| 1 | List of components included in veterinary drugs and feed additives, their quantity. |
| 2 | Methods for monitoring quality indicators of veterinary drugs and feed additives from domestic manufacturers, relevant texts of articles of the international or state pharmacopoeia (TS, IS, SS, CS, AS). |
| 3 | Production information of veterinary medicinal products and feed additives for business entities from the countries of the Commonwealth of Independent States or their representatives (TS, IS, SS, CS, AS). |
| 4 | Methods of quality control in accordance with technical requirements, relevant texts of articles of the international or state pharmacopoeia, methods of validation of veterinary medicinal products and feed additives produced in countries outside the Commonwealth of Independent States. |
| 5 | Draft instructions for the use of veterinary drugs and feed additives. |
| 6 | Quality certificates or certificates of conformity for veterinary medicinal products and feed additives. |
| 7 | Production data of veterinary drugs and feed additives (technological instructions or regulations, manufacturing flow chart). |
| 8 | Results of tests on efficacy, safety and stability of veterinary drugs and feed additives. |
| 9 | Substantiated information on the effectiveness, immunogenicity, avirulence of veterinary biological drugs and microorganisms strains used in their production (viruses, bacteria, fungi, etc.). |
| 10 | Samples of veterinary medicinal products and feed additives in quantities sufficient for their technical testing specified in the documentation and their active ingredients (substances), test systems, diagnostic kits. |
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Technical specifications (TS) for veterinary products are comprehensive dossiers comprising analytical procedures, validated test methods, and numerical acceptance criteria (ranges, limits) that define the quality, safety, and efficacy of a drug substance or medicinal product. They ensure consistency, covering composition, physical/chemical properties, and stability.
Industry standards (IS) for veterinary products primarily focus on Good Manufacturing Practices (GMP), clinical trial quality (GCP), and safety regulations, with guidelines from VICH (International Cooperation on Harmonisation) serving as the global benchmark. Key compliance areas include manufacturing quality, safety, efficacy, and labeling requirements managed by organizations like the FDA, EMA, and pharmacopeias (USP).
State Standards (SS) for veterinary products regulate the safety, quality, and efficacy of medicines, vaccines, and diagnostic tools to ensure animal health and food safety. These standards are enforced through state registration, requiring laboratory testing and dossier assessments (e.g., in Uzbekistan or Kazakhstan). International standards are developed by WOAH (World Organisation for Animal Health) and USP (US Pharmacopeia).
A Company Standard (CS) for veterinary products is a mandatory internal technical document defining specifications, analytical methods, manufacturing processes, and stability requirements for quality control, often aligning with regulatory guidelines like EMA or local FDA standards. It serves as the primary document for compliance, ensuring that every batch meets quality requirements before market release.
Approved Standards (AS) for veterinary products ensure safety, efficacy, and quality, enforced through regulatory bodies like the European Medicines Agency (EMA) or FDA Green Book. Standards cover manufacturing (GMP), pharmaceutical quality (USP-NF), and labeling. Key international guidelines are coordinated via VICH to harmonize technical requirements.