The Quality Assurance department is accountable that products being distributed for consumption are of good quality and have been manufactured in compliance with the GMP guidelines. 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.
Complaint means that something is not right or the product is defective. For pharmaceutical companies, the GMP complaints are mainly confined to quality of a product, but it may also be about improper packaging, like ‘the blister is not labeled clearly’, ‘one tablet is missing in the strip’ or wrong labeling.
Following you find the key steps for an effective complaint handling system.
You should have open channels with regulators and customers to receive as much information as possible about how your product is doing in the market. Some will give their suggestions and advice; but others may have doubts and complaints. Today the companies generally use toll-free numbers, e-mails and chat rooms to be directly in touch with the customers.
Whatever the source and medium of GMP complaints is, you must investigate the complaint, ideally by appointing a special and trained staff to receive these complaints with all the original details. This complaint group normally sits in the Quality Assurance department. The staff appointed to receive complaints should obtain the information about the complainant and the product alleged to be defective (product name, batch number, dates of manufacturing and expiry). If possible, ask the customer to send that defective piece to you via post.
If possible feedback to the complainant how his GMP complaint will be processed and what possible steps may be taken to address the issue.
This is a real challenge. The quality assurance unit can start their work once it receives the investigation form containing all the details. They investigate a GMP Complaint in two stages: 1- Document Analysis and, 2- Laboratory Investigation.
The QA team first checks into previous records if any complaint has been reported in the same lot and how the department has responded to them. If not, check the batch records to verify if there was any deviation observed during manufacturing of the lot.
Further, the defective product obtained from the customer undergoes lab analysis. Now the quality control department analyzes the complaint sample and the sample it had retained from that batch. In case the customer doesn’t send the sample he complained about, QC will carry out the tests only for retained sample and give its conclusion.
For specifically carrying out the technical investigations, the QC department should appoint a Complaint officer. Ensure that you are giving this responsibility to someone knowledgeable in quality analysis and production.
If the complaint sample as well as retained sample, both show deviation from the specifications, the GMP complaint is confirmed. When only the complaint sample is out-of specifications and the deviation doesn’t relate to any error in the manufacturing process, it will be considered a non-confirmed complaint. In non-confirmed cases, the complaint may be due to misuse, improper handling or inappropriate storage conditions like temperature, light, humidity, etc. The complaint investigation is generally completed within a month of GMP complaint being registered.
Each confirmed case should be reported to the health authorities and corrective actions must be taken without any delay. The measures can be as simple as re-training staff members to as complex as recalling the product from the market. Check the samples from other batches to see if the problem is evident in them as well.
A confirmed quality problem puts the life of consumers at risk. So making an announcement to stop the consumption of that drug is absolutely necessary. Designate a responsible person to execute and co-ordinate the recalling process urgently, and provide him with sufficient staff and authority to complete the task at the earliest.
Write a response letter to the customer who initially reported the GMP complaint telling him how you investigated the matter, the findings, implications and the corrective measures you have taken. Along with the letter you may provide a replacement product.