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Code of Federal Regulations (CFRs)
BC4cGMP51
2024-04-01T17:42:33+00:00
Code of Federal Regulations (CFRs)
Biologics/Biotechnology
21 CFR 610
Guidance Documents
Biologics Guidances | FDA
Cellular & Gene Therapy Guidances | FDA
Biotechnology Guidance Documents & Regulatory Information | FDA
Blood Derivatives
21 CFR 606
Guidance Documents
Blood Guidances | FDA
Compound Pharmacies (503B)
21 CFR 210,
21 CFR 211
Guidance Documents
Interim Policy on Compounding – 503B
Human Drug Compounding | FDA
Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities | FDA
Cosmetics
FDA Cosmetic Regulations
Guidance Documents
Draft Guidance for Industry: Cosmetic Good Manufacturing Practices | FDA
Cosmetics Guidance Documents | FDA
Code of Federal Regulations Sections for Cosmetics Labeling (CFR Title 21, Part 701) | FDA
Dietary Supplements
21 CFR 111
Guidance Documents
Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements | FDA
Distribution
21 CFR 205
Guidance Documents
Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act | FDA
Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act–Compliance Policies | FDA
Drugs, General, API
21 CFR 210
Guidance Documents
Guidances | Drugs | FDA
Finished Pharmaceuticals
21 CFR 211
Guidance Documents
Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Guidance for Industry (fda.gov)
Q10 Pharmaceutical Quality System
Process Validation: General Principles and Practices (fda.gov)
Guidance for Industry (fda.gov)
Food for Humans
21 CFR 110,
21 CFR 117
Guidance Documents
Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food | FDA
Food for Animals
21 CFR 507
Guidance Documents
Guidance for Industry, Small Entity Compliance Guide #241 (fda.gov)
Gene Therapy
21 CFR 1271
Guidance Documents
Cellular & Gene Therapy Guidances | FDA
Medical Devices
21 CFR 807
Guidance Documents
Guidance Documents (Medical Devices and Radiation-Emitting Products) | FDA
Quality System Regulation
21 CFR 820
Guidance Documents
Q10 Pharmaceutical Quality System | FDA
Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations | FDA
Radiopharmaceuticals
21 CFR 212
Guidance Documents
Guidance for Industry (fda.gov)
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