CAPA management-the heart of Pharmaceutical quality management system

Clearly define business processes are very necessary to achieve organizational goals and objectives but your business processes should be in command of quality management system to enhance efficiency, transparency and productivity. In Pharmaceutical industry quality system plays a very important role towards achieving overall organizational growth. Those quality system includes change control, deviation, internal audit, CAPA, OOS and OOT,risk management, customer complaints and recall. Effective management of these quality systems is very necessary to be compliance with national and international regulatory guidelines.

Effective execution of CAPA is a complex task for Pharmaceutical industry as CAPA is accumulating all other quality management system. Before explaining it in detail lets understand CAPA first:

What is CAPA?

CAPA stand for “Corrective actions and preventive actions”.
“Corrective actions is the process to eliminate the cause of detected nonconformity or other undesirable situation.”

“Preventive actions is the process of eliminating the cause of a potential nonconformity or other undesirable situation. ”

Still most of the companies are manually executing CAPA practices and facing many complexities like:

• Improper or error prone investigation
• Multiplying issues because of unstructured fixing of problems
• Desperate quality system and data sources
• Increase non-conformities, complaints or recall
• Reactive approach rather than proactive

The real problem is most of the companies seems quality as a department not a responsibility.
There are seven steps include in effective execution cycle of CAPA starts with:

1. Identification – Clearly define the problem

• Identify the source of information
• Detailed explanation of the problem
• Documentation of the available evidence that a problem exists
• Corrective/Preventive Action request form

2. Evaluation – Evaluate its potential impact

• Potential impact of the problem
• Assessment of risk
• Remedial action that may be required
• Remedial action form

3. Investigation – In-depth planning for problem research

• The objectives for the action
• An investigation strategy
• Assignment of responsibility and required resources
• Investigation procedure form

4. Analysis – Complete documentation after a thorough assessment

• Through root cause analysis with appropriated data collection
• Document your root cause analysis
• Root cause analysis form

5. Action Plan – Jot down the required tasks

• List all activities and tasks that must be accomplished to correct the existing problem
• Needed changes to documents, processes, procedures, or other system modifications should be described
• Employee training is an essential part of any change that is made and should be made part of the action plan
• Action plan form

6. Implementation – Execute the action plan

All of the activities that have been completed as required in the “Action Plan” should be listed and summarized

7. Follow Up – Verify and assess the effectiveness

• Have all of the objectives been met?
• Have all recommended changes been completed and verified?
• Has training and appropriate communications been implemented to assure that all relevant employees understand the situation and the changes that have been made?
• Has an investigation demonstrated that the actions taken have not had any additional adverse effect on the product or service?

An effective quality management system detects the problems before its occurrence and prevents the problems. According to FDA CAPA alone responsible for 30 to 50% of non-compliance. Quality management system streamline, simplify and automate all your quality management practices and provide you the centralized platform where you can effectively execute various quality processes.

Benefits of automated CAPA management:

• Enhance organization’s compliance quotient
• Reduction in issues, complaints and recall
• More preventive actions over time
• Optimum use of resources
• Facilitate better and more informed decisions by organizations
• Improved customer satisfaction

CAPA management is center of the quality management system where all the actions are narrowed down.