In the pharmaceutical industry, a deviation refers to any departure from an approved instruction, standard, procedure, or specification. It is an unexpected event that may affect the quality, safety, or efficacy of a product or process.
✅ Definition:
Deviation is defined as any unintended or unplanned event that occurs during the execution of a process or procedure that differs from approved documents (like SOPs, batch records, protocols, etc.).
📌 Types of Deviations:
1. Planned Deviation:
A pre-approved change from an established procedure.
Done intentionally and with justification.
Example: Using a backup supplier temporarily with QA approval.
2. Unplanned Deviation:
An unintentional and unexpected event.
Usually indicates a failure or error in the process.
Example: Power failure during production, wrong labeling, skipped step.
⚠️ Examples of Deviations:
A batch step skipped by operator.
Calibration not done on time.
Using incorrect version of a document.
Temperature excursion during storage.
📋 Deviation Handling Process:
1. Identification – Noticing and reporting the deviation.
2. Recording – Logging it into a deviation form or system.
3. Investigation – Finding the root cause (using tools like 5 Whys, Fishbone).
4. Impact Assessment – Evaluating impact on product quality.
5. CAPA – Implementing Corrective and Preventive Actions.
6. Closure – Final review and documentation.
📌 Why is Deviation Control Important?
Ensures product quality and patient safety.
Maintains regulatory compliance (e.g., FDA, GMP).
Helps in continuous improvement of processes.
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