dear all,
Can anybody tell me about the acceptance criteria for performance qualification (PQ), all i want to ask is "does the acceptance criteria in PQ always with statistical calculation such as RSD or doesnt always with RSD calculation or is there other acceptance criteria?"
im still confused
THANK
rika_ndry,
The acceptance criteria can be either variable in nature (e.g. torque specification achieved) or an attribute (e.g. item present).
Regards,
Kevin
What particular piece of equipment or process is this in relation to?
dear SV & morphius909,
this is about performance qualification of production equipment for pharmaceutical industries.
can you explain more about “The acceptance criteria can be either variable in nature (e.g. torque specification achieved) or an attribute (e.g. item present).” ?
thx
Hmm…
Well statistics is all great for the academic type, but not always warranted.
Let’s say…you want to validate a tank sterilization process…let’s say a media sterilization…so basically, we ask ourselves, what is the acceptance criteria for performing a sterilization on a media in a process tank?
Success = Sterile Media after whatever predefined days of incubation, following your sterilization process
Failure = contaminated media after whatever predefined days of incubation, following your sterilization process.
Do its 3x for us in Canada/US and 5x for Eur and voila PQ performed. You’ve proven, through 3x/5x consecutive sterile media samples that your PQ of that particular piece of equipment is successful.
This is over simplied but should get the point across.
Clear as mud?
[quote=rika_ndry]dear all,
Can anybody tell me about the acceptance criteria for performance qualification (PQ), all i want to ask is "does the acceptance criteria in PQ always with statistical calculation such as RSD or doesnt always with RSD calculation or is there other acceptance criteria?"
im still confused
THANK[/quote]
Reporting criteria for PQ is just not the %RSD, there is lot more about the acceptance criteria u need to know and it definitely depend physical and microbiological qualification aspects. Like capability study incase of PQ of a Compression Machine (physical aspect) and temperature distribution, heat penetration, and spore log reduction incase of moist heat sterilization processes (biological aspect).
Hi all. Just to add my thoughts and experience. The acceptance criteria will be altered, adapted and suited to the test in question. In my opinion, your ultimate goal is to test for the integration the 5M’s,
Management
Material
Man
Machine
Method.
Hope this is of some help.