ASEAN Guidelines on GMP for Traditional Medicines: Evaluation of Corrective Action and Preventive Action

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The ASEAN Guidelines on GMP for Traditional Medicines discuss the importance of Corrective Action and Preventive Action (CAPA) for maintaining quality in health supplements. CAPA involves identifying nonconformities, implementing solutions, and preventing future occurrences through continuous improvement. The process includes inputs like product complaints, audit findings, and post-market surveillance. A basic CAPA system consists of steps such as initiating CAPA, investigating root causes, implementing solutions, and tracking effectiveness.

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ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements (TM/HS) EVALUATION OF CORRECTIVE ACTION AND PREVENTIVE ACTION (CAPA) Prepared by: Malaysia Approved by: ASEAN TMHS GMP Task Force Endorsed by: ASEAN TMHS Product Working Group 1

OUTLINE What is CAPA Basic CAPA System Root Cause Analysis and the Tools CAPA Regulatory challenges and common issues Summary ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA 2

INTRODUCTION: WHAT IS CAPA? ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA 3

WHAT IS CAPA? (2) CORRECTIVE ACTION Eliminate detected nonconformity PREVENTIVE ACTION Prevent nonconformity occurrence The HEART of an effective quality management system CAPA improvement of product & process methodology is for continuous To enhance product & process understanding and eliminate potential non-conformance. As per ICH Q10; Pharmaceutical Quality System ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA 4

WHAT IS CAPA? (3) ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA

CAPA INPUTS It all starts with INPUTs . Out-Of-Specifications Product Complaints Audit Findings Post Market Surveillance Product Recall Deviation Non-conformity NCR Issue Review Data Gathering CAPA REQUIRED CAPA NOT REQUIRED INITIATE CAPA Risk Assessment/ Recommended Course of Action Containment/ Correction ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA

BASIC CAPA SYSTEM (1) ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA 7

BASIC CAPA SYSTEM (2) 1. Initiate CAPA 5. Verify / Validate 2. Description of NC 6. Implement Cause Known Unknown 7. Effectiveness Check 3. Investigate Root Cause 8. Close CAPA 4. Solution (Action Plan) 9. Track & Trend ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA

BASIC CAPA SYSTEM 1. Initiate CAPA 5. Verify / Validate 2. Description of NC 6. Implement Cause Known Unknown 7. Effectiveness Check 3. Investigate Root Cause 8. Close CAPA 4. Solution (Action Plan) 9. Track & Trend ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA

DESCRIPTION OF NON- CONFORMANCE Describe the non-conformance precisely What, when, where, who, why & how. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA

BASIC CAPA SYSTEM 1. Initiate CAPA 5. Verify / Validate 2. Description of NC 6. Implement Cause Known Unknown 7. Effectiveness Check 3. Investigate Root Cause 8. Close CAPA 4. Solution (Action Plan) 9. Track & Trend ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA

INVESTIGATION CHECKLIST Describe the fast fix that was taken, Is it working? Identify owner and those involved. Gather information: Data Employee Input Flowcharts of the process Procedures Records (quantitative data) Has the problem occurred in the past? Identify Root Cause. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA

RULES OF INVESTIGATION Use proven root cause analysis tools Think out of the box Take the time needed Put a plan together ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA

WHAT MAKES A GOOD ROOT CAUSE? Document the primary cause (s) of the nonconformance Understand the problem statement Don t assume that people know or understand the problem well enough to determine root cause Data collection and analysis Involve people who have an understanding of the problem Used Cause and Effect principle Facilitate the Root Cause Analysis Provide the knowledge of RCA tools When solved, the problem will not recur ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA

ROOT CAUSE ANALYSIS (RCA) ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA

RCA: COMMON TOOLS ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA

RCA: CAUSE MAPPING ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA

RCA: CAUSE MAPPING Cause Mapping Visual explanation the cause of an incident OR problem Relationship between Cause-and-Effect Can be too simple or too complex, depending on the issue Cause Effect Cause-Effect Relationship ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA

RCA: CAUSE MAPPING Problem Cause Caused by CAUSE MAPPING - EXAMPLE Forest Fire Caused by Lightning Strike Car won t start Starter motor not turning No water in battery Dead battery Why? Why? Why? No rain in 2 weeks Haven t watered in 2 weeks Hot, Sunny weather for 2 weeks Grass is dying ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA

RCA: FISHBONE DIAGRAM Ishikawa/ Fishbone Diagram ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA

RCA: FISHBONE DIAGRAM Ishikawa / Fishbone Diagram can be used to identify potential factors causing an overall effect. Can be use to analyze several causes based on: Method Machine Personel Environment Material etc ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA

FISHBONE DIAGRAM FISHBONE DIAGRAM - EXAMPLE ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA

RCA: FISHBONE DIAGRAM FISHBONE DIAGRAM -EXAMPLE ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA

RCA: FISHBONE DIAGRAM ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA 24

RCA: FISHBONE DIAGRAM (5 WHYs Method) Why, why, why, why, why Kaji Cegah ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA

