Does anyone have ideas about quality warning letters that are given to production operators from quality assurance team in production due to not following SOPs or doing any deviations against GMP and GDP
Thanks in advance
Yes it would happen, if the issue is considered as data integrity related.
Basically from QA point point of view in production shop floor any deviations against GMP and GDP should reported through observation book with categorization whether it was Major,minor or critical.
And there must be a written procedure for the individual plant that how to handle the categorized observation like if it was critical then the concern with investigation team must evaluate the deviation and according to CAPA if it was found as negligence of that particular operator then he/she must be issued Quality letter as per management rules.
What is quality letter?
It’s basically Quality warning letter. Some organization called it as observation book and if the observation found that it is deviating the Quality policy of that particular plant then he/she may got the the warning letter from the management authority…
Thanks sabinesh sir