Document ID: chunk:federal_register_of_legislation:F2014L00859:body:0:p3
Version: federal_register_of_legislation:F2014L00859
Segment Type: other
Provision Reference: 
Character Range: 5974–9154

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 environment.
9 Equipment
 (1) Equipment used in the manufacture of veterinary chemical products must be suitable for its intended purpose and appropriately operated, maintained and cleaned.  Equipment must be correctly installed and operated in accordance with written instructions that are appropriate for the equipment.
 (2) The design and layout of equipment must be such that:
          (a)   the risk of manufacturing error is minimised; and
          (b)   effective cleaning and maintenance are possible, in order to avoid cross-contamination of either intermediate materials or the finished product, the build-up of dust or dirt and, in general, to avoid any adverse environmental effect on the quality of the product.
10 Documentation
  Manufacturers of veterinary chemical products must establish and maintain a system of documentation, document control and record keeping that:
          (a)   provides precise specifications for starting materials, intermediate materials and finished products, manufacturing formulae and instructions, and operating procedures for associated manufacturing and quality control activities;
          (b)   provides a complete history of each item, batch, or quantity manufactured in a specified timeframe, of veterinary chemical product manufactured at the premises; and
          (c)   establishes a traceable connection between raw materials and the finished product.
11 Computer systems
 (1) Where, in any step in the manufacture of a veterinary chemical product, a computer is used for any activity that may affect the quality, safety or efficacy of the product, then the computer system must be subject to the principles of quality system management to ensure operational suitability.
 (2) The introduction of computer systems into any manufacturing process, including materials control, processing control, quality control and product distribution, must not adversely affect product quality or quality assurance processes.
12 Production
 (1) Veterinary chemical products must be manufactured to specifications in accordance with manufacturing information supplied as part of their application for a relevant approval, and as part of any subsequent variation of the particulars or conditions of such an approval.
 (2) Production operations must follow documented procedures that have been clearly defined by the manufacturer.
 (3) Any critical manufacturing process and any change to that manufacturing process, must be validated and formally approved by the holder of the licence or a person authorised by the holder for that purpose.  Where a change in the manufacturing process affects 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