Handling Pharmaceutical Complaints the Right Way

When a pharmaceutical complaint lands, the clock starts on protecting patients, preserving product integrity, and demonstrating compliance. We support Wholesalers, Manufacturing Importation Authorisation (MIA) Holders and Marketing Authorisation Holders (MAHs) in meeting these critical obligations.

Principles of Complaint Management

Record Every Complaint

No complaint is too minor. All complaints relating to product quality, distribution, packaging, temperature conditions, suspected falsified medicines or efficacy must be documented. Each complaint should have a unique reference number and complete details including product, batch, source, description, date, and reporter.

Investigate Systematically

Investigations should follow written procedures. Use root cause analysis (RCA) to determine if the issue is isolated, recurring, or systemic. Maintain objectivity and involve relevant functions – QP, RP, QA, Manufacturer, MAH, and PV.

Assess Risk and Escalate Appropriately

Prioritise complaints by patient risk, for example adverse events, falsification, or product defects. Escalate to regulators (MHRA, HPRA, EMA) if the issue could lead to recall, serious safety concerns, or supply restrictions.

Implement Containment Actions

Quarantine impacted stock immediately if the risk requires it. Stop distribution until the risk is understood, and notify customers where appropriate.

Document Outcomes and CAPA

Close complaints only when the investigation is complete and corrective/preventive actions are identified. Capture actions in the Quality Management System (QMS) and follow up on their effectiveness.

Trending and Review

Regularly review complaint data for patterns across product, site, supplier, and transport. Use complaint trending in Management Review and as input into continuous improvement.

Maintain Regulatory Readiness

Records must be complete, retrievable, and ready for inspection. Complaints, recalls, and deviations are frequently sampled during GDP inspections.

Common Problems Observed in Inspections

Investigations Raised Long After the Event

Regulators expect prompt initiation of investigations to ensure accuracy of data and enable timely risk assessment. Delays weaken the credibility of the investigation, increase the risk of recurrence, and may indicate an ineffective quality system. Timelines for complaint recording and investigation completion should be documented in written procedures.

Root Cause Analysis Listed as a CAPA to Enable Premature Closure

Inspectors frequently see investigations being "closed" on the basis that RCA will be done later as part of a CAPA. This is a red flag: a complaint or deviation cannot be meaningfully closed without having established the root cause. Treating RCA as a future action undermines the integrity of the investigation and can suggest a culture of box-ticking rather than real problem-solving.

Large Proportion of CAPAs Overdue or Repeatedly Extended

A backlog of overdue CAPAs demonstrates poor prioritisation, insufficient resources, or weak oversight by senior management. Extensions without clear justification or risk assessment can signal that CAPAs are not being taken seriously. Regulators view this as evidence of a failing quality management system, as issues are not being effectively resolved.

"Human Error" Frequently Cited as the Root Cause

Over-reliance on "human error" suggests superficial investigation and a failure to address underlying systemic issues. True root cause analysis should go deeper – why did the error occur? Was it training, workload, unclear SOPs, poor design of equipment or processes, or lack of supervision? HPRA and MHRA inspectors both emphasise that "human error" should only be accepted when all potential contributing factors have been ruled out and evidence supports the conclusion.

How regenold Can Help

Effective complaint management is a cornerstone of pharmaceutical quality systems, ensuring that every concern – no matter how minor – is captured, investigated, and resolved in line with EU regulatory expectations. By recording and analysing complaints, companies protect patient safety, identify and address quality defects, and strengthen supply chain integrity. Robust complaint handling also demonstrates regulatory compliance, supports continuous improvement through CAPA and trend analysis, and fosters trust with regulators and patients.

Our experienced team can help you protect patient safety, uphold product integrity, and demonstrate a culture of quality excellence.