:DAccording to regulatory guidelines how long company need to preserve the deviation & Change control.
Regards
Anup Sharma
I would think the duration of the documents that are assocaited with the change control or deviation.
[quote=anup_s82]:DAccording to regulatory guidelines how long company need to preserve the deviation & Change control.
Regards
Anup Sharma[/quote]
It means the duration is based on the type of change control & deviation. we decide it by one by one.
If, by regulatory, you mean US FDA, then I would argue that these are records that fall under the QSR and would thus be subject to 820.108(b). This defines record retention as “…a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution…”
Dear Anup
in my point of view, it depends on the fate of batch in which deviation/change control filled and retention period allocated by the company.
what is deviation and how many types it is,how to handle the deviation with one case study
Deviation is defined as any departure from an approved instruction or established standard. It requires evaluating, investigation, response and control.
Following are types of deviations:
Deviations from all departments
OOS From labs
OOT (Raw materials, Components, Containers & Closures, API, Finished products)
It is implemented by CAPA approach.Normally a closed loop approach.
•Identification of problem
•Evaluation and data gathering
•Analysis investigation
•RCA (Root cause analysis)
•Development of action plan
•Implementation of CA
•Follow-up
•Verification of effectiveness
•Implementation of PA
Hi,
Deviation may be categorized under head like…Planned & Un-planned.
Planned : Intended, Pre-panned, well assessed, planned departure from standard
un-planned : Un-intended, assessment after occurance
There is a difference in OOS & Deviation.
While we are talking about change control & deviation preservation period…absolutely till the life cycle of impact system / product (Perpatual or product life time). Logic ; Base document to assess history.
Happy Reading !