Handling of Pharmaceutical Market Complaints (Regulatory requirements)


Complaint is defined as statement that is something wrong or not good enough, which shows customers dissatisfaction about the company or product.Tabletfailure

Market complaints are considered as any written or oral communication received from a complainant (Customer, Marketing department, distributor, retailer and regulatory authority) regarding the defects in the product quality like purity, potency, safety etc. including its physical characteristics, packing, labeling.

The process of manufacturing passes through many critical steps like in-process checks, quality tests, audits as well as the evaluations along with other elements of quality like validation. After following all critical steps, the final hurdle is to make sure that product is successfully manufactured predefined quality.

However, market complaint are almost unavoidable. A good complaint handling system gives the company an opportunity to improve the quality of their products, being a good tool for the maintenance of Good Manufacturing Practices and a way to establish a committed relationship with their customers.

Complaint handling is a Good Manufacturing Practice (GMP) requirement, since all complaints concerning potentially defective products must be carefully reviewed according to a written procedure. Besides a regulatory obligation in several countries, a good complaint handling system gives the company an opportunity to improve the quality of products, control methods and manufacturing process, being a good tool for the maintenance of GMP. Therefore, the Marketing unit faces a great opportunity to recover customer satisfaction and establish a committed relationship between customer and company.

There is a regulatory guidance on pharmaceutical costumer complaint management. cGMP expectation of  pharmaceuticals market complaint are blew:

  1. Collecting Complaint Related Information
  2. Technical Investigations
  3. Corrective Action
  4. Monthly Report and Trend Analysis

1. Collecting Complaint Related Information: There should be a clearly defined system for collecting complaint related information. All the relevant personal should be understood their roles and responsibilities as well as the process related to the complaint. Besides, the individual responsible for collecting information related complaints from consumers or patients and consumers must ensure timely and consistent collection of the same.

2.0 Technical Investigations: Nature of complaint should be fully understood before the investigation starts. Complaint record, investigation process and result should be recorded, which is a evidence of an action, event or decision. Complaint file should be update at all time because inspectors or auditors are highly interested in reviewing the complaints file. When a complaint sample is being awaited then investigation can be kept open for some time. The investigation conducted should extend other pharmaceutical products that could be possibly be impacted. Maintain the record each serious complaint received by the facility for at least three years from the date the complaint was recorded.

3.0 Corrective Action: For all confirmed complaints, corrective actions must be implemented. These actions can range from a simple and quick training to some employees to a formal Corrective Action and Preventive Action (CAPA) handling. The criteria for choosing appropriate action depends on the nature of the complaint.

Solution should be taken in order to reduce the risk that consumer could suffer. A company should make use of quality risk assessment tools to define the potential harm to patient as well as likelihood its occurrence. 

Complaints data should also be communicated to the relevant regulatory authorities and also utilized for product quality improvement purpose.

4. Monthly Report and Trend Analysis: Monthly reports should be elaborated in order to evaluate the amount and the nature of the complaints received and to perform a trend analysis of these complaints. The monthly reports must answer the following questions: How many complaints did the company receive in the period? How many were confirmed? How many were non-confirmed or were counterfeit/tamper suspicion? It is also important to know the ‘top 10 products’ which received the majority of complaints, the nature of these complaints, batches involved, the root causes of confirmed complaints, how many free offer products were given to customers (to reimburse for the ‘complaint samples’ returned for analysis) and how much the complaint handling cost the company.