Direct Links to important GMP Biologic Guidelines

Eudralex Volume 3 ICH Guideline Q11 on Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)

This guideline describes approaches to developing process and drug substance understanding and also provides guidance on what information should be provided in CTD sections 3.2.S.2.2 - 3.2.S.2.6. It provides further clarification on the principles and concepts described in ICH guidelines on Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality Systems (Q10) as they pertain to the development and manufacture of drug substance.

ICH Q11 Guideline: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) Questions and Answers

This document provides clarification to improve harmonisation of the considerations for the selection and justification of starting materials for API syntheses.

FDA Guidance for Industry: Format and Content of a REMS Document

This guidance provides updated recommendations for the format and content of a risk evaluation and mitigation strategy (REMS) document for a prescription drug product, including a biological drug product

Concept Paper on the development of a Guideline on the 4 quality aspects of mRNA vaccines

The published document from the European Medicines Agency addresses the need to establish a guideline on the quality aspects of mRNA vaccines. In recent years, the number of applications for clinical trials for human medicinal products as well as for marketing authorization for mRNA-containing medicinal products has increased significantly and is expected to continue to increase in the near future. From an analytical and regulatory perspective, mRNA vaccines are of interest because their classification depends on the target and/or whether they are derived by chemical or biological means. mRNA vaccines against infectious diseases must comply with the current guidelines for human vaccines. However, this new technology is not fully addressed in the existing documents. It is therefore proposed that a guideline be developed to address the specific aspects of the manufacturing process, characterization, specifications, and analytical control, as well as the definition of the active ingredient and finished product

FDA Draft Guidance for Industry: Considerations for the Design and Conduct of Externally Controlled 1 Trials for Drug and Biological Products1

This FDA guidance describes recommendations for sponsors and monitors of clinical trials to demonstrate the effectiveness and safety of a drug. An externally controlled trial is a type of clinical trial that compares the results of participants receiving an investigational treatment with the results of a comparison group that did not receive the same treatment. This comparison group may be drawn from previous treated or untreated subjects (historical control) or from treated or untreated subjects from the same time period but from a different setting (concurrent control). The guide addresses considerations for the design and analysis of external controlled trials and discusses potential biases that may lead to invalid study results. It will focus primarily on the use of patient data from other clinical trials or real-world data sources such as registries, electronic health records, and medical billing. The guidance also addresses considerations for communicating with FDA and ensuring FDA access to data fr

FDA Guidance for Industry: Bioanalytical Method Validation

This guidance helps sponsors of investigational new drug applications (INDs) or applicants of new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologic license applications (BLAs), and supplements validate bioanalytical methods used in human clinical pharmacology, bioavailability (BA), and bioequivalence (BE) studies that require pharmacokinetic, toxicokinetic, or biomarker concentration evaluation

FDA Guidance for Industry: Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments

This guidance applies to orally administered drug products and provides recommendations to sponsors who will use or recommend use of liquids and/or soft foods as vehicles for drug administration in investigational new drug applications (INDs), new drug applications (NDAs), Biologics License Applications (BLAs), as applicable, and in supplements to these applications.

FDA Guidance for Industry: Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA 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 biosimilar or interchangeable biological products regulated by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).

Content of the dossier for chemical purity and microbiological quality

Eudralex Volume 3 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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