OBJECTIVE:

• To define the procedure for initiation, recording, investigation, evaluation, approval, trending, and closure of deviations, and for handling of rejections and destruction of materials and products, in compliance with regulatory requirements.

SCOPE:

• All deviations related to documented systems, procedures, RM/PM/FP specifications, analytical methods, and equipment. Rejection and destruction of raw materials, intermediates, packaging materials, and finished products.

RESPONSIBILITIES:

• Quality Assurance (QA) Department:
  • • Responsible for overseeing the deviation management process.
    • To initiate investigations.
    • To access impact of Deviation,
    • To determine corrective and preventive actions (CAPA).
    • To ensure compliance with SOPs and regulatory requirements.

• Initiator departments:
  • Responsible for promptly reporting deviations,
  • To provide initial assessment, and part of investigation team with QA in investigations and implementation of corrective actions.

• Department Heads:
  • Responsible for supporting investigations,
  • To provide resources,
  • To ensure implementation CAPAs within defined timelines.

• Cross functional teams:
  • To Involve in reviewing significant deviations.
  • To work on the tasks assigned during investigation of deviations and implementation of CAPA.

DEFINATIONS:

• Deviation: Any departure from an approved instruction, procedure, specification, analytical method, or standard practice.

• Planned Deviation: A deviation that is pre-approved before execution because it is unavoidable under specific circumstances. Examples include the use of an alternate material supplier during an approved changeover, or temporary operation outside normal conditions during preventive maintenance.

• Unplanned Deviation: A deviation that occurs unexpectedly and without prior approval, such as equipment malfunction, human error, or unintentional process drift.

• Minor Deviation: No direct impact on quality, safety, or efficacy.
• Major Deviation: Potential to impact quality attributes or processes, but unlikely to pose risk to patients.
• Critical Deviation: High probability of impacting product quality, patient safety, or regulatory compliance; requires immediate escalation to QA Head.
• Quality Risk Management (QRM): A systematic process for assessment, control, communication, and review of risks to product quality throughout its life cycle.

PROCEDURE:

Identification and Reporting of Deviations:

• Any person who identifies a deviation shall immediately inform their supervisor or department head.
• The department head or designee shall then notify the Quality Assurance (QA) department.
• The QA department shall issue a Deviation Report with a unique deviation number in the format DF/YYYY/XXX (for example, DF/2025/001).
  • DF stands for Deviation form
  • YYYY stands for the year
  • XXX stands for Serial number
• The initiator, in coordination with QA, shall then complete the issued Deviation form by recording the type of deviation (planned or unplanned), the nature of the deviation, the date and time of occurrence, any immediate corrective actions taken, and the suspected impact.
• The QA department shall record the deviation number and relevant details in the Deviation Log  to ensure traceability and control.
• Classification of Deviations:
  • Deviations shall be classified in two steps:
    • By type – Planned or Unplanned.
    • By impact – Minor, Major, or Critical.
• Planned deviations must be approved in advance by QA and management, with a documented risk assessment and a clear time-bound justification.
• Unplanned deviations must be reported immediately, investigated by investigated by initiator department along with QA designee, and subject to classification into minor, major, or critical based on impact assessment.

The escalation path shall be followed as described below:

• Minor and Major deviations shall be reviewed by the Designee QA and forwarded to the Head QA for approval.
• Critical deviations shall be reviewed by the Designee QA and escalated to the Head QA, and finally to senior management for authorization.

Impact Assessment:

• QA reviews the Deviation Form upon receipt to determine the classification (critical, major, minor) based on potential impact on product quality, safety, efficacy, or compliance.
• QA assesses the impact of the deviation on product quality, safety, efficacy, regulatory compliance, and business operations.
• QA may request additional information or clarification from operations personnel as needed to complete the impact assessment.

Investigation and Root Cause Analysis:

• The QA department shall initiate an investigation within two working days of the reporting of a deviation.
• The investigation shall include the gathering of evidence, review of documents, and interviews with relevant staff. Root cause analysis tools such as the 5-Why method, Fishbone diagram, or Failure Mode and Effects Analysis (FMEA) may be used.

Corrective and Preventive Actions (CAPA)

• Corrective actions shall be taken to address the immediate cause of the deviation, and preventive actions shall be designed to prevent recurrence.
• CAPA responsibilities, target dates, and methods for verifying effectiveness shall be documented in the deviation report. The effectiveness of CAPA shall be verified by QA prior to closure.

Timelines for Review and Closure:

• Critical deviations shall be reviewed within twenty-four hours of reporting and must be closed within thirty calendar days.
• Major deviations shall be reviewed within five working days and closed within thirty calendar days.
• Minor deviations shall be reviewed within ten working days and closed within thirty calendar days.
• Any extension of these timelines must be justified in writing and approved by QA management.

Trending and Integration into PQR:

• The QA department shall prepare Quarterly deviation trend reports.
• All deviations, shall be included in the trending process.
• Deviation data and CAPA trends shall be incorporated into the Product Quality Review and Quality Management Review in order to identify systemic issues and drive continuous improvement.

Documentation and Record Retention:

• The QA department shall maintain the Deviation Log to track all deviations.
• All deviation records shall be retained for a minimum of five years or as required by product registration.

Review and Closure:

• QA reviews implemented CAPA to verify effectiveness and closure of deviations.
• The Deviation Report is closed once all actions are completed, documented, and reviewed.

REFERENCES:

• EU GMP Part I (Ch. 1 & Ch. 8),
• Annex 20 (Quality Risk Management).
• WHO TRS

RECORDS:

REVISION HISTORY.