It causes a big confusion to understanding the occurrence of incidence and deviation in pharmaceuticals. A huge number of pharmaceutical professionals get difficulties to differentiate the incidence and deviation when they occur in real.
When we have any written procedure like standard operating procedure, protocol, standard test procedure, BMR etc. and someone works against this, then it is called deviation. It means deviation from any written procedure that we have implemented.
Now deviation can be of two different types:
A) Planned Deviation B) Unplanned Deviation
Planned deviations are those deviations from the procedure that are planned and we know before they occur. For example calibration or validation is not carried out as per schedule due to delay for various reasons. In this case, we have to fill CAPA for the same.
In the case of unplanned deviation, the failure of the procedure, utility, material, equipment or any system occurs. We can consider it as any change from the previous or our written procedure. Unplanned deviations may be critical, major or minor. These can be categorized on their impact on product quality.
Critical deviations: Manufacturing instructions are not followed, wrong batch details are printed, SOPs or methods of testing not followed during analysis etc.
Major deviations: Line clearance is not taken from QA, physician sample wrongly printed with price, etc.
Minor deviations: Raw material is received in a damaged container, manometer readings in the sampling booth are crossed the action limits etc.
An incidence is an event that can affect our product quality or not but that is against the cGMP. For example, someone is found without gowning in the production area or any insect is found in granulation area. These may have the impact on product quality but not every time, sometimes it will not impact. These are the deviations from GMP but the difference is that these are not related to our manufacturing process. So these will not be categorized as deviations.
Some other examples of incidence: eating food in the production area, spillage of material on the floor, break down in any machine during processing, the mix-up of two batches, wrong material added in batch etc.
Note: You can write your views on this topic in the comment box.
example of incident: wrong material added in batch etc. it is incidence but it is include in deviation.because it due to the follow wrong procedure.so:::
ReplyDeleteBut sir,there is not mentioned to add any other materials ,so you did the mistake which is against cGMP .So it will come under incidence.
DeleteHi Concern,
ReplyDeleteWhat you gave definition for deviation is perfectly matching. But in case of unplanned deviation as per industrial standard there is no unpalnned deviation. If any failures like procedural gaps, Human errors,Instrumental errors are will be addressed through Incident only.
if we know in advance that we will be deviating from the approved procedure, this will be manage through temporary / permanent change request through change control system.
ReplyDeleteIf we make a conscious decision to deviate the approved procedure during the process to save time, cost, resource etc... it will be a deviation.
Spillage of material, machine breakdown, fluctuation in the utility, malfunction of device etc... will be reported categorize under incidence
I have given a clear cut difference between deviation and incidence.
ReplyDeleteDeviation is any change from written procedure and incidence is a unwritten event that is against GMP.
I think it is clear now.
Thank you Sir for sharing such a fruitful information.
DeleteBut can you share any reference for using "Incidence/Event" terminology as both the terms are being handled through unplanned deviation.
Another example of Incidence/Event that we faced: Earthquake during routine working of firm.
Yes I agree on whatever the difference you gave between deviation and incidence but you gave the example of incidence is "some one is found without gowning in production area" wherever for gowning every company has a written procedure and as per definition of deviation, this example should fall under deviation.
DeleteYou are right
DeleteAs per cGMP, the only term referred in the guidelines was "Deviations" whether it may be Planned or Unplanned.
ReplyDeleteMr. Ankur is 100% correct. In case of Planned Deviation, CAPA is not important, rather change control is a must. However, there could be any number or nature of incidents that may or may not require CAPA depending upon the impact due the incident. Can natural calamity like flood, tremor etc. be recorded as incidents?
ReplyDeleteIncident X deviations
ReplyDeleteLab incident is the Event which may or may not cause deviation(s).
Incident is an unexpected/unplanned happening of an event which does not have direct impact on the product or production activity.
Incident and deviation are different because incident is unknowingly & deviation is knowingly . both are may be Quality impacting or not
Mr. Bhagvat is correct:
ReplyDeleteAny unexpected / unplanned event is called as incident. Incidents may also deviate the written instructions but if the incident is known than it should be handled through incident document and if incident is not known than it shall be handled through deviations
Incident- unexpected thing when following procedure.
ReplyDeleteDeviation - deviating procedure to get expected thing.
Incident is beyond our control like flood, earth quake, ceiling crack, leakage from facility floor etc..... Deviation is deviating the written procedure. Some company is raising Incident for Batch contamination!!! that's absolutely wrong!! May be SOP is not adequately laid down or wrong understanding by usre.
