CAPA

Question 1

CAPA
What are the main sources of CAPA’s in a pharmaceutical company.

Answer 1

• Internal Sources
• › Process Control Data
• › Test Data
• › Trend Data
• › Deviations
• › Internal Audit Findings
• › Rework
• › Training Records
• External Sources
  › Customer Complaints › Regulatory Inspection › Adverse Event Reports

Question 2

What are the typical steps involved in the CAPA process? Outline/ explain the typical CAPA process. Discuss how an effective CAPA system might be managed.

Answer 2

• Identification: Define the problem
• › Evaluation- Impact / Risk Assessment: Initial assessment of the impact and the magnitude of the problem.
• › Immediate Action required?: Protect the customer/product/user from the problem.
• › Root Cause Investigation: Identify the root cause of the problem by using a systematic approach.
• › Conclusion and Quality Decision: Final thorough conclusion on the impact and magnitude of the problem, decision regarding the use of the product, etc.
• › Action Plan: Define corrective and preventive actions.
• › Implementation and Follow-up: Implement corrective and preventive actions and verify their effectiveness

Question 3

What are the typical steps involved in the CAPA process? Outline/ explain the typical CAPA process. Discuss how an effective CAPA system might be managed.

Answer 3

• Identification: Define the problem
• › Evaluation- Impact / Risk Assessment: Initial assessment of the impact and the magnitude of the problem.
• › Immediate Action required?: Protect the customer/product/user from the problem.
• › Root Cause Investigation: Identify the root cause of the problem by using a systematic approach.
• › Conclusion and Quality Decision: Final thorough conclusion on the impact and magnitude of the problem, decision regarding the use of the product, etc.
• › Action Plan: Define corrective and preventive actions.
• › Implementation and Follow-up: Implement corrective and preventive actions and verify their effectiveness

Question 4

What should a good CAPA system achieve over time?

Answer 4

• A reduction in quality issues
• A reduction in the severity of issues
• More preventive actions over time
• Better designed products/processes
• Improves customer satisfaction/reputation
• Decrease in costs of quality.
• Better business results.

Question 5

What are the symptoms of a less than effective CAPA system?

Answer 5

• Recurring issues
• › Inability to “manage” the many sources of quality data to understand early trends and issues
• › More reaction than prevention
• › Resources are spent on “handling” failure rather than learning from it and preventing “more of the same”

Question 6

What are Corrective actions and Preventive actions?

Answer 6

Corrective action - to correct an existing non conformity and also to prevent it from recurring.
Preventive Action, - to prevent a possible problem from occurring by proactively putting improvements in place