[b]Follow These steps for Planned Deviation:
[COLOR=“blue”]Any Deviation in the procedure, process, equipment, standard or batch size which is planned, documented, assessed for its impact on product quality and authorized in advance, with the agreement of all concerned shall be known as planned deviation.
All planned deviations shall be recorded in an annexure.
Maintain a logbook for the approved planned deviations.
The concerned department executive / manager shall initiate the “Planned Deviation Process” by documenting the following and signing off:
Deviation related to (procedure, process, equipment, standard, batch size etc.)
Justification / Rationale
The department head and plant head shall review the proposal for planned deviation, justification given and compliance to regulatory requirements, for necessity / feasibility of the same and sign off in the specified column.
QA shall assign a unique number to each planned deviation.
Head QA shall review the planned deviation with respect to impact on product quality, necessity / feasibility of the deviation proposed, rationale / justification & compliance to cGMP / regulatory requirements, along with the adequacy of the supporting data attached and approve or reject the deviation.
If approved, the deviation shall last for a defined number of batches or number of days.
Date od closing or stoppage of such Planned Deviations must be recorded too.[/b][/color]