1.0 OBJECTIVE:
1.1 To define the procedure for receiving, recording, documenting, and forwarding Adverse Events (AE) and Adverse Drug Reactions (ADR) reported from any source.
1.2 To ensure compliance with World Health Organization (WHO), European Union Good Pharmacovigilance Practices (EU-GVP), and local regulatory requirements.
1.3 To ensure all safety information is processed accurately, completely, and within required timelines.
2.0 SCOPE:
2.1 This SOP applies to all employees and third-party partners involved in AE/ADR reporting.
2.2 Covers safety information received from:
2.2.1 Healthcare professionals
2.2.2 Patients/consumers
2.2.3 Distributors, partners, representatives
2.2.4 Literature sources
2.2.5 Call centers
2.2.6 Emails, letters, telephone calls
2.2.7 Product Quality Complaints with AE (PQC with AE)
2.3 Applies to all marketed products of the company.
3.0 RESPONSIBILITIES:
3.1 All Employees / Field Force / Partners:
3.1.1 Must report any AE/ADR received from any source within 24 hours.
3.1.2 Must not modify or interpret the information received.
3.1.3 Must forward AE/ADR to the Pharmacovigilance (PV) department immediately.
3.2 Pharmacovigilance (PV) Department:
3.2.1 Receive AE/ADR reports and verify completeness.
3.2.2 Create the initial case record and assign case number.
3.2.3 Perform triage: serious vs non-serious.
3.2.4 Initiate follow-up with reporter if minimum criteria are incomplete.
3.2.5 Forward AE/ADR to safety database for processing.
3.2.6 Maintain AE/ADR logs, audit trails, and archival requirements.
3.3 Regulatory Affairs (RA):
3.3.1 Ensure updated safety reporting timelines are available for each country.
3.3.2 Support PV in timely regulatory submissions.
3.4 Quality Assurance (QA):
3.4.1 Ensure AE/ADR recording aligns with QMS requirements.
3.4.2 For Product Quality Complaint (PQC) + AE cases, coordinate with PV for evaluation, if needed.
4.0 DEFINATIONS:
4.1 Adverse Event (AE): Any untoward medical occurrence in a patient administered a medicinal product, not necessarily causally related.
