Direct Links to important GMP Biologic Guidelines

Eudralex Volume 3 Guideline on Quality of biological active substances produced by transgene expression in animals

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Eudralex Volume 3 Guideline on the use of starting materials and intermediates collected from different sources in the manufacturing of non-recombinant biological medicinal products

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FDA Guidance for Industry: Safety Assessment for IND Safety Reporting

This document provides guidance to sponsors on developing a systematic approach for investigational new drug application (IND) safety reporting for human drugs and biological products developed under an IND.

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Guidance for Industry: Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products

This guidance provides recommendations to industry on formal meetings between the Food and Drug Administration (FDA) and sponsors or applicants relating to the development and review of drug or biological drug products (hereafter products) regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

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FDA Guidance for Industry: Safety Considerations for Product Design to Minimize Medication Errors

The recommendations in this guidance apply broadly to the development of drug and biologic products. Accordingly, this guidance is intended for sponsors of investigational new drug applications (INDs); applicants of new drug applications (NDAs), biologics licensing applications (BLAs), abbreviated new drug applications (ANDAs); and manufacturers of prescription drugs marketed without an approved application or over-the-counter (OTC) monograph drugs.

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FDA Guidance for Industry: Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information

This guidance provides recommendations to holders of applications for human drugs and biologics on implementing a chemistry, manufacturing, and controls (CMC) postapproval change through the use of a comparability protocol (CP).

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ICH E2F DEVELOPMENT SAFETY UPDATE REPORT

The main focus of the DSUR is data from interventional clinical trials (referred to in this document as "clinical trials") of investigational drugs including biologicals, with or without a marketing approval, whether conducted by commercial or non-commercial sponsors.

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Eudralex Volume 9 Product- or Population-Specific Considerations II: Biological medicinal products

Biological medicinal products

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FDA Guidance for Industry: Submission of Quality Metrics Data

This revised draft guidance includes an explanation of how the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) intend to utilize submitted data and quality metrics to help ensure that their policies and practices continue to support continuous improvement and innovation in the pharmaceutical manufacturing industry.

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FDA Guidance for Industry: CMC Postapproval Manufacturing Changes for Specific Biological Products To Be Documented in Annual Reports

This guidance provides recommendations to holders of biologics license applications (BLAs) for specified products regarding the types of changes to an approved BLA to be documented in an annual report under 21 CFR 601.12.

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GMP Conferences by Topics

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