21 CFR Part 210 – Drug Manufacturing cGMP Basics

This topic is part of the SG Systems Global regulatory glossary series.

Updated October 2025 • FDA / GMP • Pharmaceutical Manufacturing

21 CFR Part 210 establishes the general cGMP framework for drug manufacturing, processing, packing, or holding. It defines the scope and definitions that underpin 21 CFR Part 211, which provides detailed operational requirements. Together, they ensure consistent product quality, safety, and identity across the pharmaceutical supply chain. This entry covers (1) What it is, (2) FAQs, and (3) How it relates to V5.

“Part 210 is the backbone of FDA’s drug GMP system—it defines who’s responsible, what qualifies as manufacturing, and how all operations must comply with Part 211.”

1) What It Is

Part 210 defines the current Good Manufacturing Practice (cGMP) for drugs as the minimum requirements for methods, facilities, and controls used in manufacturing, processing, packing, or holding. It applies to both human and veterinary drugs, whether prescription or over-the-counter, ensuring identity, strength, quality, and purity. It works in tandem with Part 211 (Finished Pharmaceuticals) and Part 11 (Electronic Records & Signatures).

Scope & application. Part 210 applies to all drug manufacturers subject to section 501(a)(2)(B) of the FD&C Act. It outlines which products are covered, defines what counts as manufacturing, and establishes that failure to comply renders a drug adulterated under U.S. law.

Key concepts introduced in Part 210:

• Definitions of scope. Clarifies what “drug,” “component,” “lot,” “control,” and “manufacture” mean within GMP context.
• Relationship to Part 211. Part 210 is the umbrella rule; Part 211 provides operational details for finished pharmaceuticals.
• Minimum standards for methods and facilities. Sets the expectation that methods and controls must ensure quality and purity for every drug lot.
• Adulteration definition. A drug is adulterated if manufactured in violation of cGMP regulations—legal basis for FDA enforcement.
• Responsibility for compliance. Manufacturers are responsible for meeting cGMP even when outsourcing activities to contract labs or packagers.
• Inspection and enforcement. Authorizes FDA inspection and documentation of GMP deficiencies under FD&C Act §704.

Authoritative references. Regulation text: 21 CFR Part 210 (eCFR). Also see 21 CFR Part 211 and Part 11 (Records & Signatures) for implementation context.

Where it shows up by industry. Applies to pharmaceutical manufacturing, combination products, and operations requiring validated processes, controlled facilities, and documentation of compliance.

2) FAQ

Q1. What is the difference between Part 210 and Part 211?
Part 210 defines the general principles and scope of GMP for drugs; Part 211 specifies detailed requirements for finished pharmaceutical manufacturing.

Q2. Who must comply with Part 210?
Any organization that manufactures, processes, packs, or holds a drug product intended for U.S. distribution must comply.

Q3. Does Part 210 apply to contract manufacturers?
Yes. Contract manufacturers and packagers performing regulated activities share cGMP responsibility with the product owner.

Q4. How does Part 210 interact with Part 11?
Part 11 defines how electronic records and signatures are managed for data required under Part 210/211. Validation and data integrity controls ensure records are trustworthy.

Q5. What is considered “adulterated” under Part 210?
Any drug made without adequate methods, controls, or facilities consistent with cGMP is legally adulterated and subject to enforcement.

Q6. Is there a difference between cGMP and GMP?
Yes. “cGMP” (“current” GMP) reflects ongoing expectations that manufacturers adopt modern technology and methods for process control and quality assurance.

Q7. Where can I read the full text?
See the official rule at eCFR 21 CFR Part 210 and related FDA guidances.

3) How It Relates to V5

V5 by SG Systems Global supports Part 210 and 211 compliance by digitally enforcing process controls, traceability, and record retention throughout manufacturing operations.

• Validated process execution. MES captures steps, materials, and sign-offs aligned to cGMP and Part 211 requirements.
• Quality management integration. QMS links deviations, CAPAs, and change control to production records and regulatory evidence.
• Electronic records and signatures. Part 11-aligned controls ensure identity, integrity, and traceability of records.
• Batch traceability and CoA. eBR and CoA generation pull data from verified sources to simplify review and release.
• ERP integration. Connect to NetSuite, Dynamics 365, Sage X3, and QuickBooks Desktop via V5 Connect API.

End-to-end example. A pharma manufacturer executes a validated process in V5 MES; deviations route to QMS for investigation; records are signed electronically under Part 11. QC reviews the data, generates a CoA, and archives records for FDA inspection.

Primary References:
• FDA eCFR: 21 CFR Part 210
• Related Rule: 21 CFR Part 211
• Electronic Records: 21 CFR Part 11