Standard Operating Procedure for Post-Market Surveillance for Creams
1) Purpose
The purpose of this SOP is to establish procedures for conducting post-market surveillance (PMS) activities for creams. This includes monitoring the safety and performance of marketed creams, collecting and analyzing relevant data, and taking appropriate actions to ensure continued product safety and efficacy.
2) Scope
This SOP applies to the Pharmacovigilance Department and all personnel involved in post-market surveillance activities for creams. It covers the monitoring of adverse events, product complaints, quality issues, and other relevant data related to the safety and efficacy of creams post-launch.
3) Responsibilities
The Pharmacovigilance Manager is responsible for overseeing and coordinating post-market surveillance activities. The Pharmacovigilance Team and Quality Assurance (QA) team are responsible for executing and ensuring compliance with this SOP.
4) Procedure
4.1 Signal Detection
4.1.1 Monitor and collect adverse events (AEs) and other safety signals associated with creams through spontaneous reports, literature review, and regulatory databases.
4.1.2 Conduct signal detection activities to identify potential safety concerns or emerging issues.
4.1.3 Document all identified signals and prioritize them based on severity and potential impact.
4.2 Data Collection and Analysis
4.2.1 Collect and analyze post-market data related to creams, including but not limited to:
- Adverse events (AEs)
- Product complaints
- Quality defects
- Medical inquiries
- Literature review findings
4.2.2 Perform trending and analysis of collected data to detect patterns or trends that may indicate potential safety or quality issues.
4.3 Risk Assessment
4.3.1 Assess identified signals and data trends to evaluate the potential risks associated with creams.
4.3.2 Determine the need for further investigation or action based on risk assessment outcomes.
4.3.3 Classify risks according to severity and likelihood of occurrence.
4.4 Reporting and Communication
4.4.1 Prepare periodic PMS reports summarizing findings, trends, and actions taken.
4.4.2 Communicate findings and recommendations to relevant stakeholders, including Regulatory Affairs, Medical Affairs, and Product Development teams.
4.4.3 Submit required reports to regulatory authorities in accordance with regulatory requirements.
4.5 Corrective and Preventive Actions (CAPA)
4.5.1 Initiate CAPA plans in response to identified risks or issues, including corrective actions to address current concerns and preventive actions to mitigate future risks.
4.5.2 Monitor and track the implementation of CAPA plans to ensure effectiveness and closure.
4.5.3 Document all CAPA activities and outcomes.
4.6 Documentation and Records
4.6.1 Maintain comprehensive documentation of all PMS activities, including data collection, analysis, risk assessments, reports, and CAPA actions.
4.6.2 Ensure that all PMS records are retained according to the company’s document retention policy.
5) Abbreviations, if any
SOP: Standard Operating Procedure
PMS: Post-Market Surveillance
AEs: Adverse Events
QA: Quality Assurance
6) Documents, if any
PMS Reports
Risk Assessment Reports
CAPA Plans and Reports
Regulatory Submissions
7) Reference, if any
ICH E2E: Pharmacovigilance Planning
EMA Guideline on Good Pharmacovigilance Practices (GVP)
8) SOP Version
Version 1.0