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Guidance Documents

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General Documents

Guidance for Industry - Contract Manufacturing Arrangements for Drugs: Quality Agreements
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General Documents

Process Validation General Principles and Practices - Life Cycle Approach to Validation
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Recombinant Proteins & Biologics

A-Mab- A Case Study in Risk Based Approach to Bio-process Development
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Recombinant Proteins & Biologics

Points to consider in the Characterization of cell lines used to produce biologicals
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Recombinant Proteins & Biologics

ICH Q10- Guidance for Industry Pharmaceutical Quality System

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Recombinant Proteins & Biologics

ICH Q9- Guidance for Industry Quality Risk Management
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Recombinant Proteins & Biologics

ICH Q8- Guidance for Industry on Pharmaceutical Development
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Recombinant Proteins & Biologics

ICH Q5D - Guideline for Derivation and Characterization of Cell Substrates
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Recombinant Proteins & Biologics

IND application
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Recombinant Proteins & Biologics

Content and Format of IND for Drugs and Well Characterized Biologics
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BioSimilars

Guidance for Industry - Scientific Considerations in Demonstrating Biosimilariy to a Reference Product
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BioSimilars

Guidance for Industry - Demonstrating Biosimiliarity to a Reference Protein Product
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Cell And Gene Therapy

Guidance for Industry - Potency tests for Cellular and Gene Therapy Products
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Cell And Gene Therapy

Application of current statutory authorities to human somatic cell therapy products
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Cell And Gene Therapy

Guidance for Human Somatic Cell Therapy and Gene Therapy
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Cell And Gene Therapy

Guidance for Industry- Minimally manipulated unrelated allogeneic placental umbilical cord blood for hematopoetic reconstitution
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Cell And Gene Therapy

Points to consider in collection, processing and testing of ex-vivo-activated mononuclear leukocytes
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Cell And Gene Therapy

Proposed approach to regulation of cellular and tissue based products
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Cell And Gene Therapy

A-VAX Application of Quality By Design to Vaccines - 2012
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