Direct Links to important GMP Biologic Guidelines

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: IND Meetings for Human Drugs and Biologics Chemistry, Manufacturing, and Controls Information (Issued 5/2001, Posted 6/4/2001)

IND Meetings for Human Drugs and Biologics Chemistry, Manufacturing, and Controls Information (Issued 5/2001, Posted 6/4/2001)

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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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Classification of Products as Drugs and Devices & Additional Product Classification Issues

While issues have arisen relating to whether a product should be classified as a drug, device, biological product, or combination product, most of these issues have related to whether a product should be classified as either a drug or a device.3 Accordingly, this guidance focuses particularly on cases in which a product4 may be classified as a drug or device.5 This guidance also addresses additional issues relating to product classification, including how to obtain classification determinations from FDA for medical products.

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FDA Guidance for Industry: Advanced Manufacturing Technologies Designation Program

This guidance provides recommendations to persons and organizations interested in participating in FDA’s Advanced Manufacturing Technologies Designation Program, which is intended to facilitate the development of drugs, including biological products, manufactured using an AMT that has been designated as such under the program (hereinafter designated AMT

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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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