You have limited seconds/moments for anything... in your life, for your audit preparation, working hours..... everything.
Now you have access to almost every piece of information in the world. But do you have time to go through everything? Do you have time to experience everything? Do you have time to do every mistake & then learn from it?
Noooooooooooooooo.
What I believe that it is more important to know what to say No than should be done. Having information/awareness of everything that is to be done is knowledge. But knowing what should not be done is wisdom.
And since more than 2.5 yrs we discuss some or the other points which we should avoid or we should not do.
Today again one similar observation which we discuss every couple of days I have brought to your notice. Which you also know.
Its an observation of Case # 634647 WL
1. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).
Your firm failed to conduct adequate and timely investigations relating to products made by both terminal sterilization and aseptic processing.
Your firm’s testing found cross-contamination of drugs in at least three lots of drug products. You failed to adequately identify the root cause or scope of potentially impacted lots in a timely manner....
Review the deviations, QMS, and Investigations.
Whether investigations are properly done?
Whether the actual root cause is determined?
Whether investigation study extended to impacted batches?
Write conclusion.
Make a plan of action.
Implement the decision.