📌 Deviation Control in Pharmaceuticals

Definition:
Deviation control in pharmaceuticals refers to the systematic process of identifying, documenting, investigating, and resolving any departure from approved processes, procedures, or specifications in a GMP-regulated environment.

🔹 Types of Deviations

1. Planned Deviation

   • Temporary and intentional departure from SOPs or processes.

   • Requires prior approval.

   • Example: Using alternate equipment during maintenance.

2. Unplanned Deviation

   • Unintentional and unexpected departure.

   • Reported immediately, followed by investigation and corrective action.

   • Example: Power failure during manufacturing, equipment breakdown.

🔹 Deviation Control Process

1. Identification & Reporting

   • Any employee can report a deviation immediately.

   • Use standard deviation reporting forms.

2. Documentation

   • Record details such as date, batch number, equipment, material, and description of deviation.

3. Investigation

   • Perform root cause analysis (RCA) using tools like Fishbone diagram, 5 Whys, etc.

   • Assess potential product impact.

4. Risk Assessment

   • Classify deviations as Minor, Major, or Critical based on severity and product impact.

5. Corrective & Preventive Actions (CAPA)

   • Implement corrective action to address immediate issue.

   • Implement preventive measures to avoid recurrence.

6. Review & Closure

   • Quality Assurance (QA) ensures completeness of investigation and effectiveness of CAPA.

   • Final approval by QA Head.

🔹 Importance of Deviation Control

• Ensures patient safety and product quality.

• Maintains regulatory compliance with GMP, FDA, and EMA standards.

• Supports continuous improvement in pharmaceutical manufacturing.

• Provides data for trend analysis and preventive actions.

🎓 Discover one of the best Complete Pharmaceutical Quality Assurance Course available —click below to explore the course that’s shaping future in QA Course skills.

https://trcjw.on-app.in/app/oc/306166/trcjw?utm_source%3Dcopy-link%26utm_medium%3Dtutor-course-referral%26utm_campaign%3Dcourse-overview-app