Direct Links to important GMP Biologic Guidelines

Eudralex Volume 3 ICH Topic Q4B Annex 4 C Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter

This annex is the result of the Q4B process for Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use.

FDA Guidance for Industry: Submitting Marketing Applications According to the ICH-CTD Format — General Considerations

This guidance document is intended to describe how to organize new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biological license applications (BLAs) based on the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines on the CTD.

FDA Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics - Questions and Answers

This document provides questions and answers relating to the guidance on Container Closure Systems for Packaging Human Drugs and Biologics (the guidance).

FDA Guidance for Industry: Questions and Answers on Biosimilar Development and the BPCI Act

This guidance document provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

Eudralex Volume 3 GUIDELINE ON ALLERGEN PRODUCTS: PRODUCTION AND QUALITY ISSUES

This document provides principles and guidance for the manufacturing and quality control of allergen products of biological origin, including allergen extracts from natural origin and allergens produced through recombinant DNA technology, used for specific immunotherapy (SIT) or in vivo diagnosis of immunoglobulin E (IgE) mediated allergic diseases.

Eudralex Volume 3 CONCEPT PAPER ON THE NEED TO REVISE THE GUIDELINE ON THE USE OF TRANSGENIC ANIMALS IN THE MANUFACTURE OF BIOLOGICAL MEDICINAL PRODUCTS FOR HUMAN USE (3AB7A OF JULY 1995)

This document is concerned with the use of transgenic animals to produce biological pharmaceutical materials for use in human recipients. Transgenic animals may produce higher quantities of material in more concentrated form than existing culture methods, and therefore have considerable advantages in both the cost of producing the starting material and in its downstream processing.

Eudralex Volume 3 Requirements for quality documentation concerning biological investigational medicinal products in clinical trials

This guideline outlines the requirements for the data to be presented on the biological, chemical and pharmaceutical quality of Investigational Medicinal Products (IMP) containing biological / biotechnology derived substances.

Eudralex Volume 3 Guideline on Real Time Release Testing (formerly Guideline on Parametric Release)

This guideline addresses the requirements for application of RTRT to different kinds of products e.g. chemical and biological products and its scope is to facilitate the introduction of RTR testing. The guideline is a revision of the guideline on parametric release and does not introduce new requirements.

Eudralex Volume 3 ICH Guideline Q11 on Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)

This guideline describes approaches to developing process and drug substance understanding and also provides guidance on what information should be provided in CTD sections 3.2.S.2.2 - 3.2.S.2.6. It provides further clarification on the principles and concepts described in ICH guidelines on Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality Systems (Q10) as they pertain to the development and manufacture of drug substance.

FDA Compliance Program Guidance Manual Chapter 42 – Blood and Blood Products Inspection of Source Plasma Establishments, Brokers, Testing Laboratories, and Contractors - 7342.002

This Compliance Program covers Source Plasma, Source Leukocytes, and Therapeutic Exchange Plasma intended for further manufacture into injectable drug products (e.g. immune globulin, albumin) and noninjectable products (e.g. in-vitro devices such as blood bank reagents), which are biological products subject to the licensure provisions of Section 351 of the Public Health Service Act (PHS).

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