Hi
Can anyone please help: What is an acceptable time frame for testing of process validation samples?
Is 1 month to test blends (or at least sensitive tests like assays and related subs) and 3 months for finished product acceptable?
Is there any known requirements for how these type of samples should be treated?
Dear, I dont know what exactly you are trying to say, Why do you want to wait for 1 month and 3 months for PV samples. Process validation is a continous process and executed as per the approved protocols and all the necessary tests like assay, dissolution, blend uniformity, wieght variation etc etc, are done as soon as possible, there should be no delay otherwise how u will proceed for the next step all these tests should comply to the specifications as well.
[quote=apoman]Hi
Can anyone please help: What is an acceptable time frame for testing of process validation samples?
Is 1 month to test blends (or at least sensitive tests like assays and related subs) and 3 months for finished product acceptable?
Is there any known requirements for how these type of samples should be treated?[/quote]
Process validation should be initiated on first three batches preferably, and all the critical control points must be evaluated very carefuly and if any observation and deviation occur, must be noted and rectify and incorporated in documents. there is no need for 1st month for assay and Cu and three months for other tests, if your process is carefully validated then there is no need to take extra samples and testing after that.
Thanks
Hi, thanks for your responses, maybe I should explain it better, I work for a pharm. company with products requiring process validation (either brand new products or legacy products requiring completion of first three batches manufactured), we are taking our samples at each stage of the protocol but due to limited resources in the Lab. these samples are not able to be tested straight away, some have been stored for two to three months… as per my first question’s, are my proposed limits acceptable? Are there any known requirements out there? I havn’t found any as such.
Ideally I would like them tested ASAP but as mentioned resources in the Lab are limited…
Well it seems a management problem, You better caculate standard hours and man hours and ask the management to provide you the suffecient man power. Validation work should not be done in haphazard manner, all the activities should be covered in VMP and planned in VMS. Validation needs proper resources, commitment and planning it should be taken as a serious issue to the company. Otherwise at the end it would be wastage of time and money.