Corrective and Preventive Action - M1L3 MANUF LAB

CAPA

is a process which investigates and solves problems, identifies causes, takes corrective action and prevents recurrence of the root causes.

Identification

The initial step in the process is to clearly define the problem. It is important to accurately and completely describe the situation as it exists now.

EVALUATION

The situation must be evaluated to determine both the need for action and then, the level of action required. The potential impact of the problem and the actual risks to the company and/or customers must be determined

INVESTIGATION

• There must be a written procedure in conducting an investigation into the problem.

• Written procedure ensures that the investigation is complete and nothing is overlooked

Objective

is to determine why the tablets did not meet the hardness specification, correct the problem, and prevent it from happening again in future batches while following Good Manufacturing Practices (GMP)

Production Supervisor

Leads the investigation and overseesproduction.

Quality Assurance (QA) Officer

Reviews the investigation and approves the CAPA.

Quality Control (QC) Analyst

Performs laboratory tests on the tablets

Engineering/Maintenance Personnel

Inspects and repairs the tablet compression machine if needed.

Production Operator

Provides information about the manufacturing process.

ANALYSIS

The investigation procedure is used to conduct the investigation into the cause of the problem. The goal of this analysis is primarily to determine the root cause of the problem described, but any contributing causes are also identified.

ACTION PLAN

Using the results from the analysis, the best method(s) for correcting the situation (or preventing a future occurrence) is determined and action plan developed. All of the tasks required to correct the problem and prevent a recurrence are identified and incorporated into an action plan. The plan includes changes that must be made and assigns responsibility for the tasks. The action plan should also identify the person or persons responsible for completing each task.

IMPLEMENTATION

The corrective / preventive action plan that has been created is now implemented. All of the required tasks listed and described in the action plan are initiated, completed, and documented.

🞑 Implementation Summary

🞑 Documentation

FOLLOW UP

One of the most fundamental steps in the CAPA process is completing an evaluation of the actions that were taken. This evaluation must not only verify the successful completion of the identified tasks, but also assess the appropriateness and effectiveness of the actions taken.

🞑 Verification results

🞑 Validation results