Direct Links to important GMP Biologic Guidelines

Eudralex Volume 3 ICH Q9 Quality risk management

This guideline provides principles and examples of tools of quality risk management that can be applied throughout the lifecycle of drug substances and drug (medicinal) products, biological and biotechnological products


FDA Guidance for Industry: Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and Answers

This guidance is intended to clarify Agency expectations regarding facility information that should be included in original new drug application(s) (NDA); abbreviated new drug application(s) (ANDA); original biologics license application(s) (BLA); amendments; supplements; chemistry, manufacturing, and controls (CMC) supplements; and resubmissions to these submission types.


FDA Guidance for Industry: Importation of Certain FDA-1 Approved Human Prescription Drugs, 2 Including Biological Products, under 3 Section 801(d)(1)(B) of the Federal 4 Food, Drug, and Cosmetic Act

This guidance describes recommended procedures to obtain an additional National Drug Code (NDC) for an FDA-approved prescription drug that is imported into the United States in compliance with section 801 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 106 U.S.C. 381)


FDA Guidance for Industry: New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products

FDA intends this guidance to assist developers of medical imaging devices and imaging drug/biological products (hereinafter more generally referred to as drugs or drug products) that provide image contrast enhancement in determining


FDA Guidance for Industry: Bridging for Drug-Device and Biologic-Device Combination Products

This guidance provides recommendations to industry and FDA staff on how to approach 19 bridging in new drug applications (NDAs) or biologics license applications (BLAs) for drug-20 device and biologic-device single entity or copackaged combination products including the 21 following


GMP Conferences by Topics

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