Hello! Everyone! Is there anyone who can tell me what are the quality control test needed for saline nasal spray? USP NF does not have a monograph for this. I hope there is someone who can help me. Thank you in advanced.
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I don’t know of any pharmacopeial standard refering that prouduct or its components, but perhaps this could be a useful advice:
You could base your control strategy using a Quality by Design (QbD) approach to determine the product’s Critical Quality Attributes (CQA). Quality control tests can then be established to verify compliance with these CQA’s.
Pharmacopeial tests are considered the minimum required quality to comply with, but QbD approach will enhance your product knowlende and process understanding to ensure the quality of the product.
I’d recommend reading ICH Pharmaceutical Development guideline (ICH Q8 guideline) which talks best about establishing Critical Quality Attributes:
Thank you very much!
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