Deviation in Pharmaceutical Companies, Part 2 of 2, in hindi & english

This video is about Deviation in Pharmaceutical Companies, Part 2 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.
Unplanned deviations can be categorized on their impact of product quality.
Critical
Major
Minor
Critical Deviation :
When the deviation affects a quality attribute, a critical process parameter, an equipment or instrument critical for process or control, of which the impact to patients (or personnel or environment) is highly probable, including life threatening situation, the deviation is categorized as Critical requiring immediate action, investigated, and documented as such by the appropriate SOP.
2. Major Deviation :
The deviation could or may have a significant impact on critical quality attributes of the product.
Or
When the deviation affects a quality attribute, a critical process parameter, an equipment or instrument critical for process or control, of which the impact to patients (or personnel/environment) is unlikely, the deviation is categorized as Major requiring immediate action, investigation, and documented as such by the appropriate SOP.
3. Minor Deviation:
When the deviation does not affect any quality attribute, a critical process parameter, or an equipment or instrument critical for process or control, it would be categorized as Minor, and treated as such by the applicable procedure.
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[@pinkubisoyi1995]

Awesome bro ... Carry on yrr ... Thanks for information ... So Comely explained

[@PharmaGyan]

Thanks and welcome

[@j2dhangar]

Give guidelines reference when you talking on any subject matters... Good

[@PharmaGyan]

Noted &
Thanks for your appreciation

[@RahulThakur-pq3vm]

Sir make video on flow chart of deviation

[@PharmaGyan]

Ya sure you will be updated for the same

[@PharmaGyan]

Deviation flow chart ruclips.net/video/ZnUrluF7W5M/видео.html

[@madhuripatel4624]

Sir make a video on documentation deviation

[@PharmaGyan]

Ya sure we will upload soon