Manufacturing Principles

Manufacturers of veterinary chemical products in Australia need to comply with the APVMA’s Manufacturing Principles, which includes complying with the GMP Code.

The Agricultural and Veterinary Chemicals (Manufacturing Principles) Determination 2014 defines the basic principles that manufacturers of veterinary chemical products must comply with to obtain and retain a manufacturing licence.

The Manufacturing Principles discuss:

  • compliance with Code of Good Manufacturing Practice
  • quality management
  • personnel and training
  • equipment
  • documentation
  • computer systems
  • production
  • quality control
  • contracting out steps in the manufacture of a veterinary chemical product
  • internal audits
  • complaints and product recalls
  • sterile products
  • immunobiologicals and other products of biological origin.

Manufacturers are responsible for ensuring they comply with the Manufacturing Principles. The APVMA monitors compliance and, when necessary, can undertake enforcement actions to help protect the health and safety of people, animals and the environment.

These Manufacturing Principles are comparable to other codes of GMP:

  • Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), Guide to good manufacturing practice for medicinal products (2009)
  • World Health Organization (WHO), ‘Quality assurance of pharmaceuticals: a compendium of guidelines and related materials’, vol. 2, Good manufacturing practices and inspection.

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