Deviation Handling Procedures

1) Purpose

The purpose of this SOP is to establish a standardized procedure for identifying, documenting, investigating, and resolving deviations from standard procedures in the pharmaceutical manufacturing process.

2) Scope

This SOP applies to all deviations from standard procedures within the pharmaceutical manufacturing facility.

3) Responsibilities

– Production and QC personnel are responsible for identifying and documenting deviations.
– QA personnel are responsible for investigating deviations, determining their impact, and ensuring appropriate corrective actions are taken.

4) Procedure

1. Identifying Deviations
1.1. Identify deviations from standard procedures during routine operations, audits, or inspections.
1.2. Examples of deviations include out-of-specification results, equipment malfunctions, and procedural errors.
2. Documenting Deviations
2.1. Document each deviation on a deviation report form.
2.2. Include details such as the nature of the deviation, date and time of occurrence, affected batch or process, and personnel involved.
2.3. Assign a unique deviation reference number for tracking purposes.
3. Initial Assessment
3.1. Conduct an initial assessment to determine the potential impact of the deviation on product quality and safety.
3.2. If the deviation has a significant impact, immediately notify the QA department and halt affected operations if necessary.
4. Investigation
4.1. QA personnel should lead a thorough investigation to determine the root cause of the deviation.
4.2. Review relevant records, conduct interviews with involved personnel, and perform any necessary tests.
4.3. Document all findings and observations during the investigation.
5. Root Cause Analysis
5.1. Identify the root cause of the deviation using appropriate analysis tools, such as fishbone diagrams, 5 Whys, or failure mode and effects analysis (FMEA).
6. Corrective and Preventive Actions (CAPA)
6.1. Develop a CAPA plan to address the root cause of the deviation.
6.2. Implement corrective actions to resolve the immediate issue.
6.3. Implement preventive actions to prevent recurrence of the deviation.
6.4. Document all actions taken in the CAPA report.
7. Documentation
7.1. Record all deviation handling activities in the deviation report form and CAPA report.
7.2. Include details of the investigation, root cause analysis, and CAPA.
7.3. Sign and date all entries in the reports.
8. Review and Approval
8.1. Submit the completed deviation report and CAPA report to the QA department for review.
8.2. QA will review and approve the results, ensuring that all necessary actions have been taken and that the deviation has been properly resolved.

5) Abbreviations, if any

– QC: Quality Control
– QA: Quality Assurance
– CAPA: Corrective and Preventive Actions

6) Documents, if any

– Deviation Report Form
– CAPA Report Form

7) Reference, if any

– FDA 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
– ICH Q10 – Pharmaceutical Quality System

8) SOP Version

Version 1.0