Market Complaint in the pharmaceutical industry, Definition, Types, classification, Procedure/Handling of Market complaints, Investigation, Corrective action, Reporting of Market Complaint. EU GVP guideline, ICH Guideline E2A, US FDA CFR Part 211.
Definition of Market Complaint in the pharmaceutical industry
A market complaint in the pharmaceutical industry refers to any communication from a customer or healthcare professional expressing dissatisfaction with a pharmaceutical product.
Types of Market Complaint in the pharmaceutical industry
This Market Complaint can be related to various aspects of the product, including:
- Quality: This includes complaints about product defects, impurities, discoloration, incorrect dosage, contamination, or any other issue that affects the product’s safety and efficacy.
- Efficacy: This includes complaints about the product not working as expected, lack of therapeutic effect, or adverse reactions.
- Safety: This includes complaints about serious side effects, allergic reactions, or any other safety concern related to the product.
- Labeling: This includes complaints about inaccurate or misleading information on the product label, missing information, or illegible text.
- Packaging: This includes complaints about damaged packaging, defective dispensing mechanisms, or tamper-evident seals not working properly.
Market complaints are classified based on product quality defects into one of the follows:
- Critical
- Major
- Minor
Procedure/Handling of Market complaints
1. Receiving Market complaints
Market complaints can be received verbally (through phone calls or direct conversations) or in writing (through letters, emails, or complaint forms). They can come from various sources, including:
- Patients
- Healthcare professionals (doctors, nurses, pharmacists)
- Consumers
- Wholesalers and retailers
- Regulatory agencies
All complaints should be documented and assigned a unique identifier for tracking purposes.
2. Investigating Market complaints
The company should investigate the market complaint thoroughly to determine the root cause and identify any potential risks.
3. Corrective actions
The company should take appropriate corrective actions to resolve the complaint effectively and prevent similar occurrences in the future.
4. Report to the Regulatory authorities
Depending on the severity of the complaint and the regulatory requirements, companies may need to report certain complaints to regulatory authorities.
Regulatory guidelines for Market complaints in pharma
Several international regulatory guidelines address market complaints in the pharmaceutical industry. Some key examples include:
- ICH Guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting: This guideline defines the criteria for expedited reporting of serious adverse events to regulatory authorities.
- EU Commission Guideline on Good Pharmacovigilance Practices (GVP): This guideline provides detailed guidance on the pharmacovigilance system for human medicinal products in the European Union.
- US FDA Code of Federal Regulations (CFR) Part 211: This regulation outlines the requirements for cGMP compliance for drug products, including the handling of market complaints.
- ICH Q7 (15 & 17.7): Complaints & Recalls
- ICH Q9: Quality Risk Management
These guidelines emphasize the importance of having a robust and effective system for handling market complaints to ensure patient safety and product quality.