Perception and application of the concept “quality by design” (QbD) by the pharmaceutical industry in Portugal
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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 16/12/2014 to 1/06/2014 and had 2 groups of questions: one to characterize the industries and the other one to answer to the research objective. Data treatment and results’ analysis were made with SPSS (v.21).
Of the 12 companies that answered the survey, just one (8,3%) did not use or did not initiate the implementation of QbD, although all of them (100%) knew the concept in the context of the guidelines ICH Q8, Q9 and Q10, meaning that Portuguese industries are indeed aware of regulatory proceedings and are keeping pace towards global regulatory harmonisation. Significantly, QbD was considered of greater importance (in terms of dedicated budget and human resources) among the industries having R&D activities (p-value=0,024, assuming a significance level of 5%).
The industries’ two most used QbD tools are “Quality Risk Assessment and Quality Risk Management” (27%) followed by “Design of Experiments (DoE)” (18,9%). The most frequently pointed scopes of use and implementation of QbD are “the development and improvement of analytical methods for quality control” (28%) and “process improvements” (28%). Quality management (27,5%) and manufacturing (22,5%) are the most relevant industry sectors under these ICH guidelines’ influence.
Of the several benefits indicated as possibly achieved through QbD, the most expressive (32,1%) was “greater robustness in the final product quality and reduction of the risks of "non-compliance" and costs”. Yet, 9 responses (42,9%) stated that “inability/difficulty of allocating time and qualified staff” was the main obstacle towards implementation, followed by “uncertainties on how to actually implement the principles of QbD” (23,8%). This suggests that in spite of Portuguese industries’ ambition to succeed throughout this integrative strategy, there’s still the need to better learn the “know how” and master the skills underlying QbD. To be able to invest time and manpower might be indeed essential to go beyond theoretical knowledge and to acquire the tools and competences for approaching more efficiently this concept. In conclusion, Portuguese industries still have a long path ahead of them towards full adoption of QbD and proving its benefits. This might be done with straight cooperation of regulatory agencies (EMA, ICH, FDA) and experts of this field. However, we propose that the Portuguese academy should also participate, giving pharmacy students the awareness and competences in the use of QbD tools and concepts.
