Direct Links to important GMP Biologic Guidelines

FDA Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff

This guidance has been prepared by the Center for Devices and Radiological Health (CDRH), in coordination with the Center for Biologics Evaluation and Research (CBER), to assist medical device manufacturers in preparing and maintaining the QS information required in premarket submissions1. This guidance replaces “Guidance for Preparation

PIC/S Aide Memoire on INSPECTION OF BIOTECHNOLOGY MANUFACTURES (PI 024-3)

The aide memoires applies to biotech products and classical biological products for human use, but could also be used for gene-therapy and cell-therapy products. It includes also products for use in clinical trials. The aide memoires should be considered as a non-exhaustive list of areas to be looked at during an inspection.

FDA Guidance for Industry: BIOANALYTICAL METHOD VALIDATION

This guideline is intended to provide recommendations for the validation of bioanalytical assays for chemical and biological drug quantification and their application in the analysis of study samples

FDA Guidance for Industry: On the Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for an Allergenic Extract or Allergen Patch Test

This document provides guidance on the content and format of the Chemistry, Manufacturing, and Controls (CMC) section of a Biologics License Application for an Allergenic Extract or Allergen Patch Test.

FDA Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments

Recommendations for Reporting of BPD (Biological Product Deviation)

FDA Guidance for Industry: Bar Code Label Requirements, Questions and Answers

Question and answers to the topic of Bar Code Labeling of biological products

FDA Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products

We, FDA, are issuing this guidance to provide you, manufacturers of cellular and gene therapy (CGT) products, with recommendations for developing tests1 to measure potency.2 These recommendations are intended to clarify the potency information that could support an Investigational New Drug Application3 (IND) or a Biologics License Application4 (BLA).

FDA Guidance for Industry Monoclonal Antibodies Used as Reagents in Drug Manufacturing

This guidance is intended to provide recommendations to sponsors and applicants on the use of monoclonal antibodies(mAbs) as reagents in the manufacture of drug substances 2 that are regulated by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research(CBER). The guidance focuses on the chemistry, manufacturing, and control (CMC) issues that should be addressed in new drug applications(NDAs), abbreviated new drug applications (ANDAs), biologics license applications(BLAs), supplements to these applications, or investigational new drug applications (INDs).

FDA Guidance for Industry Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Biological In Vitro Diagnostic Product

This document is intended for use by those firms which manufacture any licensed in vitro diagnostics used to screen donor blood, determine donor suitability, test for retroviral infection, or determine transfusion compatibility.

FDA Guidance for Industry For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Plasma- Derived Biological Products, Animal Plasma or Serum-Derived Products

This document provides guidance on the content and format of the Chemistry, Manufacturing and Controls (CMC) section and the Establishment Description section of a Biologics License Application for a Human Plasma-Derived Biological Product, Animal Plasma or Serum-Derived Product.

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