This blog covers:
- An introduction to PQC (Product Quality Complaint)
- Reports associated with PQC
- MedDRA coding conventions
Table of Contents
Product Quality Complaint (PQC)
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication alleging deficiencies related to a product’s identity, quality, durability, reliability, safety, effectiveness, or performance after its release and distribution in the market.
This includes suspected medicine failures, damaged or missing products, incorrect strength or color, damaged packaging, missing patient information leaflets, broken or defective needles or syringes, counterfeit medicines, and other quality-related issues.
Chances of PQC
A Product Quality Complaint (PQC) may arise due to the following reasons:
- Lack of therapeutic effect
- Harmful effects under normal conditions of use
- Incorrect qualitative or quantitative composition
- Unfavorable benefit-risk balance
- Failure to implement proper controls in the manufacturing process
- Non-fulfillment of requirements and obligations for the granted Marketing Authorization (MA)
“Ensuring product quality isn’t just about compliance—it’s about patient safety, trust, and the integrity of healthcare.”
Examples of PQC in Reports
Here are some examples of PQC cases:
- Damaged packaging
- Broken or defective syringe
- Evidence of contamination
- Missing lot number
- Presence of visible foreign substances
- Missing or incorrect product label
- Missing package insert
- Abnormal color or appearance
- Vaccination failure
Product Complaint Management in Pharmacovigilance
Information Required for a PQC Report
The following details must be collected for proper tracking and effective recall:
- Name and phone number of the reporter
- Product name, strength, and pack size
- Batch/Lot number and expiry date
- Retailer details (wholesaler, hospital, pharmacy)
- Brief description of the complaint
- Patient details
- Investigation findings, actions taken, and root cause analysis
Role of Pharmacovigilance in PQC Management
- Conducting investigations
- Detecting quality defects
- Identifying safety signals linked to quality defects
- Informing the Marketing Authorization Holder (MAH)
- Performing medical evaluation
- Analyzing Adverse Events Following Immunization (AEFI)
Does It Qualify as a Valid Report?
Yes, it is considered a valid report and should be documented to identify product defects and ensure the safety of medicinal products. Certain events, such as lack of efficacy and vaccine failure, are regarded as serious and unexpected, requiring expedited reporting in some regulatory jurisdictions.
In cases of serious or potentially life-threatening situations, local, national, and international authorities must be informed.
To assess and review the safety impact, all reports must be properly documented, processed within pharmacovigilance systems, and diligently submitted to the relevant authorities.
Examples of Signals Related to Quality Issues
- Reports of infection due to sterility issues
- Lack of efficacy concerns
- Unusual increase in reports of expected or serious AEFIs
- Vaccine failure
MedDRA Coding Conventions
MedDRA is not traditionally used as a coding library for devices; however, it includes certain terms closely related to both drugs and medical devices used by consumers.
Despite its limitations, MedDRA provides coding for specific product quality complaints, covering both medicinal products and medical devices handled alongside medications.
The most commonly used System Organ Classes (SOCs) for PQC coding include:
- Injury, Poisoning, and Procedural Complications
- Product Issues
Key Takeaways
Product Quality Complaint (PQC) – PQCs qualify as valid reports and should be documented for safety monitoring and regulatory compliance.
MedDRA Coding Conventions – MedDRA provides specific coding terms closely related to product quality complaints, ensuring standardized classification.
Essential Information for PQC Handling – Key details such as batch number, manufacturer information, and patient details are crucial for effective case management and investigation.
Pharmacovigilance Role in PQC – Pharmacovigilance (PV) plays a crucial role in investigating, detecting quality defects, identifying safety signals, and informing regulatory authorities.
Importance of Documentation – Proper tracking and reporting of PQCs help ensure patient safety, regulatory compliance, and prompt corrective actions.
How can we assist you with ICSR management?
Closely monitoring backlogs.
Preparing CAPA and ensuring diligent monitoring.
Enhancing your regulatory submissions.
Anyone of above your concerning area and no worries just contact us
Conclusion
This write-up provides clarity on handling product quality issues in pharmacovigilance case processing. We have addressed key aspects that may not always be well understood.
Our goal was to present this information in a simple and accessible way, making a potentially complex topic easier to grasp. We hope this blog has given you valuable insights and a better understanding of the subject.
If you feel we have missed any crucial details, we welcome your feedback. Constructive criticism helps us explore topics more deeply and improve our content.
Feel free to share this with your friends and colleagues. Thank you for reading!
Acronyms:
- PQC: Product quality compllaint
- AEFI: Adverse Event Following Immunization
- SOC: System Organ Class
- MedDRA: Medical Dictionary for Regulatory Activities
- MAH: Marketing authorisation holder
Leave a Reply