New era of Indian Pharmaceutical industry is going to begin. Major regulatory pharmaceutical companies are under USFDA alert. Repeated/similar observation are reported against data integrity and GMP practices. Now a day’s process are dependent on the human being, however transition from human to automation is very high. But it is not like that automation can replace the human intervention fully.
People involved in the process they should to be Educated, trained and experience in relevant field.
Human are driven through emotions, so the mental stress and trauma directly impacting the process which they are involved.
It is the responsibility to management to look after their employee’s recreation and their day in day out needs. Need to be focused on the below mentioned points,
Work Time management: Regular over time disturbed personal as well as professional life structure. 70-80% employees should go home at the end of their working hours.
Knowledge management: Recognize the person with proper knowledge for their respective job/if required ensure periodic training and current updates.
Leadership management: Identify the leader not rulers. A good leader not give orders they believed to work together.
Cultural program/get-together: This will made the work place like homely environment
Below mention table are providing details, that how the risk level is associated with human involvement,
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Category
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Requirements
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Risk Level
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Justification
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Drawback
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Automation
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System should to be validated
Controls should to be established
Maintenances to be done as per requirement
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Low
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Due to high controls
Probability of failure is very less and meanwhile detectability of any probable failure is very high
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Improper maintenance/timely replacement can hamper your business continuity
e.g. Partially sealed injectable vial unit loading in the Lyophilizer through ALUS (Robotic system).
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Semi-automatic
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Addition to automation requirements human controls are required
Person should have
a. Relevant Qualified
b. Subject Trained
c. Experience
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Medium
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As personnel are involved in the operation hence the Probability of failure is medium and detectability of any probable failure is medium
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Machine/process performance partially depended on the Human activity.
e.g. Partially sealed injectable vial unit loading in the Lyophilizer through semiautomatic conveyor under RABS/Isolator.
|
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Manual
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Activity driven by human being.
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High
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As the probability of failure is high and detectability is very low.
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Process output fully depended on the manual interventions by human being.
e.g. Partially sealed injectable vial unit loading in the Lyophilizer by manually tray loading procedure under LAF.
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