Market Complaint Management in Pharmaceutical Industry

Regulatory Requirements

Adhering to FDA and EU GMP mandate robust complaint management process and reporting of serious quality defects

Types of Market Complaint

• Quality Complaint: Concerns related to product quality, such as physical appearance or packaging defects
• Adverse Drug Reactions (ADRs): Unintended side effects experienced by patient
• Product Defects: Like contamination, potency deviations, or labeling errors
• Counterfeit Products: Complaints about products that may be fake

Classification of Market Complaint

1. Critical Market Complaint

Complaints that pose a serious threat to patient safety or regulatory compliance. Example:

• Contamination with harmful substance
• Significant potency issue, incorrect dosage
• Labeling error that could lead to incorrect product use
• Response Time: Immediate investigation and action

2. Major Market Complaint

Complaints that could affect product efficacy or quality but are less likely to cause severe harm to patients. Example:

• Minor potency deviations that do not compromise safety
• Packaging defects that may impact product integrity
• Non-compliance with minor regulatory requirements
• Response Time: Prompt investigation within a defined timeframe

3. Minor Market Complaint

Complaints with minimal impact on product quality. Example

• Cosmetic issues, like discoloration
• Minor packaging defects without impacting product integrity
• Response Time: As per routine schedules

Market Complaint Receiving Channels

• Direct Reports: From healthcare providers or patients
• PV Systems: For reporting ADRs
• Customer Service: Hotline, email, and online forms
• Social Media & Newspapers: Publicly raised issues require rapid investigation
• Regulatory Authority reports submitted by bodies

Market Complaint Handling Process

• Receipt and Documentation: Log complaint and acknowledge receipt to the complainant
• Classify complaint then triage for urgency
• Investigation
  • Assign Investigation Team, including QA team
  • For ADRs, a mandatory medical assessment by PV team is required to address any patient safety concerns
  • Use RCA tools to identify root cause
  • Collect product samples for lab analysis if needed
  • Review previous complaints, historical data, and relevant batch record(s)
• CAPA
  • Develop a CAPA plan to address the RC and prevent recurrence
  • In severe cases, if a MC investigation identifies a critical safety issue, a product recall may be initiated to prevent further risk to patients
• Communication
  • Initial Response: Notify the complainant that complaint is received and being investigated
  • Investigation Outcome: Upon conclusion, communicate findings to the complainant, detailing any actions taken to prevent recurrence
• Documentation & Trending
  • Maintain detailed records of all complaints, investigations, and CAPA plans
  • Perform regular trend analysis on MC data for continuous improvement of product and process quality

Read also:

• GMP Compliance for Legacy Products
• Corrective and Preventive Action (CAPA) Process in GMP
• Reference and Retain Samples in Pharmaceutical Industry

Resource Person: Alaaeldin Rashad