Abstract

COMPLAINT HANDLING AND PRODUCT RECALL PROTOCOL AND PROCEDURES

Aroon Adulapuram, Fariya Begum*, Fariya Fatima and E. Bhavani

ABSTRACT

In the Pharmaceutical Industry, any type of immediate response to the customer can be censorious because any product failure can be death dealing situation for a customer. A Company’s force as well as its character largely depends on whether there are complaints about the Company’s marketable products. Unfortunately, not all risks are predictable, whereas some remains unpreventable, mainly because of the biological origin of these products, but also due to errors. Effective product complaint management is an essential component to ensure regulatory compliance and maintain patient trust. Complaints in the Pharmaceutical Industry can stem from various stages such as production, transportation or packaging, necessitating a comprehensive approach to complaint management. dealing with request complaints should be a major task. This critical step requires a single, unified and secure platform for managing product complains from launch to finish. Well defined procedures should be in place to handle market complaints promptly and with the highest priority. This ensures that the complaints are tracked, investigated, and resolved in a timely manner, minimizing potential risks to patients and maintaining regulatory compliance .The FDA-483 form is used to document observations made during inspection of pharmaceutical manufacturing facilities. Effective product complaint management, including swift response to customer complaints, through investigation, and compliance with regulatory requirements, is essential for ensuring patient safety and maintaining the integrity of the pharmaceutical industry.

Keywords: Product complaint, Patient trust, Investigation, Patient safety, Food and Drug Administration [FDA].