Complaint Handling
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
The documented system for receiving, logging, evaluating, investigating, and closing complaints from patients, customers, or healthcare professionals about a marketed product’s identity, quality, durability, reliability, safety, or performance — including triage steps that route potential adverse events to pharmacovigilance and potential quality defects toward a recall assessment.
A complaint-handling system begins with intake — through any channel, including phone, email, sales representatives, or a call center — and requires every complaint to be logged, given a unique reference, and triaged for severity and type within a defined timeframe. Complaints alleging an adverse event must be routed to pharmacovigilance regardless of how they were classified initially.
Investigation depth is risk-based: a single cosmetic packaging complaint may warrant a simple review, while a complaint suggesting a potential quality defect that could affect other units in the batch triggers a full investigation, retained-sample testing, and an assessment of whether a recall is warranted.
Trending of complaints by product, batch, defect type, and site is a required input to periodic product quality review and management review, since a cluster of similar complaints is often the first external signal of an emerging quality problem.
- —Every complaint is logged, uniquely referenced, and triaged regardless of channel
- —Adverse-event-related complaints must be routed to pharmacovigilance
- —Investigation depth scales with potential patient/product risk
- —Complaint trending feeds product quality review and recall decision-making
21 CFR 211.198 (Complaint files); 21 CFR 820.198 (Complaint files, devices); EU GMP Part I Chapter 8
Frequently asked questions
What is Complaint Handling?
The documented system for receiving, logging, evaluating, investigating, and closing complaints from patients, customers, or healthcare professionals about a marketed product’s identity, quality, durability, reliability, safety, or performance — including triage steps that route potential adverse events to pharmacovigilance and potential quality defects toward a recall assessment.
Which regulations cover Complaint Handling?
21 CFR 211.198 (Complaint files); 21 CFR 820.198 (Complaint files, devices); EU GMP Part I Chapter 8