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Identifying risks to safety: Non GMP agents

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For agents where it is not possible or practical to obtain and use a product manufactured to GMP, the following quality control issues should be considered, in light of the potential risks posed by the intervention:

  • Previous clinical experience of using the agent
  • Pharmacology
  • Toxicology
  • Facilities and likely consistency of manufacturing process
  • Purity and contaminant testing
  • Batch comparisons 
  • Handling and formulation requirements
  • Storage conditions, duration of storage and stability

The use of agents not manufactured to GMP or equivalent standards, must be monitored and managed accordingly if their use is to be justified (see: 'Minimising safety risks' on this Tool Kit).