References: Annex 4 to the good manufacturing practices guide for veterinary drugs
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Laws and regulations
- Feeds Act
- Feeds Regulations, 1983
- Food and Drugs Act
- Food and Drug Regulations
- Health of Animals Act
- Health of Animals Regulations
Good manufacturing practices
- Good manufacturing practices guide for drug products (GUI-0001)
- Good manufacturing practices for active pharmaceutical ingredients (GUI-0104)
International guidance documents
- Manufacture of veterinary medicinal product other than immunologicals
- VICH GL2 Validation of analytical procedures: Methodology
- VICH GL3 Stability testing of new veterinary drug substances and medicinal products
- VICH GL8 Stability testing for medicated premixes
- VICH GL10 Impurities in new veterinary drug substances
- VICH GL11 Impurities in new veterinary medicinal products
- VICH GL18 Impurities: Residual solvents in new veterinary medicinal products, active substances and excipients
- VICH GL39 Test procedures and acceptance criteria for new veterinary drug substances and new medicinal products: Chemical substances + decision trees
- VICH GL40 Test procedures and acceptance criteria for new biotechnological/biological veterinary medicinal products
- VICH GL45 Bracketing and matrixing designs for stability testing of new veterinary drug substances and medicinal products
- VICH GL51 Statistical evaluation of stability data