Deviation in Pharmaceutical Companies Part 1 of 2, in Hindi & English
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- Опубликовано: 12 сен 2024
- This video is about Deviation in Pharmaceutical Companies Part 1 of 2, in Hindi & English
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What is Deviation?
In Pharmaceutical companies, there are SOPs, Protocols, Standard test procedures, BMRs and Miscellaneous Instructions. Non-conformances and working against of these procedures and instructions called deviation.
Types of Deviation
1. Planned Deviation
2. Unplanned Deviation
1. Planned Deviation
Planned prior to the execution of an activity, which is to be undertaken following documented, justifiable and approved rationale.
Planned deviation” is frequently used to describe a decision to carry out a process in a different way from which it is established in a SOP, Method or Manufacturing Batch Record (e.g., a reprocess) due to an unforeseen event. Planned deviations need to be fully documented and justified. Usually, planned deviations associated to onetime events, , and change control to permanent changes.
For example: Calibration or validation is not carried out as per schedule due to delay for various reasons.
2. Unplanned Deviation
An accidental or unanticipated nonconformance or deviation observed or noticed during or after the execution of an activity. An unplanned deviation can be a critical or major or minor in nature.
For example: deviation in failure of procedure, utility, material, equipment or any system is occurred. We can consider it as any change from the previous or our written procedure.
While carrying out day to day activities, there is a probability of unplanned deviations (unforeseen deviations) occurring. Such unexpected events may be related to any procedures, processes, systems, equipment and utilities. These deviations may occur for many reasons, such as following (not all inclusive):
Equipment failure / Breakdown / Malfunctioning.
Power supply failure / interruption.
Accident in the plant.
Breakdown in support services / utilities.
Documentation Errors
Laboratory failure / Error.
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Currently there no concept like incident and deviation. The US and Europe companies use term event which is included all and there is no concept called unplanned deviation.
If you like to perform any change then its through change control and protocol.
Yes you are right sir, but there are number of companies also following the same concept
What if we want to intentionally deviate SOP with mitigating impact.
This will be under planned deviation is it so ?
Sir data integrity pai bhi video bnaiye
Okay
Kindly mention in your vedios frequency of closures of investigation deviation handling timeline closure time as per guidelines
Yes sure
Nice video Sir 👌👌👌
Thanks
Thank you
You're welcome
Dear sir is planned deviation exist in current time??
It depends on companies what they are adapting from the current scenario.
ruclips.net/user/shortsbvK7DDaHWwI?feature=share
Currently planned deviation consider to as a temporary change control,if you don't know not making any video only for showing on screen
Dear I don't know who are you,
But a kind suggestion for you that watch the full video with a conscious mind,
for your kind information this video or videos in this channel are only for pharma beginners and students and only for information purpose.
Each and every companies SOPs, protocols, procedures are different based on their requirements and proficiency of professionals working in the organization.
I am not here to tell you deeply any aspects of any terminologies used in pharmaceutical companies.
I you wish you can watch the videos or skip to next one.
Thank You.
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Ll
If meterial not dryied with in the limits deviation take or not
Follow SOP or initiate Deviation