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Dear Guys,
I am pulling my hair out right now (the little that I have) trying to figure out how to do packaging validation for our product. We deliver our products non-sterilized, so I dont really thing that ISO 11607 is the most appropriate and it seems quite burdensome. I have checked the GHTF 's final document Quality Management Systems-Process validation Guidance, but am still at a lost.
I guess my biggest problem is IQ OQ and PQ, and how they integrate into validating a process vs. a single machine. We have conducted ISO 2247 and 8318, but I dont know if that is sufficient.
Please Help!!!!
I am pulling my hair out right now (the little that I have) trying to figure out how to do packaging validation for our product. We deliver our products non-sterilized, so I dont really thing that ISO 11607 is the most appropriate and it seems quite burdensome. I have checked the GHTF 's final document Quality Management Systems-Process validation Guidance, but am still at a lost.

I guess my biggest problem is IQ OQ and PQ, and how they integrate into validating a process vs. a single machine. We have conducted ISO 2247 and 8318, but I dont know if that is sufficient.
Please Help!!!!

