21 CFR Parts 600–680 – Biological Products & Vaccines

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

Updated October 2025 • FDA / CBER • Biological Products & Vaccines

21 CFR Parts 600–680 define FDA cGMP and testing requirements for biological products—including vaccines, blood, allergenics, and cellular or gene therapy materials. These regulations are administered by the FDA’s Center for Biologics Evaluation and Research (CBER) and establish rules for licensing, manufacturing, testing, labeling, and postmarket control to ensure product safety, purity, and potency.

“Parts 600 through 680 translate the same GMP principles from drugs and devices into the language of living systems — sterility, identity, purity, and stability.”

1) What It Is

These parts form a specialized extension of drug GMPs (Parts 210/211) for biological materials derived from human or animal sources. They govern facilities, personnel, sterility, testing, labeling, and reporting for all licensed biologics.

Scope & application. Applies to manufacturers, packagers, and testing labs handling vaccines, blood components, allergenics, or gene/cell therapies. Most products require a Biologics License Application (BLA) under Part 601 before marketing in the U.S.

Selected parts within 600–680:

• Part 600 – Biological Products: General. Definitions, reporting of adverse experiences, retention of samples, and contamination control.
• Part 601 – Licensing. BLA requirements, labeling, and postapproval changes.
• Part 606 – Blood and Blood Components. Donor qualification, collection, processing, labeling, and storage standards.
• Part 610 – General Biological Product Standards. Identity, purity, potency, and sterility testing requirements.
• Part 640 – Blood & Blood Components: Specific Requirements. For plasma, platelets, red cells, cryoprecipitate, etc.
• Part 660–680 – Specific Products (Serums, Toxoids, Allergenics). Product-specific test and stability requirements.

Electronic record controls. When biologics data or testing records are electronic, Part 11 applies — requiring validation, audit trails, secure signatures, and data retention policies.

Relation to other rules. These parts intersect with 210/211 (drugs), 820 (devices), 58 (GLP), and 4 (combination products).

2) FAQ

Q1. Do biologics follow drug or device GMPs?
Biologics follow specialized GMPs under 600–680, but the principles mirror drug GMP in Parts 210/211 and may incorporate device design controls if applicable.

Q2. What makes biologic manufacturing unique?
Living cells and biological materials introduce variability—requiring tight control of culture conditions, in-process testing, and validated aseptic methods.

Q3. What is a BLA?
A Biologics License Application under Part 601 is the regulatory authorization to market a biological product after demonstrating safety, purity, and potency.

Q4. Do clinical trial materials follow 600–680?
Investigational biologics follow GMP-like controls consistent with 600–680 expectations even before licensure.

Q5. How does Part 11 fit with biologics data?
Any electronic testing data, batch records, or CoAs fall under Part 11 for validation and audit trail integrity.

Q6. Where can I read the full text?
See the eCFR for 21 CFR Parts 600–680.

3) How It Relates to V5

V5 by SG Systems Global supports biologics and vaccine manufacturers by digitizing GMP controls, sample tracking, and validation documentation for compliance with Parts 600–680 and Part 11.

• Batch & lot traceability. eBMR links materials, tests, and results to the final lot release.
• Environmental & stability monitoring. Integrates data from instruments to support sterility and stability requirements under Part 610.
• Sample management & LIMS. LIMS Scheduling and CoA generation ensure controlled test records for identity, purity, and potency.
• Electronic records & signatures. Part 11-compliant audit trails and e-signatures for every batch and test.
• Deviation & CAPA tracking. QMS manages investigations and corrective actions linked to specific lots or equipment.
• ERP integration. Through V5 Connect API, biologics data flows to ERP systems (NetSuite, Dynamics 365, Sage X3).

End-to-end example. A vaccine manufacturer executes a validated eBMR; QC tests are scheduled in LIMS and audit-trailed; results generate a CoA and stability record per Part 610; deviations route to CAPA within QMS; all data maintain Part 11 integrity for FDA inspection.

Primary References:
• FDA eCFR: 21 CFR Parts 600–680
• FDA CBER Overview: Center for Biologics Evaluation and Research (CBER)
• Electronic Records: 21 CFR Part 11