Market Complaints in Pharmaceuticals: A Brief Review on its Handling, Investigation and Reporting.

 

Vamshi Krishna T.¹*, Lalit Kumar¹, M. Sreenivasa Reddy¹, Muddukrishna B.S.²,

Girish Pai K.¹**

¹ Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal Karnataka State, INDIA-576104

⁴Department of Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal University

Manipal, Karnataka State, INDIA-576104

 

ABSTRACT:

Any product launched in the market can receive a “Market Complaint” if the product is not meeting the customer requirements or may be for the presence of any critical defects. For instance, it can be product of any area like fast moving consumer goods, electronic gadgets, cosmetics and medicinal product etc. When it comes to medicinal product, it is expected to be of highest quality and efficacious. A product is safe and efficacious provided the medicinal product meets certain important criterions with respect to parameters like safety, identity, strength, purity and quality. In day to day life, a medicinal product can also receive a market complaint. Unlike any other product, here in this case, the user is a patient and hence its impact and implications are very serious in nature. A patient is already suffering from sickness or serious illness depending on the disease state and therefore a medicinal product is expected to be safe for usage, efficacious (or) of best quality as expected by the patient community. Quality is the responsibility of all personnel involved in manufacturing a product, its testing and release. A strong Quality Assurance (QA) system with commitment for quality at plant level will reflect positively on product quality resulting in a product with zero defects. A manufacturing unit with sincere QA team will be able to deliver a defect free medicinal product to patients. In this article, we have tried to outline the important aspects of market complaints, various types, its handling, investigation and reporting. In a nut shell, it is very much essential to have competent personnel at levels during manufacturing. Finally a strong regulatory authority for implementing the rules and regulations with adherence to guidelines from time to time will help the patient in receiving right quality of medicines in right time.

 

 

 

1. INTRODUCTION:

In simple words, a complaint is nothing but statement of grievance reported by a customer or patient and a person who complains is known as complainant. In pharmaceuticals, market complaint cannot be treated lightly and complaints of any nature, be it minor or major, all complaints are equally important and needs proper investigation with corrective action and preventive actions. Basically a complaint can be classified into two types, namely minor and major complaints¹.

 

Minor complaints do not have any direct impact or adverse effects on patients. These are complaints of minor consequence such as, physical damage to the packs, short supply, poor presentation of the product pack etc. On the other hand, major complaints have direct impact on patients and may lead to adverse effects or toxic reactions and can be lethal in some extreme cases. These are complaints of major consequence such as, changes in chemical/physical attributes of the product, complaints related to stability, Abnormal impurity levels, packaging complaint, for presence of any extraneous matter, product mix-ups/batch mix-ups, uncoded or wrongly coded product with respect to overprinting details like Batch Number, Manufacturing or Expiry dates etc¹.

 

The user community i.e. doctors, paramedical staff like pharmacists or nurses and patients are having every right to complain the defects to concerned authorities or manufacturer. Market complaints can be of physical, chemical or microbial issues. Examples for physical defects include discoloration of uncoated tablet, improper coating on tablets, presence of black particles etc. Examples for chemical defects include pH out of the specification limits, fall in assay, increase in impurity levels etc. Examples for microbial issues include microbial contamination of sterile products or fungus development in liquid orals since both these products are aqueous based.

 

Procedure for handling, investigation and reporting of market complaints¹

The manufacturer shall have a written Standard Operating Procedure (SOP) in place for handling, investigation and reporting of market complaints. There shall be a format for receiving complaints and is commonly known as customer complaint communication form and in general market complaints are received from customers with full details in the prescribed complaint form by concerned staff of marketing department. In case of major complaints, it is a good practice and ideal to start the investigation of market complaint within 24 hours of receipt of such complaint. Documentation plays a critical role and at every step of investigation all the findings are recorded in appropriate registers.

 

All complaints related to Quality Control shall be investigated by Quality Control (QC) Head in coordination with QA Head^2,3. This shall include review of various records / documents like analytical records, sampling and release records and other related raw data. The QC Head shall compare the reserve sample of batch corresponding to the complaint and report to QA Head with his observations. QA Head shall evaluate the report. The decision for analysis shall be taken by QA Head.

 

A suggested brief and generalized procedure for handling “Market Complaints” is depicted in this flow diagram

 

 

If the data indicates variance with initial value reported in certificate of analysis (COA) (such as drop in Assay or rise in impurities but within limits), QA Head shall proceed with detailed investigation including review of analytical reports, quality of raw materials and retesting of raw materials if required etc.

 

QA Head can seek additional information from the customer namely, methods, sample handling, storage conditions etc. through the Marketing department. If the analysis reveals any stability related problem, QA Head may investigate batch history, storage and distribution. If no abnormality is found, he shall seek help from Research & Development Head and QC Head for additional inputs.

 

All complaints related to manufacturing shall be investigated by the Production and QA Heads^2,3. QA Head and Production Head shall review various records / documents during investigation. These may include executed batch processing records and raw data like equipment log books, environmental monitoring records, cleaning records of manufacturing areas etc. QA Head shall then communicate a summary of findings in a report format, ‘Customer Complaint Report’ within 30 working days to the Marketing department. A report shall also be forwarded to complainant through customer complaint report format. A copy of report shall be sent to Management for information purpose. The QA department shall record summary of findings in the Market complaint record. The QA Head shall ensure all quality related complaints are taken to their logical conclusion. QA Head shall monitor the corrective actions taken and ensure the effective closure of complaints. In extreme cases, if the investigation findings require withdrawal of batch from the customer/market, the QA Head shall intimate this to Marketing Head^4,5. The recall shall be initiated by the QA Head in co-ordination with supply chain department or distribution department as per SOP on Product Recall.

 

CONCLUSION:

Market complaints can be avoided at plant level if there is strong QA system in place which will ensure strict adherence to SOPs, no dilution of GMPs and systems, proper training and development of staff at all levels.

 

A committed QA team and strong in-process QA personnel in shop floor will definitely reflect positively on product quality. This in turn is dependent on management’s commitment for good will of brands and market value of any given product.

 

Management should review the systems and other requirements in manufacturing facilities from time to time, which will enable them to procure cGMP model equipment, update or modify facility as per current requirements and recruit personnel with high competency levels.

 

At the same time, it is the responsibility of all people involved in manufacturing to learn from mistakes and avoid recurrence of similar market complaints in future.

Finally, it is the responsibility regulatory body to monitor the functioning of each manufacturing units as per GMP and laid down guidelines.

 

REFERENCES:

1.       SOP for handling of market complaints in pharmaceuticals, http://www.pharmaguideline.com/2011/08/sop-for-handling-of-market-complaints.html, Accessed on 02/04/2013.

2.       Good manufacturing practices for premises, plant and equipment for pharmaceutical products (Schedule M), Drugs and Cosmetics act 1940 (2005). Published by Government of India, Ministry of Health and family welfare. pp: 386 – 436.

3.       Rules and guidelines for pharmaceutical manufacturers and distributors, Section II- Good manufacturing practices, MHRA, RPS Publishing, London; 2007. pp: 38-270.

4.       Good Manufacturing Practices, Chapter 1078, United States Pharmacopeia and National Formulary (USP 32-NF 27). Rockville, MD: United States Pharmacopeia Convention; 2009. pp: 2906-2915.

5.       D.A. Sawant. Market recalls and market withdrawals of drug product. In Pharma Pathway. Edited by D.A. Sawant, India. 2004. pp: 1.54-1.55.

 

 

 

Accepted on 15.10.2013                © RJPT All right reserved