Risk Assessment - Chemical


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Can anyone advise as to how I would go about carrying a risk assessment, if I want to change from one supplier to another for a Saline solution.

Not sure what what I should be looking for or what such a risk assessment should look like,

Thank you

Bev D

Heretical Statistician
Super Moderator
Here is my response from your post. On our sister site:
What is the saline solution used for? There are many uses, some of which might require a change validation (intravenous use or eye drops) and some that might not. The basic ‘problem’ to look for is contamination and perhaps salt concentration.
Is this an off-the-shelf part that would certify conformance to certain specifications or is it a custom order?


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The basic ‘problem’ to look for is contamination and perhaps salt concentration.
This is out of my area of expertise, but would it be prudent to breakdown contamination into chemical contamination and biological (non-sterile) contamination? Thinking of the recent issues with non-sterile eye drops.


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further to the queries from @Bev D @Miner
it sounds like, alternate vendor, or change management for change in supplier for the saline solution.

if its part of the product, then it requires full blown bridging studies covering relevant aspects related to the in-use / solution stability, shelf life, including Q1/Q2 etc.,
if its part of the manufacturing process, for cleaning / rinsing purposes.,
then, it is only appropriate to establish or monitor the cleaning validation, analytical method validations etc.,
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