Hello All
I have a few questions as to what clause fits certain type of validation we are/want to perform, while I develop the SOP's.
1. For Process (IQ, OQ, PQ) and software, I believe clauses 4.16, and 7.5.6 are appropriate and have developed this SOP accordingly.
2. I'm struggling a bit on the next items:
- Product Conformance, would this be part of my design and development SOP?
- For laboratory and equipment cleaning, I am not sure where this should fit? Possibly process?
Any help would be appreciated.
Thanks
I have a few questions as to what clause fits certain type of validation we are/want to perform, while I develop the SOP's.
1. For Process (IQ, OQ, PQ) and software, I believe clauses 4.16, and 7.5.6 are appropriate and have developed this SOP accordingly.
2. I'm struggling a bit on the next items:
- Product Conformance, would this be part of my design and development SOP?
- For laboratory and equipment cleaning, I am not sure where this should fit? Possibly process?
Any help would be appreciated.
Thanks