Deviation in Pharmaceutical Companies, Part 2 of 2, in hindi & english
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This video is about Deviation
This video is about Deviation in Pharmaceutical Companies, Part 2 of 2, in hindi & english
#Deviation
#PharmaGyan
#DeviationinPharma
Visit our website for more stuffs like guidelines, jobs, vacancies, SOPs, Protocols, etc.
Link is : https://sites.google.com/view/pharmagyan
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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.
Hello Friends welcome to my channel "PharmaGyan" Learn about Pharmacy, Pharmaceutical companies, regulatory guidelines, Documentation procedures, SOPs, How to videos on various operating procedures, Quality Assurance, Quality control, R&D, Pharmaceutical validation and qualification guidelines and procedures etc.
#Deviation
#PharmaGyan
#DeviationinPharma
Visit our website for more stuffs like guidelines, jobs, vacancies, SOPs, Protocols, etc.
Link is : https://sites.google.com/view/pharmagyan
Let's Checkout Our Other Videos
Deviation Flow Chart | Unplanned Deviation Flow Chart : Deviation Flow Chart | Unplanned Devi...
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Change Control Flow Chart : Change Control Flow Chart with exampl...
Top 10 pharmaceutical companies in world in case of revenue : Top 10 Pharmaceutical companies in wo...
Clean room classification by ISO : Clean Room Classification | ISO Guide...
Validation of Autoclave and Qualification Part 1: Validation of Autoclave and Qualifica...
WFI Specifications : WFI Specifications for Pharmaceutical...
Steam Sterilization or Autoclaving Basic concepts Part 02 of 02: Steam Sterilization or Autoclaving ...
Pharma technical series interview questions and answers : Pharma Technical Series interview que...
Incident - Incident in Pharmaceutical Companies|...
GMP History - GMP History| How GMP Came?| Why Follo...
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Types of Validation - Validation in hindi | validation in p...
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Concept of ALCOA or Data integrity - Data integrity in Pharma companies an...
Concept of ALCOA or Data integrity - Data Integrity in Pharmaceutical Comp...
APQR - APQR | Annual Product Quality Review ...
CAPA - CAPA | Corrective Action and Preventi...
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.
Hello Friends welcome to my channel "PharmaGyan" Learn about Pharmacy, Pharmaceutical companies, regulatory guidelines, Documentation procedures, SOPs, How to videos on various operating procedures, Quality Assurance, Quality control, R&D, Pharmaceutical validation and qualification guidelines and procedures etc.
4 سال پیش
در تاریخ 1399/05/01 منتشر شده
است.
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