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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).


  • 1. AMS Report ‘Microbial Challenge Studies of Human Volunteers’

    An Academy for Medical Sciences (AMS) report that addresses the risks, benefits and conduct of microbial challenge studies of human volunteers, with particular emphasis on vaccine development. Although directed specifically at best practise in microbial challenge studies, most of the findings can be applied more generally to experimental medicine studies.

    Good Practice for em studies specifically Date added: 29 October 2008
  • 2. EMA: Advanced Therapy Medicinal Products

    European Medicines Agency (EMA) guidance on Advanced Therapy Medicinal Products (ATMPs) i.e. medicines for human use that are based on gene therapy, somatic-cell therapy or tissue engineering.

    Legal Requirement for some em studies (not applicable for all) Date added: 18 November 2008