ICH Q7 clause 15: Complaints and recalls
The 6 audit questions covering clause 15, each with the objective evidence to request, the nonconformities most often raised against it and what to sample. Part of the free ICH Q7 API GMP audit checklist, which holds 350 items across 18 clauses.
All 6 questions for clause 15
Open any row for its objective evidence, common nonconformities and auditor tips. You can check items off as you go. This browser remembers your progress across all 18 clauses of this checklist.
§15 Complaints and recalls
15.10 Are there written procedures for recording, investigating, and responding to quality complaints?
- Complaint handling SOP
- Complaint log with all required fields
- Complaint investigation records
- Response letters to complainants
- Complaint trending reports
- Training records on complaint handling
- Multiple intake channels (phone, email, web, visits)
- Periodic complaint procedure audits
- Oral complaints not documented
- Complaint SOP exists but not followed
- Missing information in complaint records
- No trending of complaints
- Complaints closed without investigation
- Complaint categorization scheme does not distinguish quality complaints from logistics complaints
ICH Q7 §15.10 verbatim enumerates the required record fields (complainant name/address/phone, nature, date received, action taken, response, batch/lot decision). The standard names oral and written complaints as both in scope. ICH Q7 does not prescribe an investigation timeframe, intake channel inventory, trending methodology, or regulatory reporting framework — those are at the organization's discretion (and regulatory reporting follows jurisdiction-specific rules, not ICH Q7).
15.11 Do complaint records capture complete information about the complaint and the actions taken?
- Complaint records retention per schedule
- Complete complaint files with all elements
- Customer communication records
- Investigation findings documentation
- Root cause analyses
- Corrective action tracking
- Customer response records
- Regulatory notification records where applicable
- Complaint records destroyed prematurely
- Incomplete records missing investigation
- No root cause analysis
- Customer responses not documented
- Regulatory notifications not linked to complaint records
- Complaint records lack linkage to batch-level CAPA for systemic issues
- Complaint investigation does not include review of related stability data for the affected batch
Complaint retention aligns with other GMP records. Content must be comprehensive — not just the complaint itself but everything related: customer communications, internal investigation, lab results, batch review findings, root cause, corrective actions, customer response, regulatory notifications (if any). This complete record supports investigation of recurring issues and regulatory audits.
15.12 Are complaints investigated (including batch-record and trend review), with conclusions documented?
- Complaint investigation procedures
- Batch record reviews for complaints
- Previous complaint cross-referencing
- Testing of returned samples
- Root cause analysis documentation
- CAPA records for complaints
- Investigation timeline tracking
- QA review of investigations
- Investigations superficial or missing
- No batch record review for complaints
- Recurring complaints not connected
- No physical examination of returns
- Investigations closed without root cause
- Complaint investigation does not include review of related stability data for the affected batch
Complaint investigation is a structured activity. Scope: batch record review (was the batch manufactured correctly?), laboratory record review (were test results consistent with the complaint?), prior complaint review (recurring issue?), physical examination of returned product (if returned), analytical testing (if additional testing is needed). Root cause identification drives CAPA. Investigation should be completed in a defined timeframe.
15.13 Is there a written, quality-unit-approved recall procedure that is periodically tested?
- Recall SOP
- Recall decision authority documented
- Recall notification list (internal and external)
- Mock recall exercises
- Recall classification guidance
- Regulatory reporting requirements
- Recall effectiveness measures
- Recall team training
- No recall procedure
- Recall SOP untested (no mock recalls)
- Decision authority unclear
- Notification list outdated
- No recall classification guidance
- Mock recall exercise frequency not defined or last exercise overdue by more than one year
ICH Q7 §15.13 verbatim requires a recall procedure approved by the quality unit, tested via periodic mock recalls, defining the circumstances for recall, roles/authority of decision-makers, manner of initiation/execution/monitoring, and communication with authorities/customers/distributors plus disposition of recalled material. ICH Q7 does NOT prescribe a recall classification scheme — the 'Class I, II, III' framework is FDA-specific (21 CFR 7.3) and does not appear in ICH Q7. Notification timing, decision authority hierarchy, and effectiveness measurement methods are at the organization's discretion.
15.14 Does a recall assessment consider whether other batches or intermediates are affected?
- Scope determination methodology
- Root cause linking to scope decisions
- Associated batch identification procedures
- Material traceability supporting scope
- Equipment history supporting scope
- Cross-product impact assessment
- Scope expansion procedures as new information emerges
- QA approval of scope decisions
- Scope determined too narrowly, missing affected batches
- No methodology for scope determination
- Scope decisions without QA approval
- Scope not expanded when new information emerges
- Cross-product impact not assessed
- Recall scope assessment lacks documented methodology for identifying shared-equipment batches
- Regulatory authority contact list not verified for accuracy within the last twelve months
Scope determination is critical — a narrow scope risks leaving defective product in the market; a broad scope creates unnecessary disruption. The scope assessment considers: same batch (always), same manufacturing date range, same raw material lots, same equipment, same personnel, same process deviation. For equipment-related failures, all products made on that equipment in the relevant timeframe should be evaluated. For material-related failures, all products using that material should be evaluated.
15.15 Are regulatory authorities notified for recalls involving serious or life-threatening situations?
- Regulatory notification procedures by jurisdiction
- Customer notification templates
- Notification timing requirements
- Recall communication SOPs
- Regulatory contact information current
- Notification effectiveness tracking
- Training on regulatory requirements
- Post-recall reporting
- Regulatory notification delayed or missing
- Customer notifications unclear or incomplete
- Notification procedures untested
- Regulatory contacts outdated
- No tracking of notification effectiveness
- Regulatory authority contact list not verified for accuracy within the last twelve months
Regulatory notification requirements vary by jurisdiction and severity. Class I recalls (life-threatening) require immediate notification (typically within 24 hours). Class II (temporary harm) and Class III (unlikely harm) have longer timeframes. Notifications must be accurate and complete. Customers must also be notified through clear communications that include: product identification, reason for recall, customer action required, return procedures, contact information.
Each item shows its evidence, common nonconformities and auditor tips. The clause index has the PDF of all 350 items, formatted for a clipboard.
The rest of the ICH Q7 API GMP audit checklist
350 items across 18 clauses. Back to the clause index.