NeuAge Institute (NAI)

Maximizing the Impact of Regulatory Affairs Training: A Guide to Reporting Complaints

The work that goes into developing a drug (or medical device, process, etc.) for public use is very delicate and thoroughly detailed. The safety, quality, identity, and potency of the drug, device, or process must be verified by the relevant regulatory agencies and other company/industry stakeholders. And because any observed deviation from the expected performance can prove consequential, extra care is taken to address any complaints that come up immediately.

This informs the need to create industry standards in the Complaint Reporting and Handling process. And this is so that the entire process can be properly managed to resolve the relevant complaint/s quickly. This complaint-reporting process is vital to the pharmaceutical industry’s regulatory process. With the Regulatory Affairs training program offered at the NeuAge Institute, you can equip yourself with all the relevant information and resources crucial to effective complaint reporting.

This blog provides a brief guide through the complaint reporting process in the pharmaceutical industry. 

What Is Product Complaint Reporting

The purpose of complaint reporting is to collect, investigate, and remedy complaints regarding product safety, identity, potency, quality, and purity in the market or development. Many pharmaceutical companies create a Product Quality Complaint program to handle issues of quality assurance and customer satisfaction. And professional training institutes such as NAI offer a regulatory affairs certificate to those who complete a rigorous regulatory affairs training program. 

Regulatory affairs professional meets a pharmaceutical company representative after regulatory affairs training
Product complaint reporting is part of your regulatory affairs training at NAI

Pharmaceutical professionals use their acquired knowledge and practical experience to become experts in the regulatory industry. Their work requires them to address any areas of concern raised by the product’s users, its developers, industry sources, or the relevant regulatory agencies. Ultimately, the required corrections and product quality improvements are made to ensure the products comply with the requisite industry and regulatory standards.

Regulatory Affairs Career: Product Complaint Reporting

Certain guidelines must be followed in handling every pharmaceutical company’s product complaint reporting process. This is so that the necessary corrective actions and product improvements can be made and the results monitored and validated by the relevant authorities.

If you fancy a regulatory affairs career, you should know these guidelines. Below is a short guide through this complaint reporting process as part of the product complaint lifecycle. 

Step 1: Complaint Receipt and Processing

Receive the complaint verbally, written, or electronically from patients, healthcare practitioners, regulatory bodies, pharmaceutical professionals, distribution or market sources, etc. Then log the complaint in the complaint register with information such as the complainant’s name and reference, receipt date, and complaint details—product name, batch number, all included.

Regulatory affairs professional examines a written complaint after regulatory affairs training
Knowledge of product complaint reporting guidelines is needed for a regulatory affairs certificate

Step 2: Preliminary Assessment 

Retrieve the Product Sample (if possible) or control sample to check and verify the nature of the complaint. An initial investigation into product complaints follows this to allow for the categorization and classification of complaints into “Critical,” “Major,” or “Minor” classes—according to risk and impact level. You can notify the regulatory agencies or internal Quality Control and/or Quality Assurance department. 

Step 3: Complete the investigation and CAPA

Begin a complete and more thorough investigation into the root cause of product complaints according to internal and standard operating procedures. Follow it up with Risk Assessment and development of CAPA (Corrective and Preventive Action) to forestall future complaints and enable continuous product improvement. 

Step 4: Closure 

Closure of the complaint happens after successful CAPA implementation, having gained the appropriate regulatory clearance, and receiving positive customer feedback.  

Step 5: Trend Reporting

Trend Reporting to track any changes in the benefit-risk analysis and performance of the product. This is after intensive monitoring of the frequency of non-serious incidents arising from product use. 

Are you interested in pursuing regulatory affairs training

Contact NeuAge Institute to begin your journey. 

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