SOPREFERENCE OUTLINE

Complaint Handling & Recall SOP

A procedure covering receipt, triage, investigation, and trending of product complaints, and the decision, classification, execution, and effectiveness check of a recall — including regulator notification. Aligned to 21 CFR 211.198, EU GMP Chapter 8, and the PQS expectations of ICH Q10.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

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REGULATIONS MAPPED
21 CFR 211.198EU GMP Chapter 8ICH Q10
DOCUMENT TYPE
SOP
LAST UPDATED
August 2026
PURPOSE

A procedure covering the receipt, triage, investigation and trending of product complaints, and the decision, classification, execution and effectiveness check of a recall including regulator notification. The two halves belong in one procedure because the transition between them is where sites struggle: the decision point at which a pattern of complaints becomes a market action needs to be defined before anyone is standing in front of it.

What's Inside

✓Complaint receipt and logging, with the triage that separates a potential quality defect from a non-quality enquiry
✓Investigation, root cause, and CAPA linkage, including retention and examination of any returned sample
✓Adverse-event identification and the handover to pharmacovigilance where a complaint carries a safety signal
✓Complaint trending and periodic review, so a pattern is detected before an individual complaint escalates
✓Recall decision process — who convenes it, on what trigger, and how the decision is recorded
✓Recall classification, depth, execution, reconciliation, and regulator notification with timelines
✓Effectiveness check, closure, and the appendices — complaint log and recall execution checklist

How to Use It

1Log every complaint and triage it, distinguishing potential quality defects from enquiries without discarding the record either way
2Identify adverse events at receipt and hand them to pharmacovigilance immediately, in parallel with the quality investigation
3Investigate to root cause and link corrective action; a complaint closed as 'no fault found' without examination is not investigated
4Trend complaints on a defined cycle so a systemic issue surfaces as a pattern rather than as a recall
5Define the recall trigger and the decision forum in advance, and record the decision and its basis when convened
6Execute to a defined depth, reconcile quantities, notify the regulator within the applicable timeline, and verify effectiveness before closure
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Purpose and Scope
2Complaint Handling
3Recall Decision and Classification
4Recall Execution, Notification, and Effectiveness
REGULATORY CONTEXT

21 CFR 211.198 requires written procedures for the handling of written and oral complaints regarding a drug product, with records maintained and investigations conducted. EU GMP Chapter 8 covers complaints, quality defects and recalls, expecting a person responsible for managing recalls, defined escalation, and notification of the competent authority. ICH Q10 places both within the pharmaceutical quality system. The recall trigger and depth appropriate to your product are your determinations, made with your regulator, and recorded in this procedure.

MAPPED STANDARDS
21 CFR 211.198EU GMP Chapter 8ICH Q10
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