Process Qualification - What is the recommended Sample Size for PQ?

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V

Vincnet

#3
Re: Does anyone have a template for Validation Master Plan to share?

oooooops,

I posted the above link without checking what was said in the document. So could a forum Moderator check that i did not post somethng that shouldn't have been posted.

Many thanks

V
 

mdurivage

Quite Involved in Discussions
#4
Re: Process Qualification

A process qualification (PQ) generaly requires 3 lots. The sample size for acceptance sampling should be based upon the risk and quality level.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#5
Re: Does anyone have a template for Validation Master Plan to share?

oooooops,

I posted the above link without checking what was said in the document. So could a forum Moderator check that i did not post somethng that shouldn't have been posted. <snip>
It's being discussed but the moderators. We'll remove the link it we decide its problematic. We don't yet know whether the blog it is posted on has the rights to the document to post it.
 

somashekar

Staff member
Super Moderator
#6
What is the recommended sample size for PQ?
You have to take a very rational call about this size based on your process. Please see here the intent of the PQ per the GHTF guidance, which will help you to decide your size.
In this phase the key objective is to demonstrate the process will consistently produce acceptable product under normal operating conditions.

PQ considerations include:
• Actual product and process parameters and procedures established in OQ
• Acceptability of the product
• Assurance of process capability as established in OQ
• Process repeatability, long term process stability

Challenges to the process should simulate conditions that will be encountered during actual manufacturing. Challenges should include the range of conditions as defined by the various action levels allowed in written standard operating procedures as established in the OQ phase. The challenges should be repeated enough times to assure that the results are meaningful and consistent.

Process and product data should be analyzed to determine what the normal range of variation is for the process output. Knowing the normal variation of the output is crucial in determining whether a process is operating in a state of control and is capable of consistently producing the specified output.

One of the outputs of OQ and PQ is the development of attributes for continuous monitoring and maintenance. Process and product data should also be analyzed to identify any variation due to controllable causes. Depending on the nature of the process and its sensitivity, controllable causes of variation may include:
• Temperature
• Humidity
• Variations in electrical supply
• Vibration
• Environmental contaminants
• Purity of process water
• Light
• Human factors (training, ergonomic factors, stress, etc.)
• Variability of materials
• Wear and tear of equipment

Appropriate measures should be taken to eliminate controllable causes of variation. Eliminating controllable causes of variation will reduce variation in the process output and result in a higher degree of assurance that the output will consistently meet specifications.
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#7
3 lots is the accepted norm. we use the standard sampling plans for routine production as our sample sizes for each lot and test type.
 

somashekar

Staff member
Super Moderator
#8
3 lots is the accepted norm. we use the standard sampling plans for routine production as our sample sizes for each lot and test type.
May I ask if the 3 lot is your accepted norm or a standard accepted norm based on some statistical study. A lot or lot size may be too vague to determine size for the performance qualification, more so if they are small lot sizes. In my case here, a tray quantity is a lot and in a day several lots are processed in the line. My PQ records come from several days production.
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#9
In the US, 3 lots (as a minimum) is taught as the general 'rule of thumb'. Certainly each industry, company and product / process will have its own unique characteristics to be considered. And certainly your regulatory agent may have different and more specific advice or requirements...

but that brings up the very good point: for the OP to get a usable answer more specifics are required about his exact situation. To simply ask 'what is the sample size for PQ' is a very vague question...and since Process Validation is not a fully developed and firm regulation with crustal clear requirements for the FDA, let alone other industries that utilize the IQ, OQ, PQ concept for process validation, there are few firm answers and even fewer correct answers that can be given.
 
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