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