This video is about CAPA | Corrective Action and Preventive Action in Pharmaceutical Companies
TimeStamps:
00:25 What is CAPA?
00:45 CAPA Terminologies
06:48 Process flow of CAPA
07:52 Subsystems of CAPA
08:38 USFDA Subpart J - Corrective & Preventive Action
11:08 References
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CAPA
Correction: An action to resolve the problem.
Or
Repair, rework, or adjustment and relates to the disposition of an existing nonconformity.
Example:
If something happened wrong like in the laboratory analysis of a drug substance, sample from vial to be withdrawn using an injector but the sample withdrawn using pippete.
Corrective Actions : An action to stop the problem from reoccurring.
Or
Eliminate detected nonconformity.
Or
The action taken to eliminate the causes of an existing nonconformity, defect or other undesirable situation in order to prevent recurrence.
Preventive Action : An action to prevent the problem from occurring.
Or
Prevent nonconformity occurrence
Or
Action taken to eliminate the cause of a potential nonconformity, defect, or other undesirable situation in order to prevent occurrence.
Example:
If something happened wrong like in the laboratory analysis of a drug substance, sample from vial to be withdrawn using an injector but the sample withdrawn using pipette.
Training Imparted & STP revised to incorporate procedure to withdraw samples.
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8 окт 2024