Standard Operating Procedure for Adverse Reaction Reporting for Creams
1) Purpose
The purpose of this SOP is to establish procedures for reporting adverse reactions (ARs) associated with creams. This ensures timely and accurate reporting of ARs to regulatory authorities, facilitating continuous monitoring of product safety and compliance with regulatory requirements.
2) Scope
This SOP applies to the Pharmacovigilance Department and all personnel involved in the reporting and management of adverse reactions related to creams. It covers the identification, documentation, assessment, and reporting of adverse reactions occurring during clinical trials, post-marketing surveillance, or other monitoring activities.
3) Responsibilities
The Pharmacovigilance Manager is responsible for overseeing and coordinating adverse reaction reporting activities. The Pharmacovigilance Team and Quality Assurance (QA) team are responsible for executing and ensuring compliance with this SOP.
4) Procedure
4.1 Identification and Documentation of Adverse Reactions
4.1.1 Healthcare professionals, consumers, or other stakeholders report adverse reactions associated with creams to the Pharmacovigilance Department.
4.1.2 Collect all relevant information regarding the adverse reaction, including:
- Patient demographics
- Description of the adverse event
- Concomitant medications
- Severity and outcome of the adverse reaction
4.2 Assessment of Adverse Reactions
4.2.1 Review and assess the reported adverse reactions for seriousness, expectedness, and causality related to the use of creams.
4.2.2 Classify adverse
4.2.3 Conduct follow-up inquiries or investigations as needed to gather additional information.
4.3 Reporting to Regulatory Authorities
4.3.1 Prepare and submit expedited reports of serious and unexpected adverse reactions to regulatory authorities within specified timelines.
4.3.2 Compile periodic safety update reports (PSURs) summarizing all adverse reaction data for regulatory submissions.
4.3.3 Maintain ongoing communication with regulatory authorities regarding adverse reaction reports and follow-up actions.
4.4 Communication and Documentation
4.4.1 Communicate adverse reaction information to relevant stakeholders, including Regulatory Affairs, Medical Affairs, and Product Development teams.
4.4.2 Document all adverse reaction reports, assessments, and communications in the pharmacovigilance database.
4.4.3 Ensure confidentiality and compliance with data protection regulations during adverse reaction reporting.
4.5 Follow-up and CAPA Actions
4.5.1 Implement corrective and preventive actions (CAPA) based on findings from adverse reaction reports and assessments.
4.5.2 Monitor the effectiveness of CAPA actions and update risk management plans as necessary.
4.5.3 Document all CAPA activities and maintain records of follow-up actions related to adverse reaction reporting.
4.6 Training and Awareness
4.6.1 Provide training to relevant personnel on the identification, documentation, and reporting of adverse reactions.
4.6.2 Promote awareness of adverse reaction reporting requirements and procedures among healthcare professionals and consumers.
5) Abbreviations, if any
SOP: Standard Operating Procedure
AR: Adverse Reaction
PSUR: Periodic Safety Update Report
QA: Quality Assurance
6) Documents, if any
Adverse Reaction Reports
Periodic Safety Update Reports (PSURs)
Follow-up and CAPA Reports
Regulatory Submissions
7) Reference, if any
ICH E2D: Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting
EMA Guideline on Good Pharmacovigilance Practices (GVP)
8) SOP Version
Version 1.0