This document discusses Corrective Action and Preventive Action (CAPA) as a fundamental quality management tool. It defines CAPA and explains that corrective action is taken to address root causes of issues that have occurred, while preventive action is taken to prevent potential causes of failure. The document outlines the CAPA process, which involves identifying issues, evaluating them, investigating to find causes, developing an action plan, implementing the plan, and verifying its effectiveness. It discusses the role of CAPA in continuous quality improvement and notes the benefits of CAPA include improving product quality and reducing risks.

1. MVG’S PHARMACY COLLAGE ,PANCHVATI
NASHIK
Topic- Corrective Action And Preventive Action(CAPA)
Name –Sanket Uttam Mandlik
Subject –Quality Management System
Roll No-39
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2. VISION-
To be a Centre of professional excellence by contributing honestly to the pharmacist
moulding process.
MISSION-
Impart high quality education to graduates
Contribute to all spheres of professional activities
Uphold human values and ethics
Nurture them into globally competent professionals.
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3. Contents
1. What is CAPA .
2. What is CA and PA.
3. Role of CAPA.
4. CAPA Procedures.
5. Benefits of CAPA.
6. References.
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4. What Is CAPA
CAPA is a fundamental management tool that should be used in every quality system.
This program provides a simple step by step process for completing and documenting
corrective or preventive actions.
The purpose of the corrective and preventive action subsystem is to collect Information,
analyze information, identify and investigate product and quality problems, and take and
effective corrective and/ or preventive action to prevent their recurrence.
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5. CORRECTIVE ACTION
1) Actions taken on the root causes
to prevent reoccurrence is called
corrective actions.
2)Action taken after the fact.
PREVENTIVE ACTIONS
1)Action taken on the potential causes of
failure or non-conformity to is called
prevent occurrence preventive action.
2)Action taken before the fact.
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6. 6

7. Reviewing
And
defining the
Problem
Finding
the
cause.
Developing
action plan.
Implementi
ng the
Plan
Corrective Action (CA) Steps
Evaluatin
g the
effective
ness
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8. 8

9. When CAPA
OOT
• Tablet assay
• 98-101 %
• 95%
OOS
• Result is compare last
10 batches ,if they not
match then OOT.
• Asaay (+- 5%)
• 90----95----100
OOE
• Results out of
expectation
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10. Role of CAPA
CAPA is a continuous Quality improvement system.
CAPA system receives information from two quality management loops:
I. The internal feedback loop: Quality data within the organization.
II. The external feedback loop: Quality data from outside the organization.
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11. CAPA Procedures:
Implementing an effective CAPA program capable of satisfying quality assurance and
regulatory documentation requirements is accomplished in seven basic steps:
1. Identification
2. Evaluation
3. Investigation procedure
4. Analysis of the problem
5. Action Plan
6. Implementation the plan
7. Verify Effectiveness
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12. 1. Identification:
The initial step in the process is to clearly define the problem.
 It is important to accurately and completely describe the situation as it exists now.
This should include-
I. the source of the information,
II. detailed explanation of the problem,
III. the available evidence that a problem exists.
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13. 2.Evaluation:
The situation that has been described and documented in the “Identification” section.
This may include the possible impact that the problem may in terms of:
I. Functions
II. Costs
III. Product quality
IV. Safety
V. Reliability
VI. Customer satisfaction
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14. 3.Investigation
The procedure should include:
Objective for actions to be taken : statement in from of “the problem will be corrected ,all
effect of problem identified and rectified and control will be in place to prevent the situation
from happening again’
Procedure to be followed : Determine the contributing and root cause of the problem
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15. 4.Analysis
 The objective of analysis is primarily to determine the root cause of the problem.
 This process involves collection of relevant data, investigating all possible causes,
and using the information available to determine the cause of the problem.
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16. 5.Action Plan
By using the results from the Analysis, the optimum method for correcting the situation
(or preventing a future occurrence) is determined and an action plan developed
The action plan should include:
I. Document changes
II. Process changes
III. Procedure changes
IV. System changes
V. Employees training
VI. Necessity of monitors or controls
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17. 6.Action Implementation
The corrective /preventive action plan that been created is now implemented.
Tasks listed & described in the action plan are initiated, completed & documented.
This section should contain a complete record of action which were taken to correct the
problem & to assure that it will not recur. This may include changes, preventive measures,
process controls, training etc.
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18. Benefits of CAPA
I. To improve quality of Product.
II. To Recognize existing or potential quality issues.
III. To initiate appropriate steps necessary to investigate and resolve these issues.
IV. To make sure that the same issues DO NOT Reoccur.
V. Reduce risk to patient.
VI. Products Designed and tested to meet customer requirements.
VII. Waste elimination.
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19. References
1. SHARMA P.P, In; How to practice GMP’s, Emerging concepts in Quality Assurance
of Drugs, 7th edition 2015, Vandana Publications, Delhi, pg.no 603-611
2. Roberts George w.; Quality Assurance in Research and Development, 8th edition ,
MARCEL DEKKER, INC, New York-82-84
3. Potdar Manohar A.; Pharmaceutical quality assurance, 2nd edition 2007 Nirali
Prakashan Pune pg.no. 10.2-10.3
4. http://www.drugregulations.org
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