Current Good Manufacturing Practice (CGMP)

Key facts

Statutory basis

FD&C Act Section 501(a)(2)(B), the adulteration provision

Finished drug regulations

21 CFR Parts 210 and 211

Device regulation

21 CFR Part 820, the Quality Management System Regulation

Enforced through

Inspections, Form 483s, warning letters, import alerts and recalls

What is Current Good Manufacturing Practice?

CGMP rules require manufacturers to build quality into how a product is made rather than relying on testing finished product alone. They cover facility design, equipment qualification, raw material testing, process controls, batch records, laboratory controls, complaint handling and investigation of failures.

The word current matters. The rules describe what must be achieved more than exactly how, and the Food and Drug Administration (FDA) expects firms to use methods and controls that keep pace with scientific and technical progress.

Under the Federal Food, Drug, and Cosmetic Act, a drug made without CGMP compliance is legally adulterated. That does not necessarily mean the drug is defective; it means it was not made under conditions that assure its quality, which is enough for FDA to act.

How CGMP requirements are organized

CGMP is a family of requirements rather than one regulation:

Outsourcing facilities registered under Section 503B must also follow CGMP, while traditional pharmacy compounding under Section 503A is exempt from CGMP and largely overseen by state boards of pharmacy.

• Human drugs: 21 CFR Parts 210 and 211 for finished pharmaceuticals; the statutory requirement also applies to active pharmaceutical ingredients.
• Positron emission tomography drugs: 21 CFR Part 212.
• Biologics: drug CGMP requirements plus biologics-specific rules, such as 21 CFR Part 606 for blood and blood components.
• Medical devices: 21 CFR Part 820, which since February 2026 incorporates the international standard ISO 13485:2016.
• Combination products: 21 CFR Part 4.
• Dietary supplements: 21 CFR Part 111; human food: 21 CFR Part 117.

Why CGMP matters

CGMP status is a leading indicator of supply and regulatory risk:

• Supply reliability: manufacturing and quality failures are a common immediate cause of drug shortages and recalls.
• Supplier selection: inspection outcomes, Form 483 observations and warning letters are core inputs when qualifying contract development and manufacturing organizations (CDMOs) and ingredient suppliers.
• Approval timing: serious CGMP problems at a facility can delay approval of applications that rely on it.
• Investment due diligence: an unresolved warning letter or import alert can cut output from a plant and reduce its value.