Facility Changeover

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
1

Dear All,

I would like to know what all activities with respect to validation need to be done when a steroid manufacturing facilty is to be changed for manufacturing of oncology drugs.

Thanks in advance.

2

Your validation master plan needs to provide the guidance for what needs to be done.

Beyond that, start with expecting to do a full re-validation. Then look at risk and decide if anything can be excluded. Document your decisions and rationale. I would expect that, presuming you followed the standard IQ/OQ/PQ approach, full IQ, partial OQ, and full or partial PQ. Again, you have to justify (document) your approach and decisions.

3

[quote=yodon]Your validation master plan needs to provide the guidance for what needs to be done.

Beyond that, start with expecting to do a full re-validation. Then look at risk and decide if anything can be excluded. Document your decisions and rationale. I would expect that, presuming you followed the standard IQ/OQ/PQ approach, full IQ, partial OQ, and full or partial PQ. Again, you have to justify (document) your approach and decisions.[/quote]

Thanks.

Besides these, how to go for Cleaning Validation?What should be the acceptance criteria?

Best Regards.