Standard Operating Procedure for Deviation Handling in Transdermal Patches Production

1) Purpose

The purpose of this SOP is to establish a standardized procedure for identifying, documenting, investigating, and resolving deviations from established processes and procedures in the production of transdermal patches to ensure product quality and regulatory compliance.

2) Scope

This SOP applies to all personnel involved in the production, quality control, and quality assurance of transdermal patches, as well as any other departments that may encounter deviations during their activities.

3) Responsibilities

The Quality Assurance (QA) Department is responsible for overseeing the deviation handling process. All personnel are responsible for identifying and reporting deviations and cooperating in the investigation and resolution process.

4) Procedure

4.1 Identification and Reporting of Deviations

• 4.1.1 Identify any deviation from established procedures, specifications, or standards during production or quality control activities.
• 4.1.2 Immediately report the deviation to the supervisor or QA Department using the Deviation Report Form.
• 4.1.3 Document the details of the deviation, including date, time, description of the deviation, and any immediate corrective actions taken, in the Deviation Report Form.

4.2 Initial Assessment

• 4.2.1 The QA Department conducts an initial assessment of the reported deviation to determine its potential impact on product quality, safety, and regulatory compliance.
• 4.2.2 Categorize the deviation based on its severity (e.g., minor, major, critical) and determine if immediate actions are required to mitigate any adverse effects.

4.3 Investigation

• 4.3.1 Assign a cross-functional team to investigate the deviation, including representatives from QA, Production, QC, and any other relevant departments.
• 4.3.2 Conduct a thorough investigation to determine the root cause of the deviation, including a review of batch records, equipment logs, and other relevant documents.
• 4.3.3 Document the investigation findings, including the identified root cause, in the Deviation Investigation Report.

4.4 Corrective and Preventive Actions (CAPA)

• 4.4.1 Based on the investigation findings, develop and implement corrective actions to address the immediate cause of the deviation.
• 4.4.2 Identify and implement preventive actions to eliminate the root cause and prevent recurrence of similar deviations.
• 4.4.3 Document all CAPA activities, including action plans, responsible personnel, and completion dates, in the Deviation Investigation Report.

4.5 Review and Approval

• 4.5.1 The QA Department reviews the completed Deviation Investigation Report, including CAPA activities, to ensure adequacy and completeness.
• 4.5.2 Obtain final approval from the QA Manager or designee before closing the deviation report.

4.6 Documentation and Trending

• 4.6.1 Maintain all deviation reports and related documentation in a centralized Deviation Log.
• 4.6.2 Conduct periodic reviews and trend analysis of deviations to identify patterns or areas for process improvement.
• 4.6.3 Implement process improvements based on trending analysis to enhance product quality and compliance.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance
QC: Quality Control
CAPA: Corrective and Preventive Actions

6) Documents, if any

Deviation Report Form
Deviation Investigation Report
Deviation Log
CAPA Documentation

7) Reference, if any

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

8) SOP Version

Version 1.0