4.2 Adverse Drug Reaction (ADR): A noxious and unintended response to a medicinal product.
4.3 Individual Case Safety Report (ICSR): A report documenting AE/ADR for one individual patient.
5.0 PROCEDURE:
5.1 AE/ADR Intake – Identification of a Safety Case:
5.1.1 A safety case is created when the minimum required information is present:
5.1.1.1 Patient (age/initials/gender acceptable)
5.1.1.2 Reporter (doctor, patient, nurse, distributor, etc.)
5.1.1.3 Suspect product
5.1.1.4 AE/ADR description
5.1.2 If any element is missing, follow-up must be initiated immediately.
5.2 Sources of AE/ADR:
5.2.1 AE/ADR sources shall be from the list below,
5.2.1.1 Healthcare professionals
5.2.1.2 Patients or consumers
5.2.1.3 Distributors, call centers
5.2.1.4 Literature articles
5.2.1.5 Digital media (if monitored)
5.2.1.6 Product complaints (PQC) connected with AE
5.2.1.7 Internal employees during their duties
5.3 Initial Recording of AE/ADR:
5.3.1 AE/ADR shall be recorded exact as reported.
5.3.2 No editing, medical judgement, or assumptions shall be added.
5.3.3 Reporter details shall be captured accurately.
5.3.4 AE/ADR shall be recorded on the approved AE Intake Form.
5.4 Timelines for Reporting to PV:
5.4.1 All AE/ADR shall be forwarded to PV within 24 hours of awareness.
5.4.2 For partners, timelines defined in Safety Data Exchange Agreement (SDEA) must be followed.
5.5 Verification & Case Creation:
5.5.1 Pharmacovigilance shall verify completeness of minimum criteria.
5.5.2 A unique case ID is assigned.
5.5.3 AE/ADR is categorized as:
5.5.3.1 Serious
5.5.3.2 Non-serious
5.5.4 Follow-up questions are prepared if required.
5.6 Handling Serious AE/ADR:
5.6.1 Serious cases shall include:
5.6.1.1 Death
5.6.1.2 Life-threatening event
5.6.1.3 Hospitalization
5.6.1.4 Disability
5.6.1.5 Congenital anomaly
5.6.2 Serious cases shall be prioritized for immediate processing.
5.6.3 Serious AE/ADR shall be sent for database entry and reporting within regulatory timelines.
5.7 Follow-up Process
5.7.1 If minimum criteria are incomplete, immediate follow-up is mandatory.
5.7.2 Preferred channels shall use for follow-up:
5.7.2.1 Email
5.7.2.2 Phone
5.7.2.3 Written letter
5.7.3 All follow-up attempts shall be documented.
5.8 Documentation & Logging:
5.8.1 Pharmacovigilance dept shall maintain an AE/ADR Intake Log including:
5.8.1.1 Case number
5.8.1.2 Date received
5.8.1.3 Reporter details
5.8.1.4 Product
5.8.1.5 Case seriousness
5.8.2 Exact notes shall be attached to case file.
5.8.3 Product Quality Complaints with AE (PQC + AE):
5.8.3.1 PQC + AE cases must be treated as safety cases.
5.8.3.2 Case must be shared with Quality Assurance dept for quality investigation.
5.8.3.3 Safety assessment shall be performed by PV.
5.9 Escalation:
5.9.1 Any AE related to:
5.9.1.1 Product defect
5.9.1.2 Counterfeit suspicion
5.9.2 Cluster events shall be escalated to Qualified Person for Pharmacovigilance immediately.
5.9.3 Significant or unusual events may require notification to regulatory authorities.
5.10 Record Retention:
5.10.1 All AE/ADR documents must be retained for minimum 5 years.
5.10.2 Electronic and paper records must be protected from alteration.
5.11 Training:
5.11.1 All employees must be trained on AE/ADR identification and reporting.
5.11.2 Annual refresher training shall be conducted.
5.11.3 Training records must be maintained as per Quality Management System (QMS) Training SOP.
5.12 Deviations:
5.12.1 Any deviation from this SOP must follow the Deviation and CAPA SOP.
5.12.2 QPPV must be notified for deviations impacting safety reporting, if the deviation related to PV.
5.13 Numbering System for AE/ADR:
5.13.1 Standard Numbering Pattern for AE / ADR Cases shall follow as below,
5.13.1.1 AE/YY/NNN and ADR/YY/NNN
5.13.1.2 AE/YY/NNN = Adverse Event case
5.13.1.3 ADR/YY/NNN = Adverse Drug Reaction case (after assessment)
5.13.2 Where:
5.13.2.1 AE / ADR = Type of case
5.13.2.2 YY = Last two digits of the year (e.g. 25 for 2025)
5.13.2.3 NNN = Sequential running number for that year (001, 002, 003…)
5.13.3 Examples:
5.13.3.1 AE/25/001 = 1st AE reported in 2025
5.13.3.2 ADR/25/007 = 7th ADR (causality established) in 2025
5.13.4 We shall use AE numbering patterned at intake and after medical review confirms ADR number of same sequence
6.0 REFERENCES:
6.1 WHO Technical Report Series (TRS) – PV guidance
6.2 EU Good Pharmacovigilance Practices (GVP)
6.3 Company QMS SOPs (Document Control, Training, Audit, Risk Management, Deviation & CAPA)
7.0 RECORDS:
Sr No. Title Document No.
1 AE / ADR Intake form F/PV004/001 – 00
2 Minimum Information Checklist F/PV004/002 – 00
3 Follow up questionnaire F/PV004/003 – 00
8.0 REVISION HISTORY.
Amendment Date: Update Summary Version No.
NA New SOP 01