Dear All,
Due to the delays in the regulatory approval, our medical device (syringe) now have a manufacturing gap of 1 year. Last year we performed a full gamma validation (VDmax25) that included the dose mapping.
We manufacture other products at our clean room and regularly monitor environmental monitoring data and bio-burden determination of few products (they are not kind of products though).
Considering there are no major changes in the design and packaging can we conduct partial gamma validation? (as below)
? Bioburden determination on 10 samples
? Dose verification (10 sample with ref to table 9 ISO 11137-2)
? Sterility test (accept if no more than one positive test obtained)
? Prepare partial validation report (summarizing details)
Just want to know am I on right track or we need to perform a full validation along with dose mapping?
Thanks,
Nash
Due to the delays in the regulatory approval, our medical device (syringe) now have a manufacturing gap of 1 year. Last year we performed a full gamma validation (VDmax25) that included the dose mapping.
We manufacture other products at our clean room and regularly monitor environmental monitoring data and bio-burden determination of few products (they are not kind of products though).
Considering there are no major changes in the design and packaging can we conduct partial gamma validation? (as below)
? Bioburden determination on 10 samples
? Dose verification (10 sample with ref to table 9 ISO 11137-2)
? Sterility test (accept if no more than one positive test obtained)
? Prepare partial validation report (summarizing details)
Just want to know am I on right track or we need to perform a full validation along with dose mapping?
Thanks,
Nash