CAPA Process Steps in Pharmaceutical Industry

Each pharmaceutical manufacturer shall establish and maintain procedures for implementing corrective and preventive action (CAPA). And the procedures must ensure all requirements of CAPA subsystem are met.

CAPA Subsystem in Context

Production & Process Controls
Material Controls
Equipment & Facility Controls
Design Controls
Records, Documents, & Change Controls

CAPA Process

CAPA Sources

Internal Sources

Inspection/Test Data
Nonconforming Material Reports
Equipment Data
Scrap/Yield Data
Rework Data
Returned Product
Internal Audits
Process Control Data
Acceptance Activities

External Sources

Complaints
Field Service Reports
Legal Claims
Warranty Claims
External Audits
Medical Device Reports (MDRs)

CAPA Process Steps

1. Analyze Data

Ensure all quality data sources are defined and analyzed to identify existing product and quality problems. Analysis of data should also include a comparison of the same problem type across different data sources.

Common Statistical Techniques Used for CAPA Management

Pareto charts
Run charts
Control charts
Mean and standard deviation
T tests for comparisons
Experimental design (DOE)
Graphical methods (fishbone diagrams, histograms, scatter plots, spreadsheets, etc.)

2. Investigate Cause

Typical Investigation Steps include:

Identify problem and characterize.
Determine scope and impact.
Investigate data, process, operations and other sources of information.
Determine root cause, if possible.

Possible Root Causes:

Training
Design
Manufacturing
Management
Change Control
Purchasing/Supplier Quality
Testing
Documentation
Maintenance

Commonly used root cause analysis tools:

Fishbone diagrams
5 “whys”
Fault-tree analysis

Many manufacturers tend to overuse training as a corrective action and do not adequately address the systemic corrective action.

3. Identify Action

Identifying the action(s) needed to correct and prevent recurrence of non-conforming product and other quality problems is a critical step of CAPA process. We can follow the below sequence:

Identify solutions.
Develop action plan for corrective action and/or preventive action.
Should consider the risk posed by the problem.

– Not all problems require the same level of investigation and action.

– It is appropriate to “elevate” some issues at the expense of others.

A Preventive Action is NOT required for all situations; however, a Corrective Action to prevent recurrence is required.

4. Verify and Validate Effectiveness

Verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device. Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems.