🛠️ CAPA Process at Talwar Pharma

Corrective and Preventive Action (CAPA) is a key element of Talwar Pharma’s quality management system, aimed at identifying, addressing, and preventing the recurrence of issues that may affect product quality, compliance, or safety.

🔹 1. Issue Identification

The CAPA process begins when a deviation, audit finding, complaint, or any non-conformance is detected during routine operations or inspections.

🔹 2. Root Cause Analysis (RCA)

A detailed investigation is conducted to determine the underlying cause using techniques like the 5 Whys, Fishbone Diagram, or FMEA (Failure Mode and Effect Analysis).

🔹 3. Corrective Action

Once the root cause is identified, corrective actions are implemented to eliminate the current issue. This may involve process changes, retraining staff, or revising SOPs.

🔹 4. Preventive Action

Preventive steps are taken to ensure similar issues don’t occur in the future. This includes process redesign, automation, system upgrades, or strengthening monitoring controls.

🔹 5. Effectiveness Check

After implementation, CAPA actions are monitored and reviewed over time to ensure they are effective and sustainable.

🔹 6. Documentation

All CAPA activities are documented thoroughly and reviewed by QA. Proper records are maintained for audits and regulatory reviews.