Direct Links to important GMP Biologic Guidelines

FDA Guidance for Industry: Analytical Procedures and Methods Validation for Drugs and Biologics

It provides recommendations on how you, the applicant, can submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products.

FDA Guidance for Industry: Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products

This draft guidance provides the pharmaceutical industry with the Center for Drug Evaluation and Research’s (CDER’s) and the Center for Biologics Evaluation and Research’s (CBER’s) current thinking on allowable excess volume and labeled vial fill size in injectable drug and biological products.

FDA Guidance for Industry: Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product

This guidance is intended to assist sponsors with the design and use of clinical pharmacology studies to support a decision that a proposed therapeutic biological product is biosimilar to its reference product

FDA Guidance for Industry: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products

FDA is issuing this guidance document to describe the technical and scientific information that FDA expects in a marketing application for a pen, jet, or related injector device that is intended to be used with a drug or biological product

FDA Guidance for Industry: Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products

This guidance has been developed to address the lack of clarity with respect to what chemistry, manufacturing, and controls (CMC) information in a marketing application constitutes an established condition or a “regulatory commitment” that, if changed following approval, requires reporting to FDA

FDA Guidance for Industry: Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application

This guidance sets forth FDA’s policy regarding the mixing, diluting, and repackaging of certain types of biological products that have been licensed under section 351 of the Public Health Service Act (PHS Act) when such activities are not within the scope of the product’s approved biologics license application (BLA) as described in the approved labeling for the product.

FDA Guidance for Industry: Environmental Assessment: Questions and answers regarding drugs with estrogenic, androgenic, or thyroid activity

This guidance is intended to supplement FDA’s guidance for industry on Environmental Assessment of Human Drug and Biologics Applications, issued July 1998 (the EA Guidance), by addressing specific considerations for drugs that have potential estrogenic, androgenic, or thyroid hormone pathway activity (E, A, or T activity) in environmental organisms.

Eudralex Volume 3 Guideline on Quality of biological active substances produced by transgene expression in animals

Eudralex Volume 3 Guideline on the use of starting materials and intermediates collected from different sources in the manufacturing of non-recombinant biological medicinal products

FDA Guidance for Industry: Safety Assessment for IND Safety Reporting

This document provides guidance to sponsors on developing a systematic approach for investigational new drug application (IND) safety reporting for human drugs and biological products developed under an IND.

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