Direkt Links to important GMP Biologic Guidelines

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).

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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.

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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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FDA Guidance for Industry: Analytical Procedures and Methods Validation for Drugs and Biologics

It provides recommendations on how you, the applicant, can submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products.

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FDA Guidance for Industry: Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products

This draft guidance provides the pharmaceutical industry with the Center for Drug Evaluation and Research’s (CDER’s) and the Center for Biologics Evaluation and Research’s (CBER’s) current thinking on allowable excess volume and labeled vial fill size in injectable drug and biological products.

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FDA Guidance for Industry: Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product

This guidance is intended to assist sponsors with the design and use of clinical pharmacology studies to support a decision that a proposed therapeutic biological product is biosimilar to its reference product

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FDA Guidance for Industry: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products

FDA is issuing this guidance document to describe the technical and scientific information that FDA expects in a marketing application for a pen, jet, or related injector device that is intended to be used with a drug or biological product

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FDA Guidance for Industry: Established Conditions: Rportable CMC Changes for Approved Drug and Biologic Products

This guidance has been developed to address the lack of clarity with respect to what chemistry, manufacturing, and controls (CMC) information in a marketing application constitutes an established condition or a “regulatory commitment” that, if changed following approval, requires reporting to FDA

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FDA Guidance for Industry: Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application

This guidance sets forth FDA’s policy regarding the mixing, diluting, and repackaging of certain types of biological products that have been licensed under section 351 of the Public Health Service Act (PHS Act) when such activities are not within the scope of the product’s approved biologics license application (BLA) as described in the approved labeling for the product.

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FDA Guidance for Industry: Environmental Assessment: Questions and answers regarding drugs with estrogenic, androgenic, or thyroid activity

This guidance is intended to supplement FDA’s guidance for industry on Environmental Assessment of Human Drug and Biologics Applications, issued July 1998 (the EA Guidance), by addressing specific considerations for drugs that have potential estrogenic, androgenic, or thyroid hormone pathway activity (E, A, or T activity) in environmental organisms.

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GMP Conferences by Topics

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