Planned deviation

GOOD DOCUMENTATION PRACTICE (GDocP)
1

Hi,

If there is any error in protocol or new BMR, it is justify to take plan deviation.
Shall we do not revised the document and processed further instead to go for planned deviation.

2

Deviations are two typles

i.e Planned Deviations & unplanned deviations.

All planned deviations are permenant or temporaty.

All the planned deviations shall be followed by through change control it should be reviewed by all respective related departments and finally approved by QA dept.

Regards,

Rambabu
Kamud Drugs
09373082156

3

[quote=rudra]Hi,

If there is any error in protocol or new BMR, it is justify to take plan deviation.
Shall we do not revised the document and processed further instead to go for planned deviation.[/quote]

In my point of view, it is better if you revised the document eliminating the error. if document is not revised, planned deviation (change control) must be fiiled and approved for the changes made.