In the pharmaceutical industry, “deviation in pharma” refers to any departure from approved processes, procedures, specifications, or expected outcomes. These deviations can occur during manufacturing, testing, packaging, or storage of pharmaceutical products. Managing deviations is critical to ensure product quality, safety, and regulatory compliance.
Types of Deviations in Pharma:
Planned Deviation: When a process needs to be temporarily altered with prior approval (e.g., using an alternative supplier for a short time).
Unplanned Deviation: Unexpected departures from procedures
- Stamping done on Shippers or Cartons was not found readable
- Calibration of pH meter not done as per SOP
- Light Blue Coloured Hardgel Capsules used instead of Dark Blue Coloured
Deviations in Pharma
In a pharmaceutical company, deviations are any unplanned events where an approved procedure, specification, or expected result is not followed or achieved. Managing deviations in a structured, documented way is a core GMP requirement and a key part of maintaining product quality and compliance.
What Is a Deviation?
A deviation is any departure from:
- Approved SOPs, batch records, or validation protocols
- Defined process parameters or in-process controls
- Specifications for materials, products, or environment
- Established GMP/GDP practices
Deviations may occur in manufacturing, packaging, warehousing, QC, engineering, or support functions.
Types of Deviations
Pharma companies usually categorize deviations such as:
- Planned Deviations
- Intentionally approved temporary departures from a procedure (e.g., approved extension of hold time)
- Require prior risk assessment and QA approval
- Unplanned (Unintentional) Deviations
- Unexpected events or errors (e.g., temperature excursion, line clearance error, missed sampling)
- Based on Impact (definitions may vary by site):
- Critical – Potential impact on patient safety, product quality, or regulatory compliance
- Major – Significant impact on process or documentation, but controlled
- Minor – Low-risk events with no impact on product quality
Deviation Lifecycle
A robust deviation system typically follows these steps:
- Detection & Immediate Action
- Identify the event and take immediate measures to contain risk (e.g., quarantine batch, stop process).
- Recording & Initial Assessment
- Log the deviation in the quality system within defined timelines.
- Perform preliminary assessment of impact on product, patient, and compliance.
- Investigation & Root Cause Analysis
- Use tools such as 5-Why, Ishikawa, FMEA to identify true root cause(s).
- Review related batches, equipment, records, and historical trends.
- CAPA (Corrective and Preventive Actions)
- Define corrective actions to address the specific event.
- Define preventive actions to avoid recurrence (SOP revision, training, engineering changes, automation, etc.).
- QA Review & Approval
- QA evaluates the investigation, justifications, and CAPA effectiveness.
- Decide the disposition of impacted batch(es) – release, rework, or rejection.
- Effectiveness Check & Closure
- Verify that CAPAs have been implemented and are effective.
- Formally close the deviation within defined timelines.
Importance of a Strong Deviation Management System
- Demonstrates a culture of transparency and quality
- Provides data for trend analysis and continuous improvement
- Reduces recurrence of errors and unplanned events
- Supports regulatory inspections by providing clear, traceable justifications
A well-designed deviation process turns mistakes and unexpected events into learning opportunities, strengthening the overall pharmaceutical quality system.