PRODUCT QUALITY COMPLAINT RATE (PQCR) IN PHARMA
What is Product Quality Complaint?
Product Quality Complaint is any communication received from customer, patient, doctor, distributor about deficiency related to identity, quality, durability, reliability, safety, effectiveness or performance of a drug product after it is distributed in market.
Simple meaning – Customer is complaining that product is not good.
It is different from Adverse Event. Adverse Event is side effect on patient body. Quality Complaint is defect in product itself.
– Tablet is broken in strip – This is Quality Complaint
– Patient got rash after taking tablet – This is Adverse Event (Pharmacovigilance)
– Sometimes one complaint can be both – e.g. bottle contains black particles and patient swallowed it and got infection.
What is Product Quality Complaint Rate (PQCR)?
Product Quality Complaint Rate is one of the 4 main Quality Metrics proposed by FDA in Quality Metrics Guidance 2015.
PQCR measures how many complaints received compared to number of units distributed. It shows how good your product is in market.
Formula of PQCR:
It is expressed as number of complaints per million units distributed.
Example: If you distributed 10 million tablets in one year and received 50 complaints, then PQCR = (50 / 10,000,000) x 1,000,000 = 5 per million.
Some companies also calculate PQCR per batch: (Number of complaints / Number of batches distributed) x 100
Types of Product Quality Complaints in Pharma
| Type of Complaint | Examples |
|---|---|
| 1. Physical Defect | Broken tablet, Chipped tablet, Powder in strip, Cracked capsule, Empty capsule, Tablet color change |
| 2. Packaging / Labeling Defect | Missing tablet in strip, Wrong label, Illegible printing, Leaking bottle, Carton damaged, No leaflet |
| 3. Foreign Particle / Contamination | Black particle in injection, Glass particle, Hair in bottle, Metal particle |
| 4. Lack of Effect / Efficacy | Tablet not working, Pain not reduced, BP not controlled. This is critical complaint. |
| 5. Taste / Odor Complaint | Bitter taste, Bad smell, Unusual odor |
| 6. Adulteration / Mix-up | Wrong tablet in strip, Two different tablets in same bottle. This is most serious – may lead to recall. |
| 7. Dissolution / Disintegration Issue | Tablet not dissolving, Capsule not opening |
Why PQCR is Important?
- Shows True Market Quality: In-plant testing shows batch passed. But PQCR shows what patient actually receives. If PQCR is high, it means in-process controls are weak.
- FDA Quality Metrics: FDA uses PQCR for risk-based inspection. If PQCR is high, FDA will inspect your site early.
- Early Warning: Increase in PQCR is early warning of bigger problem. If you ignore 2-3 complaints of black particles, later it may become recall.
- Quality Culture: How you handle complaints shows your quality culture. Companies that close complaints without proper investigation get warning letters.
Target / Acceptable PQCR in Industry
There is no fixed limit by FDA. Company has to set own target based on trend.
– Good PQCR: < 100 complaints per million units
– Average: 100-300 per million
– Poor / Needs Improvement: > 300 per million
But it depends on product type. For injectables, even 10 per million is high because particle complaints are critical. For oral tablets, slightly higher PQCR is acceptable.
For critical complaints like mix-up, foreign particle, lack of effect – Target should be ZERO.
How to Handle Product Quality Complaint – Step by Step Process
As per 21 CFR 211.198, all drug product complaints must be handled as per written SOP.
Complaint received by phone, email, sales team. QA logs it in QMS within 24 hours. Give unique complaint ID. Acknowledge to complainant.
Classify as Critical, Major, Minor.
– Critical: Mix-up, Wrong product, Foreign particle in injection, Lack of effect for life-saving drug.
– Major: Broken tablets, Leakage, Missing tablets.
– Minor: Carton dented, Printing slightly faded.
This is most important step. FDA always checks complaint investigation in inspection.
– Check if complaint sample returned. If yes, analyze in lab.
– Check batch manufacturing record (BMR) and batch packing record (BPR). Any deviation in that batch?
– Check other batches of same product. Is it isolated or trend?
– Check stability data – Any OOS?
– Check retained sample – Does retained sample show same defect?
– For particle complaints – Check visual inspection records, lyophilization, filling.
– For broken tablet – Check hardness, friability, packaging machine setting.
Use tools like 5 Whys, Fishbone, Fault Tree.
Example: Broken tablet – Root cause may be low hardness during compression + high vibration during transport + weak blister foil.
Take Corrective and Preventive Action.
– Corrective: What you will do for this complaint batch.
– Preventive: What you will do to avoid recurrence in future batches. e.g. Increase hardness spec, change foil quality, add extra check in visual inspection.
Every month, do trend of PQCR.
– Product-wise trend: Which product has highest complaints?
– Defect-wise trend: Which defect is repeating?
– Market-wise trend: Which market has more complaints? May be due to transport.
– Batch-wise trend: Is one batch causing many complaints?
Close complaint within 30 days (industry standard). Send response to complainant. If sample returned, send replacement if needed.
All complaint records must be retained for 1 year after expiry of batch.
Common Mistakes Companies Do in Complaint Handling (Warning Letter Points)
- Closing complaint without investigation: Writing “Complaint not justified” without checking BMR, retained sample.
- Not considering other batches: Investigating only complaint batch, not checking if same problem in other batches.
- Invalidating complaint as customer misuse without proof: e.g. Saying patient stored product wrongly, without data.
- Delay in closure: Complaint open for 6 months without justification.
- Not doing trend: Each complaint handled individually, no monthly PQCR trend.
- Mixing Quality Complaint and Adverse Event: Not reporting adverse event to pharmacovigilance team.
How to Reduce PQCR – Improvement Actions
- Improve packaging – Use better blister foil, better bottles, add desiccant
- Improve visual inspection – 100% inspection for injectables, AQL sampling for tablets
- Improve compression parameters – Right hardness, friability to avoid breakage during transport
- Training to operators – How to handle product during packing
- Transport validation – Do shipper validation for different climates
- Customer feedback – Take feedback from distributors about handling
Conclusion: PQCR is voice of customer. Lot Acceptance Rate shows internal quality, PQCR shows external market quality. Low PQCR means good quality culture and good manufacturing control. Every complaint should be treated as opportunity to improve, not as paperwork. FDA now focuses more on complaint investigation during inspection. Keep PQCR low, keep inspection risk low.
The information provided on this page is for educational and informational purposes only. It is not intended to provide regulatory, legal, or compliance advice.
Pharmaceutical regulations including FDA 21 CFR, EU GMP Annexes, ICH Guidelines, EDQM, WHO, and CDSCO requirements are subject to frequent updates and interpretation by regulatory authorities.
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About the Author
Mahummed Asif is a experienced pharmaceutical Quality Assurance professional and publisher of Pharmashare. He has worked with leading Pharmaceutical organizations and has developed extensive expertise in Quality Assurance, deviation management, investigations, CAPA, QMS, Product Life Cycle Management, change control, risk management, validation, product complaints, product recalls, and regulatory compliance. He is passionate about sharing practical pharmaceutical knowledge with professionals, students, and quality practitioners across the industry.