Biosafety research on GMP
One of the central responsibilities of SG within biosafety research on GMP is to give scientific replies to safety-related questions regarding the interaction of GMP with target and non-target organisms and with the environment. Biosafety research
- enlarges the knowledge of safety-relevant contexts and thus contributes to further develop the knowledge basis for safety assessment and safety management;
- contributes to adapt safety assessment and safety management to the state of the art;
- aims to detect, and reduce, possible risks resulting from GMP.
The aim of publicly funded biosafety research is not to furnish a safety certificate which is legally required for the authorisation of commercial GMP products.
Biosafety research on GMP principally observes the rules of good scientific practice. In order to form a solid scientific basis for safety evaluations it must comply with the following requirements.
Requirements of biosafety research:
- Investigations into the interactions between GMP and the environment, especially their effects on target and non-target organisms
- Improvement, simplification, and adaptation of methods of safety research and assessment
- Further development and control of biological systems impeding an unwanted spread of certain GMP (confinement)
- Working out systems to produce GMP whose safety assessment is easier than before