What is the planned deviation & whether we have to specified it in SOP of Deviation Procedure?
Deviations can be of two types;
Ex. - During compression of a batch, the compression m/c undergoes breakdown and the compression need to be done on another compression m/c.
Ex : one of the raw materialfor the batch is under testing and you need to start dispensing process for the batch, which is not a routine approved process.
One shall specify procedure for handling of both type of deviations in SOP. SOP shall clearly define, who all are responsible for review and approval of both types of deviation.
As far as I know, any deviation, it is unforeseen or foreseen, it is a deviation.
They shouldnt not be distinguished, since that kind of clasification can make you to take less responsability on the latter.
Any deviation, should be treated like one and adecuately investigated. You must use a batch of raw material without testing?, then make a document for the deviation and investigate why you had to do it and eliminate that problem.
You must always aplicate a CAPA system.
I would agree with AiC’s post and add that much care should be taken when handling planned events through a Deviation reporting system. Root Cause analysis and trending of planned Deviations may also be awkward, since it may be identified that known problems have not been dealt with. This does not look good in a managment review!
From a QA standpoint, I would recommend that planned activites go through your Change Control process where possible. For the most part, planned activities will allow adequate time to implement changes to equipment, documentation and systems prior to commencement of the activity. I would also point out that CAPA from planned Deviations may well include the same changes that could have been implemented prior to the activity.
Having said all this, planned Deviations may be unavoidable and changes to activities are far better recorded up-front. So in my opinion, your systems should allow for their use (occasionally and as a last resort). But I would not classify them separately, for the reasons given by AiC.
UnPlaned deviation requires the CAPA or not. in which cases
If the process is validated & other machine is like to like than batch could be processed on other machine.
If m/c is not like to like, & process is not validated, prior shifting on other m/c, process trial to be done for some qty & justification to be given that compression on other m/c can produce tablets according to predetermine specification. Any case, batch must be subjected for stability.
Can you please tell me something about Trackwise? How does it help in dealing with any deviation?
TRACKWISE is a deviation management software developed by sparta system. The following are briefly stated in their website.
TrackWise can be used as deviation management software that enables you to track and manage a broad range of deviations, from inception through investigation, root cause analysis, execution of corrective and preventive actions (CAPAs), and subsequent change controls.
TrackWise gives you a fully configurable automated deviation management solution that has the flexibility to fit the specific needs of your corporate processes while providing a rigorous controlled environment that mitigates risk and facilitates compliance and regulatory conformance.
Decrease cycle time and production/operation costs by increasing deviation management efficiency
Increase deviation management transparency through automated alerts and extensive reporting capabilities featuring dashboards and executive overviews
Increase accountability though assignments, process step approvals and audit trails
Reduce the risk of lost or incomplete data through a closed-loop deviation management process
Decrease the risk of repeating errors and issues by improving root cause analysis using built-in decision trees and drill-down selection lists
Facilitate compliance with pharmaceutical and biotech industry regulations including ISO 9001 and 14001; 21 CFR parts 11, 210 and 211; ISO/IEC 17025:2005 and other international standards
Integrate your deviation management system with other enterprise-level control systems such as enterprise resource planning (ERP) systems, manufacturing execution systems (MES), batch release systems and regulatory reporting systems
I hope this helps.