Animal & Veterinary
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Chemistry Manufacturing and Controls (CMC)
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Chemistry Manufacturing and Controls (CMC)
CVM GFI #5 Stability Guidelines (PDF - 385KB)CVM GFI #23 Medicated Free Choice Feeds--Manufacturing Control CVM GFI #42 Animal Drug Manufacturing Guidelines- Series of Four Guidelines Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products (PDF - 57KB)CVM GFI #50 Target Animal and Human Food Safety,Drug Efficacy, Environmental and Manufacturing Studies for Teat Antiseptic Products CVM GFI #57 Preparation and Submission of Veterinary Master Files (PDF - 51KB)VICH GL1 - Validation of Analytical Procedures: Definition and Terminology (PDF - 65KB)VICH GL2 - Validation of Analytical Procedures: Methodology: Final Guidance (PDF - 168KB)VICH GL3(R) - Stability Testing Of New Veterinary Drug Substances (PDF - 228KB)VICH GL4 - Stability Testing of New Veterinary Dosage Forms (PDF - 65KB)VICH GL5 -Stability Testing-Photostability Testing of New Veterinary Drug Substances and Medicinal Products (PDF - 76KB)CVM GFI #83 Chemistry, Manufacturing and Controls Changes to Approved NADA/ANADA (PDF - 162KB)VICH GL8 - Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products on Stability Testing for Medicated Premixes (PDF - 33KB)VICH GL10(R) - Impurities In New Veterinary Drug Substances (PDF - 176KB)VICH GL11(R) - Impurities in New Veterinary Medicinal Products (PDF - 196KB)VICH GL17 - Testing of New Biotechnological/Biological Products (PDF - 82KB)VICH GL18 Residual Solvents in New Veterinary Medicinal Products (PDF - 164KB)CVM GFI #126 BACPAC I-Intermediates in Drug Substance Synthesis Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation (PDF - 134KB)CVM GFI #135 Validation of Analytical Procedures for Type C Medicated Feeds (PDF - 107KB)CVM GFI #136 Method Transfer Studies for Type C Medicated Feed Assay Methods (PDF - 105KB)CVM GFI #137 Analytical Methods Description for Type C Medicated Feeds (PDF - 94KB)CVM GFI #156 Comparability Protocols-Chemistry, Manufacturing, and Controls Information (PDF - 240KB)Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information (PDF - 82KB)CVM GFI #169 Drug Substance: Chemistry, Manufacturing, and Controls Information (PDF - 363KB)Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing (PDF - 123KB)PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (PDF - 315KB)Bioanalytical Method Validation (PDF - 63KB)CVM GFI #211 Residual Solvents Q&A (PDF - 79KB)CVM GFI #216 - CMC Fermentation-Derived Intermediates, Drug Substances, and Related Drug Products for Veterinary Medicinal Use (PDF - 78KB)Process Validation: General Principles and Practices (PDF - 292KB)CVM GFI #204 Active Controls in Studies to Demonstrate Effectiveness of a NAD for use in Companion Animals (PDF - 188KB)
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