publication . Conference object . 2014

Perception and application of the concept “quality by design” (QbD) by the pharmaceutical industry in Portugal

Garcia, Ana Cristina; Fernandes, Paula O.; Santos, Andreia;
Open Access English
  • Published: 01 Jan 2014
  • Country: Portugal
Abstract
The Quality by Design (QbD) paradigm states that in order to ensure predefined product quality, improve manufacturing quality performance, and serve customers’ needs one must fully understand the processes behind it. With the purpose of assessing the perception of the pharmaceutical industry in Portugal about the usefulness of a strategy for development, production optimization and control/quality management according to the QbD concept and its level of implementation, we conducted a survey amongst 28 licensed entities for the production of medicines and drug substances (excluding medicinal gases) in the Portuguese territory. This survey was applied between 16/1...
Subjects
free text keywords: Quality by design, QbD, Pharmaceutical industry, Survey, Portugal
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