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 Question:
100% sampling for all the containers - any document which supports, and how far it is implemented? Question Id:3027
K sunanda devi
06-14-2008 05:06AM
User Id: 98940
For 100%sampling of all the containers is difficult , We need justification to sample containers based on Critical/Non critical material . For critical all the containers will be sampled and for non critical square root n+1.

Is criticality based on the impact of RM on the process and final product or any other parameter if so what ?

 User Answer
SRK
04-18-2009 03:04AM
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As per cGMP & GLP the API must be sampled 100% and testing can be reduced by applaying braketing matrix approach ex: perform all container idetification test rest of parameter can use this approach, whereras the excipients can be used the approach of n+1 formula.
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