|
CAPA in Pharmaceutical Industry
|
|
| Author:
|
RAGHU P, VIKAS JAIN, GANGADHARAPPA H V, MADHU R
|
| Abstract:
|
Corrective and preventive action is a term with the condition of the good manufacturing practice. CAPA in the
pharma industry intends to find the deviation, non-conformities, failures, in the industry. CAPA system
provides a process obtaining essential quality data that allows out of specification, also CAPA is the process by
which preventive actions are performed before those deviations occur, this analysis describes an overview of
the root cause analysis and implementation of the CAPA program in case of OOS results. CAPA focused on
the systemic analysis of inconsistencies (problem and/or variation) make an effort to avoid them from
repeating. To make conform the CAPA measure are successful, a detailed investigation of its occurrence of
errors is essential to the identification of CAPA performed. And appropriate CAPA programs are a key focus
of performance improvement. This study is providing a detailed view of measures taken in corrective and
preventive action, methodology for taking CAPA supporting progress over the life of product including the
quality management system in pharma industry. And every organization would require to have an efficient
change management system to Ensures uninterrupted improvements are made promptly and efficiently way
|
| Keyword:
|
corrective action, preventive action, Quality management system.
|
| EOI:
|
-
|
| DOI:
|
https://doi.org/10.31838/ijpr/2021.13.03.015
|
| Download:
|
Request For Article
|
|
|