Quality Management System for Active pharmaceutical

Quality Management System - integrating GMP into ISOA well trained workforce is likely to be better motivated, more efficient, and less likely to makeexpensive mistakes. As competency requirements change and evolve, an efficient trainingsystem is an invaluable contribution to any company’s competitive edge and overall success.Experience in a variety of industries has confirmed the value of an EN-ISO 9001 based QMSas a firm foundation for progressing to world class status as exemplified by achievement of theEuropean Quality Award and equivalent. It also provides a suitable springboard for developingan Integrated Management System incorporating quality, safety and environment.Regulatory Compliance and (Continuous) Inspection ReadinessIt is common for a company to commit a vast number of costly man-hours, and expose staff tothe associated stress and disruption, in preparing for inspection by a regulatory authority.Because such inspections look for evidence of GMP compliance, the ability to demonstrateeffective control through a documented QMS will help demonstrate to the inspecting authoritythat all relevant aspects of product quality have been addressed.Since many GMP deficiencies are the result of a weakness in, or failure of, part of the QMS, aneffective internal quality audit system will go a long way towards ensuring regulatorycompliance, and will facilitate continuous inspection readiness.Recognised Best PracticeCompliance with this internationally recognised business standard for managing quality,whether through third party certification or a less formal in-house approach, will providevisible evidence to regulatory authorities, customers, and staff alike that a company’s processesare under control. The strong emphasis on forward planning will minimise expensive qualityfailures. A realistic practical balance between the level of documented procedures, training,qualifications, and experience will ensure a minimum of bureaucracy. The level ofdocumentation should not exceed that required to maintain the desired level of quality.Reduced StressA concisely documented QMS, having the full visible support of top management, will lead tobetter understanding of employee roles, responsibilities, authorities, and working interfaces. Itwill avoid confusion, and reduce the risk of omission and /or duplication. Less staff time will beabsorbed by fire-fighting and crisis management, allowing more time to be devoted toimproving operating efficiency.64