We are a manufacturer of OTC Drugs that has undergone FDA inspections. We are considering using in-house stability data to set the expiration date of products. Currently, we are referring to outsourced stability data from an external lab(ISO 17025) for checking product stability and active potency. To ensure the acceptability of our in-house data, is it necessary to have an ISO 17025 certificate?
We are complying with CGMP.
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ISO 17025 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
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ISO 17025 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 17025 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
In all cases, the standard and regulatory body requirements needs must be met. In the case of CGMP as I understand the testing laboratory must be ISO 17025 accredited for the tests being performed. Your company needs to ensure that the laboratory results being used are valid, i.e. fit for your purpose. This includes reports that meet ISO 17025 accreditation requirements. All records must be retained as per your management system processes.
I suggest you reach out to the FDA and establish exactly what is required for stability studies.
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Jan 16, 2024