Standard Operating Procedure for Post-Market Surveillance for Aerosols
1) Purpose
The purpose of this SOP is to establish procedures for monitoring the safety and performance of aerosol products in the market after regulatory approval. This includes the systematic collection, analysis, and reporting of post-market surveillance data to ensure continuous product safety and efficacy.
2) Scope
This SOP applies to post-market surveillance activities for aerosol products marketed by [Company Name], including adverse event reporting, complaint handling, periodic safety updates, and risk management.
3) Responsibilities
Post-Market Surveillance Manager: Oversee post-market surveillance activities and ensure compliance with regulatory requirements.
Quality Assurance (QA) Team: Review and assess adverse event reports, complaint investigations, and risk management activities.
Medical Affairs: Provide medical oversight and support for the evaluation of safety-related data.
Regulatory Affairs: Ensure timely reporting of safety-related information to regulatory authorities as per regulatory obligations.
4) Procedure
4.1 Adverse Event Reporting:
4.1.1 Establish procedures for receiving, documenting, and evaluating adverse event reports related to aerosol products.
4.1.2 Classify adverse events based on severity, expectedness, and potential causal relationship to the product.
4.1.3 Report serious adverse events to regulatory authorities within specified timelines.
4.2 Complaint Handling:
4.2.1 Receive and document complaints related to aerosol products from consumers, healthcare providers, and distributors.
4.2.2 Investigate complaints thoroughly to determine root causes and corrective actions.
4.2.3 Maintain records of complaint investigations and communicate findings to relevant stakeholders.
4.3 Periodic Safety Updates:
4.3.1 Compile periodic safety update reports (PSURs) or periodic benefit-risk evaluation reports (PBRERs) for aerosol products.
4.3.2 Review and analyze safety data from post-market surveillance, clinical trials, literature, and other sources.
4.3.3 Assess the overall benefit-risk profile of aerosol products and recommend risk minimization measures if necessary.
4.4 Risk Management:
4.4.1 Implement a risk management plan (RMP) for aerosol products, including risk identification, assessment, and mitigation strategies.
4.4.2 Conduct ongoing risk assessments based on emerging safety data and changes in product use patterns.
4.4.3 Update the RMP as needed and communicate changes to relevant stakeholders.
4.5 Signal Detection and Evaluation:
4.5.1 Monitor and analyze safety signals identified through post-market surveillance data, including trends in adverse events or unexpected patterns.
4.5.2 Evaluate potential signals for significance and take appropriate actions, such as further investigation or communication.
4.5.3 Document signal detection activities and outcomes for regulatory reporting and internal review.
4.6 Communication and Reporting:
4.6.1 Communicate safety-related information to internal stakeholders, including management, medical affairs, and regulatory affairs.
4.6.2 Prepare and submit periodic safety reports, including PSURs, PBRERs, and other regulatory submissions as required.
4.6.3 Ensure compliance with regulatory reporting obligations for adverse events, product recalls, and safety updates.
5) Abbreviations, if any
SOP: Standard Operating Procedure
PSUR: Periodic Safety Update Report
PBRER: Periodic Benefit-Risk Evaluation Report
RMP: Risk Management Plan
6) Documents, if any
Adverse Event Reports
Complaint Investigation Records
Periodic Safety Update Reports (PSURs)
Risk Management Plan (RMP)
Signal Detection Reports
7) Reference, if any
FDA Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products
EMA Guideline on Good Pharmacovigilance Practices (GVP)
ICH E2E: Pharmacovigilance Planning
8) SOP Version
Version 1.0
