Drug GMP Inspection Regulations


Drug GMP Inspections

The FDA’s drug cGMP inspections, including the quality control unit and all of its review and approval duties (e.g., change control, reprocessing, batch release, annual record review, validation protocols, and reports, etc.), all product defect evaluations and evaluation of returned and salvaged drug products, fall under 21 CFR 211 Subparts B, E, F, G, I, J, and K. Read More

Inspections of Compressed Medical Gas Manufacturers

All sections of 21 CFR Part 211 are applicable to the compressed medical gas industry unless specifically exempted from the regulations (e.g., per 21 CFR 211.196, lot or control numbers are not required on CMG distribution records). Read More

Drug Quality Reporting System (DQRS) (Medwatch Reports)

Districts must complete, in a timely manner, their investigations and follow-up to those DQRS (MedWatch) reports, furnished by the Drug Surveillance and Data Reporting Branch (DSDRB, formerly within the Division of Compliance Risk Management and Surveillance (DCRMS)) Read More

Inspections of Licensed Biological Therapeutic Drug Products

FDA is responsible for ensuring that biological products are safe and effective and in compliance with the law and FDA regulations. Biological products are licensed under the provisions of Section 351 of the Public Health Service Act (42 USC) (PHS Act). Read More

Positron Emission Tomography Drugs Inspections

The cGMP requirements for PET drugs differ in many significant ways from the cGMP requirements for non-PET drugs found in 21 CFR Parts 210 and 211. The requirements of 21 CFR 212 Current Good Manufacturing Practice (cGMP) for Positron Emission Tomography Drugs include differences concerning personnel; aseptic processing; quality control of components; self-verification of production steps; same-person oversight of production; batch record review; authorization of product release; and labeling requirements. Read More

Radioactive Drugs Inspections

With the exception of certain research uses of radioactive drugs (as specified in 21 CFR 361.1), all radiopharmaceuticals are considered to be new drugs and subject to the applicable provisions of the Food, Drug, and Cosmetic Act and the drug regulations issued under Title 21 of the Code of Federal Regulations. Read More

Drug Repackagers and Relabelers Inspections

The FDA inspects the operations of drug repackagers and relabelers as they relate to the provisions of the current good manufacturing practice (cGMP) regulations, 21 CFR 210 and 211, and to assess the compliance with all labeling requirements of the Food, Drug, and Cosmetic Act and its implementing regulations for repackaged drugs. Read More

Fraudulent Drug Inspections

Fraudulent drug inspections shall be conducted to counter two types of hazards: direct health hazard and indirect health hazard. Read More