“Quality is not the absence of deviation — it’s how effectively we handle it.”
In the pharmaceutical, diagnostic, and food industries, even a small deviation from standard procedures can have a big impact on product quality, safety, and compliance.
That’s why every GMP-compliant organization maintains a robust Deviation Management System — to identify, document, investigate, and prevent reoccurrence of such issues.
What Is Deviation Management?
Deviation Management is a controlled system for handling any departure from approved instructions, processes, or specifications during production, testing, or quality operations.
It’s a core part of Good Manufacturing Practice (GMP) and Quality Management Systems (QMS).
Types of Deviations:
1. Minor Deviation – No significant impact on product quality or compliance.
2. Major Deviation – Could affect product quality, safety, or GMP compliance.
3. Critical Deviation – Serious impact requiring immediate action and regulatory reporting.
Deviation Handling Process:
1. Detection & Reporting – Any observed deviation must be reported immediately.
2. Documentation – Record deviation details (who, what, when, where, how).
3. Investigation – Analyze the root cause using tools like Fishbone Diagram or 5-Why Analysis.
4. Impact Assessment – Evaluate if the deviation affects quality, safety, or compliance.
5. Corrective & Preventive Action (CAPA) – Implement solutions to eliminate root causes and prevent recurrence.
6. Review & Closure – QA reviews effectiveness and closes the deviation officially.
Examples in Real Scenarios:
- Temperature deviation in stability chamber.
- Wrong batch label used during packaging.
- Calibration missed for an analytical instrument.
- Unexpected result during QC testing.
Why It’s Important:
✔️ Maintains GMP and ISO compliance.
✔️ Strengthens root cause analysis and continuous improvement.
✔️ Builds accountability and traceability in quality systems.
✔️ Reduces repeat deviations and production losses.
In a world driven by precision, deviation is inevitable — but unmanaged deviation is unacceptable.
Smart quality professionals don’t hide deviations; they learn from them to build a stronger system.
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Pharmacy