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CAPA Corrective and preventive action in Pharmaceutical

CAPA stands for corrective action and preventive action. CAPA is a quality management system used in pharmaceutical industries. The purpose of corrective and preventive action is to analyze, collect, find out and problem, then take the desirable and appropriate corrective and preventive action to prevent recurrence.

Definition of Corrective and Preventive action

Corrective action: is the action taken to eliminate the causes of an existing problem/nonconformity, defect, or other objectionable events to prevent a recurrence.

Preventive action: preventive action is the action taken to eliminate the cause of potential nonconformity, defect, or other undesirable events in order to prevent Occurrence.

NOTE:  Corrective action is taken to prevent a Recurrence defined in [ISO 9000:2005, clause 3.6.5] whereas Preventive action is taken to prevent the Occurrence

Nonconformity: Nonconformity is the non-carryout of a specific requirement.

Non-conformance: non-conformance either misinterpretation of written instruction leads to market complaints or customer complaints and failure of equipment or quality management system.

Related: Nonconformity during the audit and their types

Initiation process of Corrective and Preventive Action:

  • Submit the source of information documents to the QA Head by the concerned department.
  • According to a source of information or risk factor, the QA Head and the concerned department decide whether it is needed or not.
  • QA initiates the form along with its identification or reference number for further investigation.
  • QA numbered it for identification in the following manners ( CAPA/DEPT.CODE/serial no./last two digits of a calendar year).
  • The concerned department Head fills the form with its Initiation date and its proposed completion date. Select department by marking ✓ in the appropriate box. mark ✓ on the affected site, and select not applicable if the system is not affected. Write the description according to the source of information, along with corrective and preventive action. The concerned department head shall fill their name with a sign and date.
  • After filling out the form, the concerned department Head shall send it to QA for review.

CAPA as per ICH Q10?

A structured approach to identify the process should be used to determine the root cause.

13 Steps for CAPA in pharmaceutical industries:

The basic steps involved in the application of effective Corrective and preventive action to improve the required documentation:

1. identification

Identification is the initial step in the Corrective and preventive process, which involves defining a specific problem and source of information. There is a requirement to do documentation of available evidence for further use throughout the investigation process.

2. initiation of CAPA

CAPA shall be initiated After getting a source of information, it may be ( Internal input (Internal audit), External input (Customer complaint) with the CAPAs source), change control, deviation, incident report, product recall, man, machine, Process method, Materials, and environmental.

Related: Deviation, and Its types

3. CAPA Review

QA Head review for CAPA to determine what action has to take.

4. CAPA acceptance or rejection

Acceptance: if accepted, move forward with the other Corrective and preventive action initiation process by assigning a unique identification number for tracking and reference throughout the investigation.

Rejection: document the reasoning (विचार ) and rationale (तर्क ) in case the issue repeat.

5. Evaluation and action

CAPA Evaluation is done to determine how big the problem, impact, Risk, and level of action are required—for example, impact on products and their quality, safety, function, and customer’s need.

Assessment of Risk is also essential and required for immediate remedial action with a remedial action form.

6. Investigation process in corrective and preventive action

Conduct a written procedure to ensure the direction of an investigation. The process must include the design of the action, strategy ( to write steps involved in the analysis of root causes), and consideration of a machine, material, personnel, process, training, software, and other external factors.

7. Analysis or determine the root causes

Root cause analysis is to be done By using the right analytical tools to analyze a problem. An accurate analysis leads to an effective action plan. The following methods can do this. Fishbone/ Affinity (Ishikawa diagram), Five WHYs, Fault tree analysis, and 5 M analysis.

Ishikawa or fishbone diagram:  is used for the analysis root cause of a problem. Here is an example of a problem to investigate “Tablet diameter out of specification”.

fishbone structure, CAPA IN PHARMACEUTICAL

8. Develop an action plan

The Action Plan Must Be Develop To Prevent the Future reoccurrence of the same problem, For This Assign, Responsibility to the team to Correct The Problem And Prevent From Recurrence Again. Suppose, you are required to do a change in Process, Documents, Procedures, and other modifications related to the system and training to employees including, an action plan form with corrective and preventive action. Develop “5 WHYs” for the action plan.


5 why's analysis knowledge graph

To analyze 5 WHY is not just the 5 Questions to start “WHYs,” but each question must be related to the next one. In this case, the root cause of out-of-specification may be “an untrained person involved” in the process.

9. Completeness of the action plan

After the action plan, gives roles and responsibilities to execute the plan. Create a task list for its implementation.

  • Update procedure
  • Add an inspection step
  • Re-design a process
  • Implementation of additional training for key staff
  • Switch material
  • Modify manufacturing /storage environments.

10. Verification, Effectiveness, and Validation of CAPA:

Ensure that the corrective and preventive action is effective and does not adversely affect the end products. Verify and review data associated with it and also verify that, verification and validation protocol is established along with this.

Also, review the effectiveness of Corrective and preventive action by ensuring data is reviewed to find out if there is a similar problem.

11. implementation of changes:

Implementation of the change steps ensures that the control documents are reviewed and approved if any changes are made.

12. Management Review Corrective and preventive action

Department Head shall certify that CAPA is implemented as per a process. QA shall verify it along with the supporting documents and certify the same. Copy of it shall be handover to the concerned department Head. At Last, the QA Head and a team of QMS will review CAPA to ensure that the process is followed correctly at all stages.

13. Closing of CAPA

After the finish of all follow-ups, and on completion of Corrective and preventive action. It should be dated and signed by an authorized Department Head.

Deviation Co relationship with CAPA?

Deviation alone is not a solution to the problem. Deviation can describe an issue, so to prevent it from reoccurrence, CAPA is taken according to the nature of a problem. Corrective and preventive action help to find out the root causes of a problem through the investigation process. Management of deviation must be recorded for future trends and analysis.

Complain only trigger the CAPA. Remember, every complaint does not belong to CAPA.

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