Document ID: chunk:federal_register_of_legislation:F2014L00859:body:0:p4
Version: federal_register_of_legislation:F2014L00859
Segment Type: other
Provision Reference: 
Character Range: 8900–11910

the specifications of the product such that the product no longer complies with the particulars or conditions of a relevant approval, formal approval of such changes must be obtained from the relevant authority before the affected product is released for supply.
13 Quality control
 (1) Manufacturers of veterinary chemical products must have in place an effective quality control system that is designed to ensure that, before products are released from manufacture for supply, they meet the specifications for the product on which any relevant approval of the product is based, and have been manufactured in accordance with the manufacturer's documented procedures.
 (2) The person responsible for quality control must be sufficiently independent of other aspects of the manufacturing operation to allow effective implementation of the quality control function.

 (3) Manufacturers must ensure that analytical laboratories and animal testing facilities used in a step in the manufacture of a veterinary chemical product follow the principles of good laboratory practice.
14 Contracting out steps in the manufacture of a veterinary chemical product
 (1) Where a licensed manufacturer contracts all or some of the steps in the manufacture of a veterinary chemical product to another person, the licensed manufacturer must ensure that, before manufacture commences, it has entered into a signed written 'GMP Agreement' with the other person that clearly specifies each party's responsibility in relation to every aspect of the manufacturing process, assurance of product quality and consistency with the specifications for the product on which any relevant approval of the product is based.
 (2) Arrangements for contracting out steps in the manufacture of a veterinary chemical product must not compromise the quality of the product.
 (3) Where a person is permitted to carry out a step in the manufacture of a veterinary chemical product under the licence of another manufacturer (pursuant to regulation 59A of the Agvet Regulations), the licence holder must exert direct control over and maintain oversight of the quality management of the step.
15 Internal audits
  Manufacturers of veterinary chemical products must regularly and systematically carry out internal audits of all aspects of their manufacturing operations, as well as of their quality assurance system, in order to monitor compliance with their authorised procedures, standards and requirements and to ensure product quality.  Steps must be taken to assess the outcomes of the internal audits and to implement any necessary corrective and preventive action identified by those internal audits.
16 Complaints and product recalls
 (1) Manufacturers of veterinary chemical products must have in place a system of handling complaints regarding products they have manufactured on the licensed premises.  There must be a documented system of recording, investigating and, where appropriate, acting upon all complaints that may be related to product