Hello all, I just want to ask question regarding who should be responsible for the pull-out of In-Process Samples and Fill Monitoring (deliverables) during the operation. Is it the Quality Assurance Inspector or the Production Personnel?
Ideally, in process samples should be withdrawn by IPQC / IPQC persons who are working on the shop floor and report to Quality unit head. This ensures unbiased sampling procedure followed by them. They are responsible for sampling and analysis of the samples in IPQC laboratory which is a separate unit located on the shop floor and is a part of QC / QA but independent of production.
However, it is also an industry practice to do sampling by production persons who draw the samples and submit to QC laboratory for analysis.
In both the cases this must be done according to written procedures (SOPs) and a well defined sampling plan.
Samples for q.c are collected by IPQC person.
Production person and IPQC take samples for BMR readings after specified intervals.
both have to enter readings.
What is different between IPQC & IPQA?
Inprocess quality control
inprocess quality assurance
role of ipqa in pharmaceutical industry