Hi,
Is legacy analytical method validation / methods needs to be verified? Is there any guideline recommending for this requirement?
Could you please elaborate the meaning of below statement given in WHO Annex-4 draft guideline about method validation.
“2.6 The procedure should become part of a continuous verification procedure to demonstrate that it meets the predefined criteria over the life of the procedure”
In short, you have to demonstrate through documentation that the analytical method is compliant with current guidances (that it is part of a lifecycle monitoring program). For instance a legacy GC method could have been used for an industrial product but is then transferred to a pharmaceutical which means it now has to comply with ICH Q2, USP <621>…
Dear Boomer,
A method is developed, validated and is being used regularly for pharmaceutical product. If any changes to method will route through change control system and requirement of validation will be assessed. Still it needs to be verified periodically.
If yes, What needs to verified during periodic verification?
Periodic verification depends on your SOP. It can be 2 years which is common. System suitability as per USP <621> is used to demonstrate that the chromatograph is suitable. In addition, for verification, I would include, linearity (with LOQ), accuracy, and precision of the sample.
Hi,
The method is using regularly i.e. daily number of batches are analysed with same method.
Then why SST and other parameters verification is required on periodic basis?
I can also agree if any method is not used frequently, then method verification is required.
SST is required for every lot/sample as per USP <621>. Periodic verification is not required by any regulation that I know but is a good practice in lifecycle management. It should be written in your SOP.
See this from Waters (the HPLC people). Talk about timely!
https://view6.workcast.net/register?cpak=5778546013279170&sf98584143=1