Direct Links to important GMP Biologic Guidelines

FDA Guidance for Industry: Possible Dioxin/PCB Contamination of Drug and Biological Products

This guidance is intended for manufacturers using materials derived from animal sources in the manufacture of human or animal drugs or biological products

FDA Guidance for Industry:Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Core Guideline

This guideline applies to pharmaceutical drug substances (i.e., active pharmaceutical ingredients) and pharmaceutical drug products, including marketed chemical, and biotechnological/biological products.

FDA Guidance for Industry: Size of Beads in Drug Products Labeled for Sprinkle

This draft guidance provides sponsors of new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics licensing applications (BLAs) the Center for Drug Evaluation and Research’s current thinking on appropriate size ranges for beads2 in drug products that are labeled to be administered via sprinkling (e.g., capsules or packets containing beads).

Eudralex Volume 10 Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials

requirements for quality documentation concerning biological investigational medicinal products in clinical trials

FDA Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers

This guidance provides recommendations for biological product, drug, and device firms on FDA’s current thinking concerning the testing recommendations and acceptance criteria in the United States Pharmacopeia (USP) Chapter <85> Bacterial Endotoxins Test, USP Chapter <161> Transfusion and Infusion Assemblies and Similar Medical Devices,and the Association for the Advancement of Medical Instrumentation (AAMI) ST72:2002/R2010, Bacterial Endotoxins—Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing (AAMI ST72).

FDA Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product"

This document comprises information about analytical factors and the importance of extensive analytical, physico-chemical and biological characterisation of a Biosimilar. These factors are unalienable to demonstrate highly similarity to a reference product.

Eudralex Volume 3 EMA Procedural advice for users of the centralised procedure for similar biological medicinal products applications

The document includes basic questions like "What is a similar biological medicinal product?" as well as more complex questions like "If the patent situation differs in the various Member States how will this be reflected in the product information of my similar biological medicinal product?" Furthermore, the answers comprise direct links to the related regulations and guidelines.

FDA Guidance for Industry: Nuclear Pharmacy Guideline Criteria for Determining When to Register as a Drug Establishment

This guideline prepared by the FDA's Center for Drugs and Biologics states the criteria for determining when a nuclear pharmacy is required to register as a drug establishment.

FDA Guidance for Industry and FDA Staff - Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4

This guidance identifies additional, technical information that should be submitted by sponsors who seek to rely on conformity to ISO 11040-4 for a glass syringe product.

FDA Current 21 CFR Part 4 Good Manufacturing Practice Requirements for Combination Products

The Food and Drug Administration (FDA or Agency) is issuing this regulation on the current good manufacturing practice (CGMP)requirements applicable to combination products. This rule is intended to promote the public health by clarifying which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products.

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