Standard Operating Procedure for Adverse Reaction Reporting for Gels
1) Purpose
The purpose of this SOP is to establish procedures for the identification, documentation, reporting, and management of adverse reactions associated with the use of gels, ensuring compliance with regulatory requirements and timely communication of safety information.
2) Scope
This SOP applies to all personnel involved in the pharmaceutical manufacturing facility’s Pharmacovigilance and Safety department, including Pharmacovigilance Officers, Medical Affairs, Regulatory Affairs, Quality Assurance (QA), and other relevant personnel responsible for adverse reaction reporting.
3) Responsibilities
Pharmacovigilance Officers: Receive, assess, and report adverse reactions associated with gels to regulatory authorities.
Medical Affairs: Provide medical expertise and support in the assessment and management of adverse reactions.
Regulatory Affairs: Ensure compliance with regulatory requirements related to adverse reaction reporting.
Quality Assurance (QA): Oversee adherence to SOPs and regulatory guidelines throughout adverse reaction reporting processes.
4) Procedure
4.1 Identification and Documentation
4.1.1 Receive and document reports of adverse reactions associated with the use of gels from healthcare professionals, patients, clinical trials, and other sources.
4.1.2 Gather comprehensive information on the adverse event, including patient demographics, medical history, concomitant medications, and details of the gel product used.
4.2 Assessment and Causality Determination
4.2.1 Assess the severity and seriousness of adverse reactions based on established criteria and medical judgment.
4.2.2 Determine the likelihood of the adverse reaction being related to the use of the gel product (causality assessment).
4.3 Reporting to Regulatory Authorities
4.3.1 Prepare and submit Individual Case Safety Reports (ICSRs) to regulatory authorities in accordance with applicable regulations and timelines.
4.3.2 Report serious and unexpected adverse reactions promptly, following regulatory reporting requirements.
4.4 Follow-Up and Communication
4.4.1 Conduct follow-up activities to obtain additional information on reported adverse reactions as necessary.
4.4.2 Communicate safety updates and findings to internal stakeholders, regulatory authorities, healthcare professionals, and patients as appropriate.
4.5 Signal Detection and Risk Management
4.5.1 Participate in signal detection activities to identify potential safety signals or trends associated with the use of gels.
4.5.2 Implement risk minimization measures and corrective actions based on adverse reaction data and safety assessments.
4.6 Documentation and Archiving
4.6.1 Maintain accurate and up-to-date records of all adverse reaction reports, assessments, and communications.
4.6.2 Archive adverse reaction reports and related documentation in accordance with company procedures and regulatory requirements.
5) Abbreviations, if any
SOP: Standard Operating Procedure
ICSR: Individual Case Safety Report
6) Documents, if any
– Individual Case Safety Reports (ICSRs)
– Adverse Event Reporting Forms
– Correspondence with Regulatory Authorities
– Risk Assessments and Causality Assessments
7) Reference, if any
– FDA Guidance for Industry: Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements
– ICH Guidelines for Pharmacovigilance
– Company-specific adverse reaction reporting procedures and guidelines
8) SOP Version
Version 1.0