Identifying risks to safety: Non GMP agents
Introduction
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).
Resources
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1. AMS Report ‘Microbial Challenge Studies of Human Volunteers’
AMS Report 'Microbial Challenge Studies of Human Volunteers'
Good Practice for em studies specifically Date added: 29 October 2008 -
2. EMA: Advanced Therapy Medicinal Products
Developing guidance available from EMA
Legal Requirement for some em studies (not applicable for all) Date added: 18 November 2008
