Handling of complaints is a crucial activity in Good Manufacturing Practices. This article deals how the complaints are to be handled to maintain a healthy relation between customer and pharmaceutical firm.
1.0 Introduction
Complaints often indicate dissatisfaction among the customers in terms of quality or service or follow-up. There should be a proper system in the pharmaceutical companies to handle complaints of any kind so the trust of customer is not lost. This activity ensures Good Manufacturing Practices within the company. Complaints can be regarding product quality, packaging, service, communication, delivery, response time and follow up.
In pharma companies most noted problems are observed in product quality where there may be unnecessary particulate matter or substandard products due to which many products face recall or ban of their drugs.
Here the customer can be end user of the product or a dealer who buys the products from the company. When they are not satisfied with the product they give complaint to the concerned people either in form written communication or verbal. The action from the customer can be through filing complaints (voice) or by stopping the use of the product (exit).
1.1 Classification
Complaints are classified into A, B, C type as follows:
i) Type A Complaints
This category includes critical complaints due to which the product needs to be withdrawn from the market, they include
ii) Type B Complaints
This category includes major complaints in
iii) Type C Complaints
This category includes minor complaints in
1.2 Personnel
Unit Head
Production Head
Quality assurance Head
1.3 Procedure for Handling Complaints
In compliance with GMP regulations following steps which are generally followed to handle complaints. They are:
1.3.1) Receiving complaints
There should open channels to receive complaints via email, toll free numbers, and chat rooms. There should be a person to receive the complaints and ensure that they are carried out to quality assurance department for investigation.
The complaint filed for investigation should include contact information like name, address, phone number and email.
Later the problem due to the product should be described along with its product name, lot number, manufacturing date and expiry date, dosage of product at which the problem has occurred and any additional information can be attached
Each complaint should be given a code
When an interview is done then the procedure for complaint handling should be explained to the customer. The time estimate for investigating and giving feedback should be explained to the customer.
The personnel who is in charge for handling complaints should see that the defective product is sent to the company for further research, the defective product is called complaint sample and the whole process should be documented.
1.3.2) Investigation
The quality assurance department further investigates the issue in two ways i.e., documented approach & analysis of the product in the lab.
Documented approach checks the complaint with historical data or occurrences in the past. Complaint files are also scrutinized for any complaints of same nature.
Batch records are checked for historical occurrences of the same event and how they are solved.
Analysis of the product in the lab involves the analysis of complaint and retained samples
If the sample is not sent by the customer then the analysis is carried out with the remaining samples.
A complaint officer is selected from among the personnel to check the investigation process. He should have thorough knowledge on manufacturing and quality process. He will be responsible for selecting an approach which at its best solves the problem and further he should report from quality assurance to other production, marketing, regulatory, legal departments regarding the investigation.
After thorough investigation the QA department gives the final status in three following ways:
i) Confirmed Complaint
Here the retained and complaint sample show out of specification results or the complaint sample alone shows out of specification results.
In few cases where a tablet may be missing in strip and the retained sample did not show any deviation then it is filed as confirmed complaint as there is a quality problem
ii) Non- Confirmed Complaint
Here the retained and complaint sample are in compliance with the specifications or the complaint sample is alone out of specifications then it is taken as non-confirmed complaint. These complaints arise due to improper storage conditions where they are stored at improper specified conditions.
When tablets change their appearance due to light exposure or humidity conditions then they are treated as non-confirmed complaints
iii) Tamper or Counterfeit suspicion
Here the retained sample is in compliance with the specifications but the complaint sample is not due to tampered drug.
This can occur when the packaging of the product is different from the original product packing or any foreign substance is added to the product which makes it look entirely different from the compliance sample.
The legal department should be informed on encountering counterfeit products. Such issues should be solved in compliance with the health authorities & regulatory bodies of that country.
1.3.3) CAPA – Corrective and preventive action and Feedback
Corrective actions should be implemented after analysis. They may include from training the employees to handle CAPA.
Inputs from various departments should be taken like production, QA, QC and regulatory etc.
If any type A complaints are received then the product may be recalled. The investigation results are to be given as a feedback to the customer explaining the action being taken with the product.
Response letter and replacement product should be sent to the customer by the company as the complaint sample given by the customer was used for analysis and problem was found in it.
1.3.4) Reports & Trend analysis
Periodic reports should be given to evaluate the quality and quantity of complaints received and further trend analysis is done on the complaints. The reports given by month should include how many complaints are received? Are the complaints confirmed or non-confirmed, counterfeit suspicion?
Reports should include the cost involved in analyzing and investigating the complaint?
Copy of the report should be given to staff of departments who are engaged in investigation of the complaint
These reports should be available to the regulatory and legal affairs department during GMP inspections
Market related complaints, good manufacturing practices, confirmed complaint, counterfeit suspicion, corrective and preventive action, investigation, handling complaints
