Over the past several decades, pharmaceutical manufacturing has become increasingly
global and supply chains have become longer, more complex, and fragmented. While …

Abstract Between October 2020 and March 2022, FDA's Center for Drug Evaluation and
Research (CDER) completed two pilot programs to assess the quality management maturity …

The Quality Management System (QMS) implementation by Big-Grade construction
companies in Indonesia is still considered not optimum. This is evidenced by a large number …

This thesis explored knowledge management effectiveness in the pharmaceutical sector
and included an examination of the critical relationship between knowledge management …

Quality culture as an enabler of high-quality performance and subsequently as a source of
competitive advantage is increasingly discussed among operational excellence (OPEX) and …

Bu tez çalışması işletmelerin örgüt kültürü ile kalite kültürü arasındaki ilişkilerine
odaklanmaktadır. İşletmelerin örgüt kültürü ve örgüt kültürünün alt boyutları ile kalite kültürü …

In the past few years, there have been several instances of illicit pharmaceutical
manufacturing in Japan, and there is a growing awareness of the importance of corporate …

This is a study of nonconformances experienced by a laboratory of a pharmaceutical
manufacturing facility in East Africa. There has been an increase in nonconformances from …

Background PDA published its “Quality Culture Survey Report” in the PDA JPST in 2015 (1)
and presented the findings at the “Joint PDA FDA Quality Metrics Conference” that same …

Pharmaceutical quality systems according to ICH Q10 require the identification of processes
that need to be measured. Designing and maintaining a metrics system in a way that serves …