Hi All:
Could someone please weigh in on this. Should a planned deviation be [B]approved[/b] prior to implementation or is pre-approval sufficient from cGMP stand point?
Thanks for clarification.
Hello,
You need to justify if the planned deviation can be avoided initially.
Is it a cost issue, timeline, pressure from a manager?
Then ask yourself what impact will this have on your process, how will this be resolved when the execution is complete.
If it can be avoided I would try and prevent this from happening, different companies have different cultures!
Chandra
Yes,
Planned deviation shall always be approved before execution of deviation.
The documentation (before approval) should include the parameters to be monitored during execution of deviation.
The quality of final output shall be checked & compared with regular process.
While closing the deviation, it should be evaluated for effectiveness, whether the purpose of taking deviation is acheived/not. If not, such deviation in future shall be avoided.
If the deviation is as per the expection the same can be considered for regularisation.
After briefing on all the above points deviation shall be closed.
Satish Dange.
[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:
Product Name
Batch Number
Market
Batch Size
Manufacturing Date
Expiry Date
Deviation related to (procedure, process, equipment, standard, batch size etc.)
Deviation details
Justification / Rationale
Supporting Data
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]