Hi
Is it necessary to put “Date” while Signing in Batch production records. Does any guideline refers the same.
(Sign with date is necessary or not?)
Raveendra
[quote=bujjikanchi]Is it necessary to put “Date” while Signing in Batch production records. Does any guideline refers the same.
(Sign with date is necessary or not?)
Raveendra[/quote]
The date ties the signature to the event. Otherwise, someone could sign ahead of time, well after the event, etc. Of course, that doesn’t prevent someone from intentionally misrepresenting the approval; but the date supports the veracity of the signature.
Also the date should be written in a format that is unambiguous. Generally the month should either be written out in full or the first three letters should be used. Formats that represent the month with a number are unacceptable as they can be ambiguous.
Hi,
The requirement of sign with date in batch production records can be found in Schedule M published by CDSCO Government of India (Refer Batch Production Records section 21).
Regards
T. Nageshwar
The signature and date demonstrate the person who does the task and time the task has been conducted. This is one of the good manufacturing practices which we shall enforce and implement in our day-to-day activities pertaining to manufacturing of pharmaceutical and medical devices.