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Animal & Veterinary
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Chemistry Manufacturing and Controls (CMS)
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- CVM GFI #5 Stability Guidelines (PDF - 375KB)
- 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 - 279KB)
- VICH GL2 - Validation of Analytical Procedures: Methodology: Final Guidance (PDF - 47KB)
- VICH GL3(R) - Stability Testing Of New Veterinary Drug Substances (PDF - 224KB)
- VICH GL4 - Stability Testing of New Veterinary Dosage Forms (PDF - 8KB)
- VICH GL5 -Stability Testing-Photostability Testing of New Veterinary Drug Substances and Medicinal Products (PDF - 36KB)
- CVM GFI #83 Chemistry, Manufacturing and Controls Changes to Approved NADA/ANADA (PDF - 220KB)
- VICH GL8 - Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products on Stability Testing for Medicated Premixes (PDF - 14KB)
- VICH GL10(R) - Impurities In New Veterinary Drug Substances (PDF - 179KB)
- VICH GL11(R) - Impurities in New Veterinary Medicinal Products (PDF - 185KB)
- VICH GL17 - Testing of New Biotechnological/Biological Products (PDF - 41KB)
- VICH GL18 Residual Solvents in New Veterinary Medicinal Products (PDF - 57KB)
- CVM GFI #126 BACPAC I-Intermediates in Drug Substance Synthesis Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation (PDF - 259KB)
- CVM GFI #135 Validation of Analytical Procedures for Type C Medicated Feeds (PDF - 49KB)
- CVM GFI #136 Method Transfer Studies for Type C Medicated Feed Assay Methods (PDF - 127KB)
- CVM GFI #137 Analytical Methods Description for Type C Medicated Feeds (PDF - 112KB)
- 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 - 469KB)
- Providing Regulatory Submissions in Electronic Format – (PDF - 123KB)
- CVM GFI #196 Process Validation: General Principles and Practices (PDF - 131KB)
- PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (PDF - 315KB)
- Bioanalytical Method Validation (PDF - 63KB)
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