In Batch record for some operation mention Done by sign and then check by sign.
So During Batch Record Review if you are find both done by and check by sign pending so how to handle that documentation?
For eg: in granulation during drying after every 10 minutes you have to record parameters in batch record and done by and check by sign to be done… operator mention the parameters but done by sign not done and supervisor check by sign also not done. Also machine print out is not available then how to handle that document?
Raise a deviation and go for CAPA and close after training to the person responsible for the same.
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Impart the training on good documentation pracrice
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Still there is a question that activity was happened or not bcz of absence of any supporting documents.
Activiy happened bcz physically work is performed.As for as documentaton is concerned raise deviation n Capa with Traning
In above example ,observed value was recorded by operator ,only sign is pending…