Direkt Links to important GMP Biologic Guidelines

FDA Guidance for Industry: Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products (Issued 7/1997, Posted 7/28/1997)

Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products

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

Container Closure Systems for Packaging Human Drugs and Biologics

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FDA Guidance for Industry: Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products

This guideline forms an annex to the main ICH Stability Guideline (Q1A) and deals with the particular aspects of stability test procedures needed to take account of the special characteristics of products, in which the active components are typically proteins and/or polypeptides.

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FDA Guidance for Industry: Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products; Availability

This guideline provides broad guidance on appropriate standards for the derivation of human and animal cell lines and microbes used to prepare biotechnological/biological products and for the preparation and characterisation of cell banks to be used for production.

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FDA Guidance for Industry: Q6B Specifications: Test-Procedures and Acceptance Criteria for Biotechnological/Biological Products

This guidance document provides guidance on general principles for the setting and justification of a uniform set of international specifications for biotechnological and biological products.

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ICH Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products

This guideline forms an annex to the main ICH Stability Guideline (Q1A) and deals with the particular aspects of stability test procedures needed to take account of the special characteristics of products, in which the active components are typically proteins and/or polypeptides.

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ICH Q5D Derivation and Characterisation of Cell Substrates Used For Production of Biotechnological/Biological Products

This guideline provides broad guidance on appropriate standards for the derivation of human and animal cell lines and microbes used to prepare biotechnological/biological products and for the preparation and characterisation of cell banks to be used for production.

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Reflection Paper: Chemical, pharmaceutical and biological information to be included in dossiers when Process Analytical Technology (PAT) is employed

This reflection paper has been published by the EMEA PAT team to provide preliminary recommendations on how PAT related information should be presented in applications or variations to Marketing Authorisations.

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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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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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GMP Conferences by Topics

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