Standard Operating Procedure for Post-Market Surveillance for Gels
1) Purpose
The purpose of this SOP is to establish procedures for conducting post-market surveillance (PMS) activities for gels to monitor their safety, efficacy, and performance in real-world use, and to ensure compliance with regulatory requirements.
2) Scope
This SOP applies to all personnel involved in the pharmaceutical manufacturing facility’s Post-Market Surveillance department, including Regulatory Affairs, Pharmacovigilance, Quality Assurance (QA), Clinical Research, and other relevant personnel responsible for PMS activities.
3) Responsibilities
Regulatory Affairs: Ensure compliance with regulatory requirements related to PMS activities for gels.
Pharmacovigilance: Monitor and evaluate adverse events and safety data related to gels in the post-market phase.
Quality Assurance (QA): Oversee compliance with SOPs and regulatory requirements throughout PMS activities.
Clinical Research: Provide clinical data and insights to support PMS activities and safety assessments.
Medical Affairs: Communicate PMS findings and safety updates to healthcare professionals and patients as necessary.
4) Procedure
4.1 Post-Market Surveillance Plan
4.1.1 Develop a PMS Plan outlining objectives, methodologies, timelines, and responsibilities for conducting PMS activities for gels.
4.1.2 Define criteria and thresholds for reporting adverse events, quality issues, and safety concerns.
4.2 Data Collection and Analysis
4.2.1 Collect and analyze real-world data from various sources, including spontaneous reports, literature reviews, clinical studies, and customer feedback.
4.2.2 Evaluate adverse events, product complaints, and other safety-related data to assess the overall safety profile of gels.
4.3 Signal Detection and Risk Assessment
4.3.1 Perform signal detection activities to identify potential safety signals or emerging risks associated with the use of gels.
4.3.2 Conduct risk assessments and benefit-risk evaluations based on collected data and safety findings.
4.4 Reporting and Communication
4.4.1 Prepare periodic safety update reports (PSURs) and other regulatory reports as required by regulatory authorities.
4.4.2 Communicate safety findings, updates, and recommendations to internal stakeholders, regulatory authorities, healthcare professionals, and patients as appropriate.
4.5 CAPA and Continuous Improvement
4.5.1 Implement corrective and preventive actions (CAPA) based on PMS findings to mitigate risks and improve product safety.
4.5.2 Continuously monitor and update PMS activities based on new data, regulatory changes, and emerging safety concerns.
4.6 Documentation and Archiving
4.6.1 Maintain comprehensive documentation of all PMS activities, including reports, data analyses, CAPA actions, and communication records.
4.6.2 Archive PMS documents in accordance with company procedures and regulatory requirements.
5) Abbreviations, if any
SOP: Standard Operating Procedure
PMS: Post-Market Surveillance
PSUR: Periodic Safety Update Report
CAPA: Corrective and Preventive Actions
6) Documents, if any
– Post-Market Surveillance Plan
– Periodic Safety Update Reports (PSURs)
– Adverse Event Reports
– Risk Assessments and Benefit-Risk Evaluations
7) Reference, if any
– FDA Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
– ICH Guidelines for Pharmacovigilance
– Company-specific PMS procedures and guidelines
8) SOP Version
Version 1.0