Is it possible to omit micro sampling for a CV program if I can justify the omission by claiming:
- We can effectively reduce API/detergent residue to a determined limit
- Clean equipment does not sit for longer than 10 days
- Equipment is sanitized after cleaning and before use
- Purified water is used for final rinse
- Water is not allowed to pool in equipment (i.e.: equipment is completely dry)
- Micro testing will be captured during our quarterly environmental monitoring
This is for a solid dose company, no liquid, all oral, nothing sterile.
I don’t have a problem doing the micro sampling but it starts to look more an more unnecessary as I try to justify doing it.
Thanks for any input.