Learn how to write SOP for Handling Deviations. Ensure compliance, document deviations effectively, and implement corrective actions to maintain quality standard.
1. PURPOSE
To describes a standard procedure for identifying, documenting, investigating, and resolving deviations from standard operating procedures (SOPs), manufacturing processes, or quality standards in pharmaceutical operations, ensuring compliance with regulatory requirements and maintaining product quality.
2. SCOPE
This SOP is applicable to all employees involved in operations where deviations from established processes, procedures, or specifications may occur. This includes manufacturing, quality assurance, quality control, and support functions.
3. RESPONSIBILITIES
3.1 Initiator: Responsible for identifying and reporting deviations immediately.
3.2 Department Head/Manager: Responsible for initial evaluation and providing relevant details for investigation.
3.3 Quality Assurance (QA): Responsible for documenting deviations, coordinating investigations, approving corrective and preventive actions (CAPA), and ensuring compliance with regulatory standards.
3.4 Production/Operations Team: Responsible for implementing corrective actions and ensuring deviations are minimized.
4. ACCOUNTABILITY
Head of the Quality Assurance Department
5. ASSOCIATED DOCUMENTS / REFERENCES
5.1 SOP for Corrective and Preventive Actions (CAPA)
6. PRECAUTIONS
6.1 Wear the appropriate safety equipment & garments for each area audited.
7. PROCEDURE
7.1Identify any deviation from approved procedures or processes during operations.
7.2 Report the deviation immediately to the supervisor or department head.
7.3 Record the deviation details in the Deviation Logbook following the attached format in Annex-3
7.4The department head evaluates the deviation to determine its category (minor, major, or critical).
7.5 Notify the QA department for all deviations, irrespective of severity.
7.6 Collect the Deviation Report Form (DRF) from Quality Assurance Department following the attached form format in Annex-2
7.7 Quality Assurance personnel assign an investigation team and initiate an investigation to determine the root cause.
7.8 Conduct a Root Cause Analysis (RCA) using tools like the 5 Whys or Fishbone Diagram.
7.9 Identify contributing factors and determine whether the deviation is recurring.
7.10 Assess the impact of the deviation on product quality, safety, and regulatory compliance.
7.11 Determine if affected products require additional testing, rework, or disposal.
7.12 Develop Corrective and Preventive Actions (CAPA) to address the root cause and prevent recurrence.
7.13 Ensure CAPA includes timelines, responsibilities, and specific actions.
7.14 Obtain approval from Quality Assurance for the Corrective and Preventive Actions (CAPA) plan.
7.15 Implement corrective actions as per the approved Corrective and Preventive Actions (CAPA) plan.
7.16 Quality Assurance personnel monitor the implementation to ensure effectiveness.
7.17 Quality Assurance Head reviews and verifies the completion of Corrective and Preventive Actions (CAPA).
7.18 Document the closure in the Deviation Report.
7.19 Update the Deviation Logbook.
7.20 Quality Assurance conducts periodic trend analysis of deviations to identify recurring issues.
8. DEFINITIONS AND ABBREVIATIONS
8.1Deviation: A deviation refers to a departure from an approved procedure, standard, or specification in pharmaceutical operations. It can occur during manufacturing, quality control, or other processes, potentially impacting product quality, safety, or compliance. For example, using a reagent past its expiry date during analysis is a deviation.
8.2 Minor Deviation: Minor deviation has no significant impact on product quality, safety, or efficacy and does not compromise regulatory compliance. It is usually an isolated incident. Examples include slight delays in equipment cleaning, minor temperature fluctuations within acceptable limits, or documentation errors that don’t affect critical data.
8.3 Minor Deviation: Major deviation has the potential to impact product quality, safety, efficacy, or regulatory compliance. It requires investigation and corrective actions to prevent recurrence. For Examples, equipment malfunctions during production, missing key calibration records, or deviations from standard procedures that could impact intermediate product quality.
8.4 Critical deviation: Critical deviation poses a serious threat to product quality, patient safety, or regulatory compliance and may lead to product rejection or recall. Immediate investigation and containment measures are mandatory. For examples, cross-contamination of products during manufacturing due to failure of cleaning procedures, microbial contamination of sterile products, use of unqualified suppliers for critical raw materials, or release of products without completing essential quality tests.
8.5 CAPA: Corrective and Preventive Actions
8.6 RCA: Root Cause Analysis
8.7 SOP: Standard Operating Procedure
8.8 QA: Quality Assurance
9. ANNEXES
9.1 Annex-1: Deviation Flow Chart
9.2 Annex-2: Deviation Report Form (DRF)
9.3 Annex-1: Log Book for Deviation
10. Revision History
| Version | Date | Description of Change | Reviewed By | Approved By |
| 1.0 |
Abdus Sobhan Salim is professional experienced pharmacist in pharmaceuticals, author and founder of pharmabossbd.com, the Bangladeshi pharmaceutical blogger since 2019.
