Direct Links to important GMP Biologic Guidelines

FDA Guidance for Industry: Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted under a BLA, NDA, or ANDA

This guidance covers emergency-use injectors submitted under a biologics license application (BLA), new drug application (NDA), or abbreviated new drug application (ANDA)

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

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

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Microbiological Quality Considerations in Non-Sterile Drug Manufacturing

This guidance is intended to assist manufacturers in assuring the control of microbiological2 quality of their non-sterile drugs (NSDs).The recommendations herein apply to solid non18 sterile dosage forms, as well as semi-solid, and liquid non-sterile dosage forms (e.g., topicallyapplied creams, lotions and swabs, and oral solutions and suspensions).

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