Document ID: chunk:federal_register_of_legislation:F2014L00859:body:0:p2
Version: federal_register_of_legislation:F2014L00859
Segment Type: other
Provision Reference: 
Character Range: 3031–6261

the Code of Good Manufacturing Practice.
6 Quality management
 (1) Manufacturers of veterinary chemical products must have in place a quality assurance system to ensure that finished products are fit for their intended use, are manufactured in accordance with the manufacturing information mentioned in subsection 12(1) of this Determination, and do not place treated animals or users at risk due to inadequate quality, safety or efficacy.
 (2) The quality assurance system must ensure that:
          (a)   appropriate procedures are in place to ensure that the required quality standards – meaning the quality standards on which the relevant approvals of a chemical product are based – are met;
          (b)   all materials involved in the manufacturing process comply with required quality standards before they are released for use in manufacture;
          (c)   there are measures designed to prevent cross-contamination;
          (d)   there are safeguards and controls in place designed to prevent the occurrence of foreseeable errors or process failures; and
          (e)   finished products have been made and stored correctly, and comply with required quality standards before they are released for supply.
 (3) The quality assurance system must be relevant to the nature and intended use of the product.  It must be fully documented, monitored for effectiveness and provide for continuous improvement.
7 Personnel and training
 (1) Veterinary chemical products must be manufactured under the management and supervision of appropriately qualified, trained or experienced persons who:
          (a)   understand the specialised technical, quality and legal requirements relating to the manufacture of veterinary chemical products for which they have responsibility; and
          (b)   have their duties and responsibilities clearly defined by the manufacturer.
 (2) Manufacturing staff must be trained to a satisfactory level of competency in:
          (a)   the basic principles of good manufacturing practice; and
          (b)   the specific duties, in connection with the manufacture of veterinary chemical products, that they are required to perform.
 (3) There must be a sufficient number of competent personnel to carry out all required tasks.
8 Buildings and grounds
 (1) Veterinary chemical products must be manufactured in buildings that are located, designed, constructed, maintained and utilised to:
          (a)   suit the operations carried out in them;
          (b)   ensure protection of the veterinary chemical products from contamination;
          (c)   permit effective cleaning and maintenance, including cleaning after processes have been completed; and
          (d)   minimise the risk of manufacturing error.
 (2) The products must also be manufactured in an environment, or in equipment fitted with precautionary measures, that:
          (a)   ensures a standard of hygiene appropriate to the class of veterinary chemical product being manufactured;
          (b)   minimises the risk of cross-contamination of the finished product, or of materials or components that are used or manufactured at the premises; and
          (c)   ensures the safety of operators and protects the outside