Direkt Links to important GMP Biologic Guidelines

ICH Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process

The objective of this document is to provide principles for assessing the comparability of biotechnological/biological products before and after changes are made in the manufacturing process for the drug substance or drug product.

FDA Inspections of Licensed Biological Thearpeutic Drug products

This program covers both specified and non-specified therapeutic biological drug products now regulated by CDER, but formerly regulated by CBER under this same program.

WHO Good Manufacturing Practices for biological products

GMP for the manufacture of biological products

FDA Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products Center for Biologics Evaluation and Research (CBER) Center for Drug Evaluation and Research (CDER) APRIL 1996

Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products Center for Biologics Evaluation and Research (CBER)

FDA Guidance for Industry: Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts

Standardized grass pollen extracts must demonstrate their potency in accordance with 21 CFR 680.3(e), 610.10, and 600.3(s). Accordingly, manufacturers must demonstrate that their grass pollen extracts maintain potency and are stable until the product's expiration date. The Center for Biologics Evaluation and Research (CBER) is setting forth this document to provide guidance on developing stability protocols for standardized grass pollen extracts.

Reflection paper on a proposed solution for dealing with minor deviations from the detail described in the Marketing Authorisation for Human and Veterinary Medicinal products (including biological products)

In this statement the EMEA emphasizes the responsibilities of the Qualified Person with respect to batch certification and release and the obligation of the manufacturer to keep the supervisory authority and the competent authority issuing the relevant marketing authorisation informed about non conforming batches.

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: Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process

his guideline is to provide principles for assessing the comparability of biotechnological/biological products before and after changes are made in the manufacturing process for the drug substance or drug product.

FDA Guidance for Industry: New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2)

This draft 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).

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

Page 3 of 13