Quality assessment is one of the most crucial aspects in the pharmaceutical industry. The evaluation of quality and operational excellence of a pharmaceutical organization is an important factor which has a direct impact on the selection of prospective contract manufacturing partners. Bilcare, a prominent name in the pharma packaging industry highlights the essential factors for quality assessment in pharma industry.
Consistency and good overall structure are the factors which determine the effectiveness and working process of an organization. The management of staff and operational competence are the prime indicators of fundamental performance of the organization. The quality is directly determined by the aspect of sustainability. Robust processes ensure the consistency in quality management. The way an organization handles and resolves deviations & manages their elimination is an indicator of organizational effectiveness. Bilcare highlights the corrective and preventive actions (CAPA) which is a small process for eliminating problems. It involves identifying the problem, analyzing and determining its root cause and ensuring appropriate measures to correct it and document it efficiently. It is important to make sure that the process of CAPA should be comprehensive, correct and preventative.
The management of deviation data like the defect rate, number of lab investigations, out-of trends etc. directly affects the performance of the company. The ability to manage and mitigate risk factor through quality systems and operations is important for analyzing the operations and processes of the organization. The defect rate is the top quality metric, thus it becomes important to analyze how effectively the organization manages the defect rate.Importance of Quality Assessment in Pharma Industry
