CAPA

CAPA: 

CAPA When System Fail

Objectives: 

Objectives Introduction Nine Step CAPA program Requirement of an effective CAPA program Regulatory Expectation

Corrective And Preventive Action: 

C orrective A nd P reventive A ction CAPA is a well known CGMP regulatory concept that focuses on investigation, understanding and correcting the discrepancies while attempting to prevent their reoccurrence . Corrective Action - Measures taken to prevent the reoccurrence of the identified problem . Preventive Action - Measures taken to prevent the reoccurrence of a similar potential problem .

CFR 21 Part 211: 

CFR 21 Part 211 Sec.211.22 Responsibility of quality control unit. – There shall be quality control unit ..and the authority to review production records to assure that no error have occurred or ,if errors have occurred, that they have been fully investigated . Sec.211.100 Written procedures; deviations.-Written production and process procedures shall be followed …Any deviation from the written procedures shall be recorded and justified . Sec.211.192 Production record review.-All drug product production and control records shall be reviewed and approved by the quality control unit…Any unexplained discrepancy .shall be thoroughly investigated …. A written record of the investigation shall be made and shall include the conclusion and follow up.

Management Controls : 

Management Controls

483 items and Warning Letters: 

483 items and Warning Letters

Sources of Information : 

Sources of Information Deviations Complaints Recalls Internal Audits External Audits Change control Annual product review Trending Analysis Risk Analysis Management review

Nine Step CAPA Program: 

Nine Step CAPA Program Identify Problem Gather Information Analyze Data Perform Root Cause Analysis Complete Action Plan Implement Action Plan Follow-up-Action Plan Verify Effectiveness of Action Plan Confirm Preventive Action

1 Identify Problem: 

1 Identify Problem Where the event happened. What happened. When it happened. Who was involved. How many and whatever involved . How the event occurred.

2 and 3 Gather information and Analyze Data: 

2 and 3 Gather information and Analyze Data Looking at batch records Complaints Procedures followed and Process involved Changes Question ,interrogate with the one who involved in the process. Fault tree analysis and fishbone or other chart

4 Perform Root cause Analysis: 

4 Perform Root cause Analysis Analyze all the data collected ,pull it together to get the root cause . Return to data time and clarify again . Eliminate the possibilities until you arrive at the root cause .

5 and 6 Complete action plan and implement action plan: 

5 and 6 Complete action plan and implement action plan What will be done . Who will do it . How it will be done. Where it is going to be done. Effective follow up Confirmation of everything

7 Follow up Action plan: 

7 Follow up Action plan During and after implementation plan. Precise and thorough. Confirm the action plan implemented at right place. Effective follow up .

8 and 9 Verify effectiveness of action plan and confirm preventive action.: 

8 and 9 Verify effectiveness of action plan and confirm preventive action. Verification of the effectiveness of the conducting the action plan . Verify action plan cured or eliminated the problem.

Requirements of an effective CAPA program: 

Requirements of an effective CAPA program Plans in place . How to perform their investigation. How they will determine the root cause. How they will implement the action plan . Procedures to be developed and documented.

Requirements of an effective CAPA program: 

Requirements of an effective CAPA program Data collection Communication Procedures Trends

Regulatory Expectations: 

Regulatory Expectations Root cause identification . QSIT and CAPA Importance of continuous improvement. Procedural imperatives Risk based decision making .

Thank You : 

Thank You SM PRAVEEN APOTEX