Standard Operating Procedure for Post-Market Surveillance for Transdermal Patches
1) Purpose
To establish procedures for monitoring the safety and performance of transdermal patches after market release, ensuring timely detection, reporting, and management of adverse events and product quality issues.
2) Scope
This SOP applies to the post-market surveillance team responsible for monitoring transdermal patches, including pharmacovigilance, quality assurance (QA), regulatory affairs, and medical affairs personnel.
3) Responsibilities
3.1 Pharmacovigilance: Monitor and report adverse events related to transdermal patches.
3.2 QA/QC: Assess product complaints and non-conformities to determine if corrective actions are needed.
3.3 Regulatory Affairs: Ensure compliance with regulatory reporting requirements for adverse events and product issues.
3.4 Medical Affairs: Evaluate medical inquiries and provide expertise on product safety and efficacy.
3.5 Post-Market Surveillance Manager: Oversee the overall post-market surveillance activities and ensure timely reporting and escalation of issues.
4) Procedure
4.1 Adverse Event Monitoring:
4.1.1 Establish processes for receiving, documenting, and evaluating adverse event reports associated with transdermal patches.
4.1.2 Classify adverse events according to severity and expectedness.
4.2 Product Quality Monitoring:
4.2.1 Monitor and investigate product complaints and non-conformities related to transdermal patches.
4.2.2 Conduct root cause analysis for identified quality issues and implement corrective and preventive actions (CAPA).
4.3 Reporting and Documentation:
4.3.1 Document all adverse events, product complaints, and investigations in a structured manner.
4.3.2 Prepare and submit timely reports to regulatory authorities as per regulatory requirements.
4.4 Review and Evaluation:
4.4.1 Periodically review and evaluate post-market surveillance data to identify trends or signals that may indicate potential safety or quality issues.
4.4.2 Conduct risk assessments and determine if any updates to risk management plans or product labeling are necessary.
4.5 Continuous Improvement:
4.5.1 Implement measures to improve post-market surveillance processes based on findings from reviews and evaluations.
4.5.2 Provide training to relevant personnel on post-market surveillance procedures and regulatory requirements.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
QC: Quality Control
CAPA: Corrective and Preventive Actions
6) Documents, if any
Adverse Event Reports
Product Complaint Records
Regulatory Submission Documents
7) Reference, if any
ICH E2E: Pharmacovigilance Planning
EU Pharmacovigilance Legislation
FDA Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines
8) SOP Version
Version 1.0