ReplyDeleteas you have given the example that if some is found without over gowning this is incident. But if there is SOP for gowning /de-gowning and some one found without over gowning. This will considers as deviation not incident
ReplyDeleteNaveen
Deviation is against the approved system, documents, parameters, GMP etc.. The Unplanned deviation is also can treat as incident.
ReplyDeleteIncident is an accidental work.. like spillage, after shifting the sieve found damage condition, at the time of compression the punch damaged etc...
i can't understand about incidence. can you describe me briefly this differenence between deviation and incidence????
ReplyDeleteDeviation is against the standard procedure which includes system, documents , process and also we can conclude that the unplanned deviation is like incident means both are vice versa
ReplyDeletePlease I would like to know any regulation what can mention the definition of incidents and deviations.
ReplyDeletedear ankur sir,
ReplyDeletethis blog is very uswful to me.if any incident happening at the time of process but the incident not affected on product quality but affect on equipment .so if any deviation requird for this case?
@ namenaeswar it is not required to fill the deviation for this case. Equipment breakdown form is required to fill for the same.
ReplyDeleteIf i am wrong, please correct me, Incidents are those which are out of human control and simply Deviation are the any departure from the written procedures or policies.
ReplyDeleteHi guys,
ReplyDeleteIts going well deviations vs incidents, now perception should be clear as given by Mr. Ankur & explained by various participants. But what about non-conformances, deviations & incidents that has to be made clear.Its a best platform to discuss.
As said manufacturing instructions are not followed under critical deviation, and wrong material addition in the batch under incident. can you brief about wrong material addition. (For example Material A to be added in the vessel first and B to be added after that. But in this case if B is added first and A added later.. will it come under incident or deviation.)
ReplyDeleteAs stated by you, Mr.Rajesh Reddy gaaru,manufacturing INSTRUCTIONS are NOT FOLLOWED. As per the SOP, there is a set procedure which you have violated, hence you must take up a Deviation...It is a clear cut case of Unplanned Deviation, as you have added B first and then A, instead of A first and then B next. It can also be recorded as an incident, but grossly it comes under UnPlanned deviation, it can be critical, if the material B were to behave defferently than being added with A first.Also, since it is not a deviation that was planned, also, a complete different procedure than SOP, you must take a change control and an Unplanned Deviation only
DeleteAs we know the simple deference between deviation and Incident , that is deviation categorized as departure from the approved instructions which are approved written procedures or GMP or regulatory systems. The incident simply called as the act or an event happens unexpectedly or unfortunately and ignorance, lack of training of the people.
ReplyDeleteDear ankur sir..
ReplyDeleteYou provided a best platform to discuss in pharmaceuticals..
Thank you sir.
You can discuss on Pharmaguideline forum at ask.pharmaguideline.com
DeleteNow d doubt got clear
ReplyDeleteThanks to all..
Rajesh Redyy@@ if this happen by mistake means human error, could be included as incident but if do this intently , no doubt its deviation
ReplyDeleteDear Sir you defined the both in a very general manner, I think the incidences are those sort of activities which held accidentally & could not be recoverable just like the spillage of RM on floor. But in case of eating in production area should not be categories as incident because it is a process which not held accidentally but intentionally & also be recoverable.
ReplyDeletekindly give your opinion.
Is it necessary to have planned deviation. cant we have temporary change instead.
ReplyDeleteTemporary change control and planned deviation are same.
Deletethanks to ankur sir and all participated candidates to clarify all confusions..
ReplyDeleteIf one controlled copy of SOP is not found after distribution in a particular area. Also if it is happened in next version of distribution. is it deviation or incident?
ReplyDeleteDuring test request generation time, wrong test request generat Or spelling mistakes. Than. It will part of incident or not
ReplyDeleteIf spelling mistakes during test generation time,is it incident?
ReplyDeleteIt will be deviation from the procedure- GDP. If there is no SOP for GDP then it will be treated as incident.
ReplyDeletesuppose while creating a new user in application and accidentally other user's name modified so what it should be deviation or incident ?
ReplyDeleteLoog book version was charged but we have write old version so we raised deviation
ReplyDeleteLog book case is deviation if written procedure in place
DeleteOtherwise incident
Is broken addition funnel while tranfering things from one reactor to another is a Deviation and the event happened outside the reactor.
ReplyDelete