Direct Links to important GMP Biologic Guidelines

FDA Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Lot Release Protocols

Submitting lot release protocols in electronic format to CBER’s Product Release Branch

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FDA Guidance for Industry: Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications

The purpose of this guidance is to provide information to applicants on how FDA intends to use alternative tools to assess manufacturing facilities identified in a marketing application (i.e., a new drug application (NDA), an abbreviated new drug application (ANDA), a biologics license application (BLA), or a supplement to any of these types of applications)

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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.

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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.

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WHO Good Manufacturing Practices for biological products

GMP for the manufacture of biological products

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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)

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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.

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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

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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.

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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).

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