Document ID: chunk:federal_register_of_legislation:F2014L00859:body:0:p5
Version: federal_register_of_legislation:F2014L00859
Segment Type: other
Provision Reference: 
Character Range: 11647–14051

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 quality.
 (2) Manufacturers must also have in place a documented and effective procedure for recalling from the marketplace product that is known to be defective, or is suspected of being defective.
17 Sterile products
 (1) Veterinary chemical products that are required to be, or are represented as being, sterile, must be manufactured:
          (a)   in separate, controlled areas in the premises that have:
 (i) high standards of hygiene; and
 (ii) a system of controlling particulate contaminants that is appropriate to the class of veterinary chemical product being manufactured;
          (b)   with special care and attention to detail; and
          (c)   in accordance with procedures established and validated by the manufacturer.
 (2) The manufacturer must establish procedures and have equipment available (or in the case of bioburden, have access to equipment) to adequately monitor:
          (a)   the microbiological status of the environment in production areas; and
          (b)   the microbial load of the veterinary chemical products that are to be sterilised.
18 Immunobiologicals and other products of biological origin
  Veterinary immunobiological products and other chemical products of biological origin, including those that are manufactured using a specified biological process, must be manufactured:
          (a)   using biological starting materials that are, or are derived from, biological materials demonstrated to be as free as practicable from adventitious contamination;
          (b)   in premises designed, constructed and maintained so as to provide an appropriate level of containment of the biological or microbiological agents being handled and to permit effective decontamination from these agents or from toxic residues by procedures that:
 (i) are established and validated by the manufacturer; and
 (ii) maintain the safety of personnel; and
          (c)   in cases where uniformity of product depends on deriving batches from a seed lot:
 (i) by maintaining the lots in secure and protective storage; and
 (ii) by keeping detailed and comprehensive records of their origin and disposition.