In pharmaceutical industry, a market complaint or customer complaint is a very serious issue. Because it's related with patient safety and company reputation. In this article we try to discuss about how to correctly manage a market complaint in pharmaceuticals?
As per 21 CFR 820.3(b),
Complaint is any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for.
The Quality Assurance (QA) department is accountable that products being distributed for consumption are of good quality and have been manufactured in compliance with the GMP guidelines or regulations.
However, handling of complaints is also a part of Good Manufacturing Practice (GMP) therefore any GMP complaint should be taken seriously. You should have a well-designed GMP complaint handling system that can be readily implemented to tackle the issue (CAPA), and if necessary, recall the entire batch of that product from the market.
All complaints and other information concerning potentially defective products must be kept and reviewed according to written procedures. In order to provide for all contingencies, a system shall be designed to recall, if necessary, promptly and effectively products known or suspected to be defective from the market.
Stages of an effective complaint handling system are as follows:
1. Receipt of complaint
Complaints may be received from various sources either verbally, in written form, or by electronic means. The source of complaints may be the patient, healthcare professionals, regulatory agencies, qualified pharmacists, trade sources, distribution chain personnel or any other source.
2. Categorization and classification of complaint
Complaints can be classified into one of the follows:
- Critical
- Major
- Minor
3. Notification to regulatory agency or internal QA staff
4. Initiating investigation
Complaints involving product quality can be investigated with cross-functional teams, wherever applicable, as per the investigation procedure of the company.
Investigation can be performed by adopting suitable tools like fishbone analysis/Ishikawa, 5-Whys analysis, brainstorming, etc.
Batch records, in- process records, analytical records, stability data as applicable and all allied records must be reviewed as part of the investigation.
5. Receipt and handling of samples.
6. Risk Assessment and CAPA
7. Closure of the complaint
The complaint shall be treated as “Closed” after receiving feedback from the customer.
8. Trending
9. Historical review
Related:
References:
- EMA: GMP Chapter 8: Complaints, Quality Defects and Product Recalls
- FDA: How to Report Product Problems and Complaints to the FDA
