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Himani Devliyal
Department of Pharmacology,
Delhi Institute of Pharmaceutical Sciences and Research
Delhi University, New Delhi

This article covers fundamental basics of product quality complaint. We would learn what product quality is all about, how the product quality complaints are made, processed, investigated and changes implemented. Also we would go through the basics of case processing, how the complaints are classified, categorized based on the priority and then investigated. We would also go through the formal process of responding to the customer and increasing their faith in the company.
A PQP (product quality problem) can be defined as an issue arising due to change in color, odor, appearance, quality, safety and effectiveness of a product. A PQP is a grave concern and is directly related to the efficacy and safety of a drug.


PharmaTutor (ISSN: 2347 - 7881)

Volume 2, Issue 10

Received On: 11/07/2014; Accepted On: 27/07/2014; Published On: 01/10/2014

How to cite this article: H Devliyal; Product Quality Complaint Management in Pharmaceutical Industry – An Overview; PharmaTutor; 2014; 2(10); 8-16

Safety has been a prior concern for everyman since historical times. Today what ever we buy may it be a simple consumable item or a general medicine, we want to be cent % sure on its effectiveness and safety. Safety and efficacy of a medicinal product go hand by hand. A very efficient product will always carry some degree of precarious nature in it. Times are gone when people used to be the guinea pigs for the safety assessment of medicine. We understand, react and vocalize for the uncomfort we face due to the use of drugs.  Therefore this is a need of the hour that every one of us should be extra vigilant regarding the safe use of medicines.

Handling product quality complaints is a serious matter in industries. Complaints should be taken as positive attributes and should be welcomed. There should be nothing like a blame game in handling any complaint. The complainant shows a mirror to the company by complaining about the product and there is always a scope of improvement. It is very important in health care sector that whatever a company is delivering to the consumers, it should be complemented, commented, criticized and suggested for a modification.

Near about 5% of the population using the product will report a complaint and other just take pleasure in gossiping. The product quality complaint department in pharma companies procures extra information on their product disabilities and work on improving them. The complaint management system need to be extremely fair and justified. There should be an assurance of confidentiality, an attempt to implement the suggestive action and timely response to the complainant.

What is product discrepancy and how it is identified?
Here are some examples of typical product quality complaints generally encountered by the consumers. These may be ignored most of the times but the intelligence says there should be reported either to the regulatory agency or to the manufacturers.

* If the product has organoleptic issues such as}
·   Bad taste,
·   Bad odor
·   Appearance problem

* If the product exhibits lack of efficacy

* If there is suspected contamination

·   Any foreign object in the product
·   Insect leg in the tablet
·   Bug in sealed bottle

* If the product has questionable stability

* If the product has poor packaging and labeling
·   Shortage of pills
·   Illegible label print
·   Broken pills
·   Missing desiccant
·   10mg pills found in 20mg bottle
·    Empty blister pack
·    Blister pack hard to open

* If there is medication error
·   Accidental intake of medicine due to resemblance with other medicine

* Formulation errors
·   Tablets with disintegration and dissolution issues
·   Split tablets
·   Air in tube
·   Holes in the tablet
·   Intact tablets passed in the stool
·   Suspension come up with short doses
·   Hair hanging out of the pill

* Others
·   Burned seal
·   Deformed and melted capsules
·   Capsules contents spilled in the bottle
·   Cartons exposed to moisture
·   Cracked and chipped tablets.
·   Fiber embedded in the tablets
·   Griddy product
·   Illegible Logo
·   Ink spots on the tablets
·   Coating defects-uneven coating and pitting
·   Missing applicator tip or Missing insert

How the complaints are handled
There is always a resolution to every problem, and every mistake can be conquered that should be the adage while handling the complaints. It’s quite a complex task to handle but can lead to an astonishing change if handled in a proper way.

There are certain points which help while handling complaints. Improvement in quality will always increase trust in the customers.

  1. Understand consumers need
  2. Listen to them and react to the situation accordingly
  3. Accept appreciation and criticism positively
  4. Avoid reoccurrence of mistakes
  5. Accept feedback
  6. See the complaint as an opportunity for improvement
  7. Invite criticism
  8. Maintain credibility

How the complainant could make sure that the complaint has reached the right person
For this the companies has there safety website where online complaint can be logged. Most of the companies provide there drug safety contact information for reporting ADE and PQCs directly to the manufacturers. Moreover the consumer/patient can directly contact the pharmacist and then the pharmacist can contact the concerned manufacturer. The consumer participation is very important in the process. The complainant should be kept in loop in the whole process.

How are the complaints handled in Pharmacovigilance department
While processing a complaint at particular corporations there are certain steps which need to be followed:
1. A good system to procure complaints 1

a) Mails
b) Telephone
c) Facsimile
d) A known person in that company

2. Documenting the complaints on a complaint form

3. Triaging of cases according to priority

a) Legal cases
b) Cases through regulatory authority
c) Serious cases
d) Threatened liability

4. Processing of cases in a suitable database

5. Sending acknowledgement letter to the complainant

6. Procuring samples for investigation through 222 form in case the product is a controlled substance.

7. Significant follow ups are also essential

8. Sending sample for investigation

9. Collecting investigation reports

10. Sending the response letter to the complaint.

11. In case of refund/replacement request, the same is done through customer service

12. Requesting feedback from the complainant.

13. Confidentiality and Fairness

14. Medical Evaluation

15. The case should re-open upon request



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