When the analytical results are found out of specification or out of trend in a case systematic and detailed investigation needs to be done to find out the exact root cause. Hence there is a requirement for competent corrective action and preventive action (CAPA). Management of CAPA is the most important part of a competent quality management system (QMS).
The main aim of CAPA is to ensure to reduce or avoid the errors repeatedly observed during product development, analysis, validation, transfer, manufacturing, and stability study. Regulatory agencies like US FDA, MHRA, TGA, and ISO stresses more robust CAPA control using a scientific approach.
What is CAPA?
CAPA is a systematic quality management system approach to identify, investigate, recognize and rectify errors while preventing unwanted and repetitive errors.
Corrective action is the initial step to finding out the problem or root cause of the error and taking necessary action as corrective action to prevent similar errors in the future by, changing the document, checking of process, and repairing equipment or instruments.
Preventive action is the procedure to control the errors or incidents observed repeatedly by upgradation of equipment or instruments, revising the procedure, providing training, and modifying the manufacturing process.
Root Cause Analysis:
To find out the root cause proficient reviewer should review and understand the hypothesis and the manager verify and should know the background and verify the same. Root cause analysis is vital to find out the nonconformity and recommend corrective actions for the recognized problem. The Ishikawa fishbone diagram is useful in combination with the 5 Why’ technique to find out the root cause. Following are the main types of root causes which are represented by fish bones these are also specified as 6Ms.
- Manpower: Association of skilled, accountable, and quality-conscious persons in the analysis and manufacturing. Skilled persons with
- Methods: Standard procedures, techniques, guidelines, job guidance and strictly following all parameters and execution of work precisely.
- Machines: All Instruments and equipment must be clean, calibrated, and maintained with specific standard operating procedures.
- Materials: Raw materials, packaging materials, and finished products’ chemical properties and physical condition are fine. The material must be supplied by audited or qualified vendors.
- Measurements: Assessed data received from instruments, equipment, and computers are authentic, verified, calibrated, and skilled, attentive personnel doing their job consistently.
- Milieu (Environment): The conditions such as location, temperature, vibration, humidity, lights, and cleanliness will impact manufactured products.
Importance of CAPA:
The importance of CAPA management is to understand its following requirement.
- To maintain GMP compliance,
- It is a 21 CFR regulatory requirement,
- Reduce fundamental issues from occurring,
- Improve the practice and system,
- Enhance consciousness of a quality system,
- It increases productivity by reducing the operation cost and time,
- Implementing the CAPA helps to improve of quality the system.
Implementation of CAPA System:
To achieve effective and quality documents implementation of the following 7 steps of corrective or preventive action is very much significant.
- Identification: Identify the problem transparently,
- Evaluation: Evaluate the extent which leads to failure with its probable impact and necessary action to mark the risk,
- Investigation: The strategy to find out the root cause of the problem,
- Analysis: Conduct the systematic evaluation with evidence,
- Action Plan: Create a checklist of required action plans to rectify the failure,
- Implementation: Implement the plan of action
- Follow Up: Confirm and check execution and the effectiveness of the plan of action.
Corrective action and preventive action help the company to improve the competitive situation by reducing operational costs saving time and ensuring compliance. This improves the system to avoid repetitive issues through manufacturing and analysis.
- Code of Federal Regulations, Title 21, Food and Drugs, Part 820,
- Code of Federal Regulations, Title 21, Food and Drugs, Part 211,
- Sivakumar BV, Ph.D. Significance of Root cause analysis and challenges in implementing Appropriate CAPA” Pharma Bio World. 2017
- FDA, Current Good Manufacturing Practice Requirements for Combination Products,
- FDA, Guide to Inspections of Quality Systems (Rockville, MD, Aug. 1999).
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