Frequently Asked Questions
2. How does a risk assessment assist when evaluating extractables and leachables?
Subjecting all of the materials used in a
pharmaceutical container closure system
pharmaceutical manufacturing process
to a full extractables study, and then using the subsequent data to develop and validate leachables methods capable of monitoring ALL potential leachables, at or below the AET, is a huge task, and takes large amounts of time, resource and budget to carry out.
It can be argued, with good scientific justification, that not all materials used are high risk with respect to generating leachables. At the very least, it can be argued again with good scientific justification, that they are not all high risk with respect to generating leachables that are harmful to patients/consumers.
As such, a process to filter out the lower risk materials, which have little or no potential for generating leachables, from the higher risk materials, which are very likely to generate leachables, and so should have the majority of time and effort spent on them, has the potential to save significant amounts of time, resource and budget, whilst providing much more relevant information on the identities and levels of leachables a patient/consumer is likely to be exposed to.
An extractables and leachables risk assessment is a tool that when performed in a robust manner, will act as this filtering process.
The outputs from the risk assessment will inform which materials are of high risk of generating leachables, and so need close attention and a greater level of time and resource spent on assessing them. Mitigation activities can then be carried out on these higher risk materials. This may involve some form of testing (extractables and/or leachables studies) or other forms of mitigation activity, in order to reduce the risk of patients/consumers being exposed to leachables.
The outputs from the risk assessment just as importantly provide a scientific justification for NOT testing materials that are of low risk of generating leachables. This means that resources are directed at the materials most at risk of generating leachables.
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