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FDA Guidance for Industry: Analytical Procedures and Methods Validation
FDA Guidance for Industry: Assay Development for Immunogenicity Testing of Therapeutic Proteins
FDA Guidance for Industry: Bioanalytical Method Validation
FDA Guidance for Industry: Residual Solvents in Drug Products Marketed in the United States
FDA Guidance for Industry: Reviewer Guidance, Validation of Chromatographic Methods
European Medicines Agency: ICH Topic Q 3 C (R3) Impurities: Residual Solvents
FDA Guidance for Industry: Validation of Cleaning Processes (7/93)
European Compliance Academy: Justification of Limits for Cleaning Validation in the Manufacture of Active Pharmaceutical Ingredients-Discussion of ICH Guideline Q7A
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ICH Q1A(R2) Stability Testing of New Drug Substances and Products
ICH Q1B Stability Testing : Photostability Testing of New Drug Substances and Products
ICH Q1C Stability Testing for New Dosage Forms
ICH Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
ICH Q2(R1) Validation of Analytical Procedures: Text and Methodology
ICH Q3A(R2) Impurities in New Drug Substances (Revised Guidelines)
ICH Q3C(R4) Impurities: Guideline for Residual Solvents
Q3B(R2): Impurities in New Drug Products (Revised Guideline)
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FDA Guidance for Industry: Investigating Out-of-Specification Test Results
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