Certificate of Good Manufacturing Practices for Animal Drugs (CPOHB)

UMKU Details

Parameter:

All

Authority:

Minister/Head of Agency

Requirements:

  1. Approval of the Good Manufacturing Practice for Veterinary Drugs (CPOHB) Assessor

    2. Duration: -

  2. Document guides/manuals, procedures, work instructions, and quality forms

    3. Duration: -

  3. General Requirements: Letter of application to the Director General of Livestock and Animal Health

    4. Duration: -

  4. Hold a Veterinary Drug Manufacturing Business License

    5. Duration: -

  5. Have a master design for veterinary drug manufacturing and a list of veterinary drugs to be produced

    6. Duration: -

  6. Factory building layout equipped with air handling systems, water treatment, and waste management systems compliant with the Good Manufacturing Practice for Veterinary Drugs

    7. Duration: -

  7. 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

    8. Duration: -

  8. 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

    9. Duration: -

  9. Good Manufacturing Practice for Veterinary Drugs (CPOHB) includes:

    10. Manufacturing veterinary drugs (biological, pharmaceutical, and premix)

    Manufacturing Animal Cosmetics

    Manufacturing Traditional Veterinary Drugs

    Duration: -

Sector: Agriculture
Status: Available
Belongs to:
20233
21013
21014
21023
21024

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