Certificate of Good Manufacturing Practices for Animal Drugs (CPOHB)
UMKU Details
Parameter:
All
Authority:
Minister/Head of Agency
Requirements:
- Approval of the Good Manufacturing Practice for Veterinary Drugs (CPOHB) Assessor
- Document guides/manuals, procedures, work instructions, and quality forms
- General Requirements: Letter of application to the Director General of Livestock and Animal Health
- Hold a Veterinary Drug Manufacturing Business License
- Have a master design for veterinary drug manufacturing and a list of veterinary drugs to be produced
- Factory building layout equipped with air handling systems, water treatment, and waste management systems compliant with the Good Manufacturing Practice for Veterinary Drugs
- Master file for Good Manufacturing Practice for Veterinary Drugs (site master file/SMF) or equivalent quality guide/documentation detailing the complete veterinary drug manufacturing business process
- For recertification (reapplication), attach a list of significant changes since the last CPOHB inspection, and a letter of corrective action and preventive action (CAPA) results, and a list of storage since the last CPOHB inspection
- Good Manufacturing Practice for Veterinary Drugs (CPOHB) includes:
Duration: -
Duration: -
Duration: -
Duration: -
Duration: -
Duration: -
Duration: -
Duration: -
Manufacturing veterinary drugs (biological, pharmaceutical, and premix)
Manufacturing Animal Cosmetics
Manufacturing Traditional Veterinary Drugs
Duration: -
Sector: Agriculture
Status: Available
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