🇺🇸 Live Pharmaceuticals & Life Sciences

FDA 21 CFR 211 — Current Good Manufacturing Practice for Finished Pharmaceuticals

Establishes current good manufacturing practice requirements for finished pharmaceutical products in the US.

View official source document

Rules extracted

245

Obligations decomposed

22.3x

Avg obligations per rule

🇺🇸 United States

Jurisdiction

About this regulation

21 CFR Part 211 establishes the minimum current good manufacturing practice (CGMP) requirements for the preparation of drug products for administration to humans or animals. The regulation covers organization and personnel, buildings and facilities, equipment, control of components and containers, production and process controls, packaging and labeling, holding and distribution, laboratory controls, records and reports, and returned and salvaged drug products. These regulations apply to all manufacturers, processors, packers, and holders of finished pharmaceutical products.

What AuditDSS covers

Source

Regulation

Extracted

Rules

Decomposed

245

Obligations

22.3x

Decomposition ratio

Each rule is decomposed into an average of 22.3 atomic obligations — the smallest testable units that can be independently violated.

Fully extracted & scored

All 245 obligations have been decomposed, titled, risk-scored, and embedded for semantic matching.

Risk scoring

Every obligation in 21 CFR 211 (CGMP) is scored across independent risk dimensions:

Obligation Weight

How critical within the regulatory framework

Violation Likelihood

How often breached in practice

Enforcement Evidence

Regulator enforcement history and penalties

Cascade Dependency

How many obligations depend on this one

Regulatory details

Full title: FDA 21 CFR 211 — Current Good Manufacturing Practice for Finished Pharmaceuticals
Regulatory body: Food and Drug Administration
Jurisdiction: 🇺🇸 United States
Document type: regulation
Effective date: September 29, 1978
Issuing authority: U.S. Food and Drug Administration (FDA)
Industry: Pharmaceuticals & Life Sciences
Official source: View source document ↗

Who this applies to

drug manufacturersdrug processorsdrug packersdrug holdersdrug distributors

Key requirements

quality control unit authority
personnel qualifications and training
building and facility standards
equipment maintenance and calibration
component and container controls
production and process controls
packaging and labeling controls
laboratory testing and stability
records and reports
returned and salvaged product handling

Frequently asked questions about 21 CFR 211 (CGMP)

What is 21 CFR 211 (CGMP)?

Who does 21 CFR 211 (CGMP) apply to?

21 CFR 211 (CGMP) applies to drug manufacturers, drug processors, drug packers, drug holders, drug distributors.

How many obligations does 21 CFR 211 (CGMP) contain?

AuditDSS has decomposed 21 CFR 211 (CGMP) into 245 atomic obligations from 11 rules. Each obligation is independently testable and risk-scored.

What are the key requirements of 21 CFR 211 (CGMP)?

The key requirements include: quality control unit authority, personnel qualifications and training, building and facility standards, equipment maintenance and calibration, component and container controls, production and process controls, packaging and labeling controls, laboratory testing and stability, records and reports, returned and salvaged product handling.

How can I assess my 21 CFR 211 (CGMP) compliance?

Upload your compliance policy to AuditDSS. The platform maps your document against all 245 21 CFR 211 (CGMP) obligations using deterministic AI scoring — not checklists or LLM summaries. You get a risk-scored gap analysis showing exactly which obligations are covered, partially covered, or missing.

Which jurisdiction enforces 21 CFR 211 (CGMP)?

21 CFR 211 (CGMP) is enforced in United States by Food and Drug Administration.

When did 21 CFR 211 (CGMP) come into effect?

21 CFR 211 (CGMP) became effective on September 29, 1978.

What industry does 21 CFR 211 (CGMP) apply to?

21 CFR 211 (CGMP) is primarily relevant to the Pharmaceuticals & Life Sciences industry. AuditDSS covers 68 regulations in this industry sector.

Build a 21 CFR 211 (CGMP) compliance pack

Don't have a compliance policy yet? AuditDSS generates a complete compliance pack for 21 CFR 211 (CGMP) — alone or combined with other regulations your business needs. Every clause is mapped to specific obligations.

Policy

High-level commitments and governance framework covering 21 CFR 211 (CGMP) requirements.

Procedures

Step-by-step operational procedures to implement each policy commitment.

Forms & checklists

Ready-to-use forms, registers, and checklists for day-to-day compliance operations.

Multi-regulation

Combine 21 CFR 211 (CGMP) with other regulations into a single unified compliance pack for your business.

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Upload your document

Upload your compliance policy, program manual, or operational document. AuditDSS accepts any text-based document.

AI maps against 245 obligations

Your document is scored against every obligation in 21 CFR 211 (CGMP). Each claim is mapped to the obligation tree and evaluated for coverage.

Risk-scored gap report

Receive every gap ranked by risk priority with remediation guidance, enforcement evidence, and cascade impact analysis.