RCA: 5 WHYS METHOD Also known as Why why chart The main objective is to identify potential problem with the word of why ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA

RCA: 5 WHYS METHOD 5 WHYs Method -Example ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA

RCA: 5 WHYS METHOD 5 WHYs Method -Example Root Cause ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA

RCA: 5 WHYS METHOD 5 WHYs Method -Example ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA

RCA: 5 WHYS METHOD Finding: A cockroach was found under a mixer in Mixing Room 1 5 WHYs Method -Example Why the cockroach died? Answer: Eating bait Why it ate bait? Answer: There was a bait in the Mixing Room 1 Why there was a bait in Mixing Room 1? Answer: Requirement of pest control procedure. Why the SOP required cockroach bait inside the production area? Answer: The personnel who prepared the SOP didn t aware the GMP principle. Why he didn t aware the GMP requirement? Answer: The personnel never been trained accordingly. Root Cause ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA

BASIC CAPA SYSTEM 1. Initiate CAPA 5. Verify / Validate 2. Description of NC 6. Implement Cause Known Unknown 7. Effectiveness Check 3. Investigate Root Cause 8. Close CAPA 4. Solution (Action Plan) 9. Track & Trend ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA

CORRECTIVE ACTION PREVENTIVE ACTION Type Positive Negative feels good easier more doing than thinking might be fast reactive may add complexity to problem risks Trial & Error uses company wisdom/ lessons learned employs reasoning use experience tunnel-vision expensive and possibly slow Does not work as well for start up problems no deductive thinking or testing logically Expert/ Experiential fact-based Objective very proactive leverages requires discipline need to focus more on process people may resist new method Comparative ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA experience/expertise

CORRECTIVE ACTION PREVENTIVE ACTION Specific Precise action to eliminate the root cause No ambiguity Timely Measurable Responsible person will carry out the task by when Quantifiable result The action has to be time bound Accomplishing date/time Attainable Capability to implement should be reviewed Action should be feasible & achievable Realistic Action has to be logic and practical All the resources required are considered ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA

CORRECTIVE ACTION PREVENTIVE ACTION Implement a solution to address the cause not the symptom Implementation of a solution that does not address the cause of the problem is costly ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA

BASIC CAPA SYSTEM 1. Initiate CAPA 5. Verify / Validate 2. Description of NC 6. Implement Cause Known Unknown 7. Effectiveness Check 3. Investigate Root Cause 8. Close CAPA 4. Solution (Action Plan) 9. Track & Trend ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA

EFFECTIVENESS CHECKS Effectiveness Checks Criteria applies based on case or nature of CAPA Plan of effectiveness check is specific to CAPA Early detection points are identified to monitor for recurrence/occurrence ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA

EFFECTIVENESS CHECKS What to do when a effectiveness check fails, and what are the consequences? Close the CAPA and open a new one? Get an extension? Leave the CAPA open and investigate why? ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA

REGULATORY CHALLENGES No submission of CAPA feedback Feedback too simple or no cover letter e.g. One Page Insufficient CAPA feedback e.g.: We take note on your comment No dateline/ timeframe No CAPA No supporting document ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA

COMMON CAPA ISSUES No procedure Did not understand the issue No commitment from top management No monitoring Did not identify RCA or wrong RCA ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA

EXAMPLE OF CAPA FORMAT 1. Introduction Report Date Manufacturer Report Number Inspection Date GMP Status : (Versi terkini) : ABC Sdn. Bhd. : GMP 300/ Record-10/YY/XXX (CAPA) : dd/mm/yyyy : Acceptable/ Unacceptable 2. CAPA Implementation Finding Root Cause Correction Corrective Action Preventive Action Timeline of Completion Personnel aware of GMP Requirement not 1.1 Training Jan 2018 ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA

EXAMPLE OF CAPA FORMAT (2) Finding status Chapter Critical Major Minor Total Open 0 0 0 0 1 Closed 1 0 0 1 Open 2 Closed Open 3 Closed Prepared by: Checked by: Approved by: Date: Date: Date: ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA

CAPA CLOSURE The CAPA implementation need to follow by the monitoring of its effectiveness Various source of data need to be considered when analyze the CAPA CAPA documentation need to be checked and verify accurately before being stored ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA

CONTINUOUS IMPROVEMENT I can close the CAPA because have taken the action I m confident that I ve solved the problem and ensure it won t be repeat again ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA

CONFIRMATION OF CAPA The next inspection? ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA

BENEFITS OF GOOD CAPA SYSTEM Assurance that quality issues are resolved Customer complaints are reduced Promotion of continuous improvement An aligned method for problem solving Regulatory requirements are met Business needs are met ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA

SUMMARY A mature CAPA system can serve as a useful tool for analysing past events, correcting existing non conformities and preventing future events. CAPA will be useless if there is no commitment from top management of company or just simply prepared to meet the regulatory requirement ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements 2015 Evaluation of CAPA