the FDA.

FDA Supply Chain Pharma

FDA Part 11

Official

FDA 21 CFR Part 11: Electronic Records and Electronic Signatures

FDA regulation, 21 CFR Part 11, setting criteria under which electronic records and electronic signatures are accepted in place of paper records.

FDA Healthcare Biotech & Life Sciences

FDA AI-Enabled Devices

Official

FDA Artificial Intelligence-Enabled Medical Devices

FDA guidance and resources for medical devices with AI-enabled software functions, including predetermined change control plans (PCCPs).

FDA AI & Machine Learning Medtech