An Investigational Study on Factors of Quality Culture in Pharmaceutical Manufacturing Sectors

Abstract

Quality in pharmaceutical is strengthened by training of concerned employees through validated training system consistently with effective assessment mechanism. The health of Quality in the pharma industry is determined through the sites’ compliance status. Quality is maintained by the trained employees involved in the manufacture, processing, packing, or holding of the drug product in the company. Training of employees cannot be limited to company policies, standard operating procedures (SOP), standard testing procedures (STP), work instructions, or guidelines but need to be extended to those areas whose input enhances the quality approach of employees. Quality of employees enriches the way of execution and sets trends on quality. Intervention through quality culture enhances the quality of the existing system. Quality culture aligns employees to the concept of quality through a quality approach. Finally, quality culture involvement aims for better productivity.
Quality is important but criticality varies with resource allocation which was sensed by pharmaceutical companies during the Covid time. Impact of Quality Culture was studied through six factors: quality mindset, inspiration, integrity, proactivity, discipline, and accountability. An online survey was done on sixty pharmaceutical professionals from India, Switzerland, and the United States. A survey was designed to understand the strength and weaknesses of quality culture. The survey consisted of 32questionnaires with 5-points Likert scaling and routed through online mode. The survey specifically speaks on how quality culture speaks, guides, enhances, encourages, and transforms the work environment through quality insight. Descriptive analysis was performed for the data and found quality mindset dominates the list whereas accountability is least impacted by the quality culture. Overall satisfaction level for Quality Culture was found satisfactory and recorded on the higher side.