Standard Operating Procedure for Adverse Reaction Reporting for Aerosols
1) Purpose
The purpose of this SOP is to establish procedures for the timely and accurate reporting of adverse reactions associated with aerosol products. This ensures compliance with regulatory requirements and supports ongoing product safety monitoring and risk management.
2) Scope
This SOP applies to the reporting of adverse reactions related to aerosol products marketed by [Company Name], including adverse events reported by healthcare providers, consumers, and clinical trial participants.
3) Responsibilities
Adverse Event Manager: Oversee adverse reaction reporting activities and ensure adherence to regulatory timelines and requirements.
Quality Assurance (QA) Team: Review and assess adverse event reports for completeness, accuracy, and regulatory compliance.
Medical Affairs: Provide medical assessment and support for adverse reaction evaluations and reporting.
Regulatory Affairs: Ensure timely reporting of adverse reactions to regulatory authorities as per regulatory obligations.
4) Procedure
4.1 Adverse Reaction Identification:
4.1.1 Establish methods for receiving and identifying potential adverse reactions associated with aerosol products.
4.1.2 Monitor adverse event reports from healthcare professionals, consumers, clinical trials, and post-marketing surveillance.
4.1.3 Classify adverse reactions based on severity, expectedness, and potential causal relationship to the aerosol product.
4.2 Adverse Event Documentation:
4.2.1 Document all reported adverse reactions in a standardized format, including patient demographics, medical history, and event details.
4.2.2 Ensure completeness and accuracy of adverse event data, including timelines and clinical outcomes.
4.2.3 Maintain confidentiality and compliance with patient privacy regulations during adverse event documentation.
4.3 Evaluation and Medical Assessment:
4.3.1 Evaluate reported adverse reactions clinically and medically to assess potential causal relationships with the aerosol product.
4.3.2 Consult medical experts or advisory boards as needed for complex or serious adverse reactions.
4.3.3 Document medical assessments and conclusions regarding the relationship between the aerosol product and adverse reactions.
4.4 Reporting to Regulatory Authorities:
4.4.1 Prepare and submit adverse event reports to regulatory authorities within specified timelines and formats (e.g., CIOMS form, MedWatch form).
4.4.2 Include all relevant information, such as patient demographics, adverse event description, medical assessment, and outcome.
4.4.3 Follow up with additional information or updates as requested by regulatory authorities.
4.5 Follow-Up and Safety Signal Detection:
4.5.1 Conduct follow-up investigations for reported adverse reactions to gather additional information and clarify clinical outcomes.
4.5.2 Monitor safety signals and trends in adverse reaction reporting to identify potential safety concerns or emerging risks.
4.5.3 Implement risk mitigation strategies or regulatory actions based on safety signal findings and regulatory requirements.
4.6 Documentation and Record Keeping:
4.6.1 Maintain comprehensive records of adverse reaction reports, including initial reports, follow-up investigations, and regulatory submissions.
4.6.2 Archive adverse reaction documentation in a secure and accessible manner for regulatory inspections and audits.
4.6.3 Update adverse reaction reporting procedures and documentation based on regulatory changes and internal review processes.
5) Abbreviations, if any
SOP: Standard Operating Procedure
CIOMS: Council for International Organizations of Medical Sciences
MedWatch: FDA’s Safety Information and Adverse Event Reporting Program
6) Documents, if any
Adverse Event Reports
Medical Assessment Records
Regulatory Submission Forms (CIOMS, MedWatch)
Follow-Up Investigation Reports
Safety Signal Detection Reports
7) Reference, if any
FDA Guidance for Industry: E2B(R3) Electronic Transmission of Individual Case Safety Reports
ICH E2E: Pharmacovigilance Planning
EMA Guideline on Good Pharmacovigilance Practices (GVP)
8) SOP Version
Version 1.0
