This document discusses corrective and preventive actions (CAPA) in quality management. CAPA aims to eliminate causes of non-conformities or undesirable situations. It has two functions - corrective action finds root causes of problems and takes direct action, while preventive action informs an organization to prevent problems from recurring. Successful CAPA implementation requires effective planning, preparation, writing, evaluation, procedure updates, execution proof, change management and meetings. CAPA plays an important role in continuously improving products and processes in a quality management system.

1. PRESENTED BY:
Mr. Ankush P. Jadhav & Miss. Tejashree R. Kedar
M. Pharm (PQA)
Email id: jadhavbrand@gmail.com ………..tejashrikedar@gmail.com
CORRECTIVE ACTIONS AND PREVENTIVE ACTIONS

2. DEFINITION
NONCONFORMA
NONCONFORMANCE: Not meeting specifications or requirements.
DEVIATION: Not following specified instructions.
CONTAINMENT: Action taken to arrest the effects of nonconformance.
VARIANCE: A one time waver to perform a task through a planned deviations: Not
meeting specifications or requirements.
VARIANCE: A one time waver to perform a task through a
planned deviation.

3. INTRODUCTION
CAPA is the efforts taken by the organization to eliminate causes of NON-CONFORMITIES or
other undesirable situations.
Nonconformance may be a market complaint, failure of a machinery , failure of quality
management system, misinterpretation of written instructions.
CAPA is designed by a team including QA personnel and personnel involved in the actual
observation of nonconformance.
Failure to adhere to proper CAPA handling is considered as violation of USFDA regulations
on Good Manufacturing Practices ( GMP). As a consequence, a medicine or medical device can
be termed as adulterated or substan.

4. CAPA HAS 2 DISTINCT FUNCTIONS.
1) CORRECTIVE ACTION (CA):
The first goal is to find the root cause , errors , base events that preceded the problem.
The second goal is to take direct action directed at root cause.
2) PREVENTIVE ACTION (PA):
Primary goal is to inform an organization and prevent the problem from returning.

5. OBJECTIVES OF CAPA
Verification of CAPA system procedures that addresses the requirements of quality system
regulation.
Evidence that appropriate sources of product and quality problems have been identified.
Data sources for CAPA are of appropriate quality and content.
Verify that appropriate Statistical Process Control (SPC) methods are used to detect recurring
quality problems.
All the corrective and preventive actions are implemented and documented.

8. Common failures of CAPA implementation.
1) Lack of examination.
2) Lack of agreement information.
3) Lack of communication.
4) Lack of execution.

9. THINGS TO CONSIDER ABOUT CAPA
Successful execution of CAPA is highly dependent upon the effectiveness of planning that
goes into it.
CAPA is a major focus of FDA during inspections.
There are certain steps to remember which are follows:
1) Establishment of plan:
Proper training.
Regular validation programmed.
Logistical concerns.
Regulatory concerns.
Documentation list.

10. 2) Effective preparation:
Find the experienced personnel with right skills.
Define role and responsibility of each member and team role.
Provide training.
Outline the priorities.
3) CAPA Interaction plan:
Written communication plan – SOP or CAPA specific.
Outline types of communication.

11. 4) CAPA writing:
Defining specific title.
Avoid unnecessary descriptors.
Appropriate dates, times, document names and numbers , deviation
numbers.
Facts used to tackle the problems
Actions taken to resolve the problems.
5) Continuous evaluation:
Study the problem
Determine extent
Establishment of root cause.
Use of process flow diagram.

12. 6) Updates of procedures:
Secure approvals for new/updated procedures.
7) Proof of execution:
Assemble documentation like:
SOPs
Records
Audits
Training

13. 8) Change management:
Document control.
Change control.
9) CAPA meetings:
Review project team.
Analyze CAPA scope.
Examine interaction plan.
Review issues.

14. 10) Perform internal review and approvals:
Prepare CAPA project teams.
Approval should be performed by QA Department Head.

15. ROLE OF CAPA IN QUALITY MANAGEMENT SYSTEM
The role of a CAPA system is to continuously improve product and processes in the quality
system.
CAPA is a continuous quality improvement sub system.
CAPA decision making is based on risk assessment and impact assessment.
Risk assessment is performed on three levels: End user, compliance, and business.
The CAPA system receives information from two Quality management loops:
I. The internal feedback-loop : Quality data from within the organization.
II. The external feedback-loop: Quality data from outside the organization.

16. REFERENCE
• Manohar A. Potdar “Pharmaceutical Quality Assurance” Nirali
Publications, 6th edition, 2017.
• Sawant R., Hapse S., “Fundamentals of Quality Assurance Techniques”
2nd edition, Career Publications, May 2016.

17. THANK YOU