7. Investigation on the Roll Out of QbD in the Pharmaceutical Industry and the Pursued Objectives

To further investigate the current status of the roll out of QbD throughout the pharmaceutical industry, a survey was started using a questionnaire with 12 questions (see annex) as to the current status of QbD, the different approaches pursued for the roll out of a QbD driven development approach and the experiences made to date, including problems, benefits and future returns expected from this shift of paradigm in various pharmaceutical companies.

As the number of questions that could be asked using the free of charge survey by Zoomerang was limited to 12, most questions address more than one aspect of QbD and the roll out in the industry and also permit individual descriptions.

The survey was then posted at www.zoomerang.com in the internet with a link to access the survey provided in the discussion forum of the Quality by Design Group on LinkedIn⁷⁰, a professional network providing several group discussion forums for its members. Members were made aware of the survey posting via the discussion started on “QbD is not just a systematic & scientific approach to improve quality, safety and efficacy for the patient but a real competitive advantage for the industry improving efficiency and profitability!”⁷¹

This discussion was started in the forum inviting members of the group to participate in the survey via the provided link. Filling in of the web based survey could be done anonymously and was open from 9th of August 2011 till 7th of November 2011 for all members. During this time period 103 group members visited the survey but only 23 completed the full survey.

In order to increase the impact of the survey and generate more responses the survey was also sent via e-mail directly to colleagues in the pharmaceutical industry. These colleagues were invited to fill in the slightly adapted 12 questions of the questionnaire (see annex) as a web based survey on www.zoomerang.com via a separate link. This link was active from 15th of August 2011 to 7th of November 2011 and provided 16 completed surveys out of 26 invitations.

Therefore, the total number of completed surveys accounts to 39 results which were then analysed together combining both versions of the questionnaire and adjusting the calculation of responses for the slight differences between both.

Discussion of each of the questions is done in the following chapters also including individual comments provided by the responses.

⁷⁰ LinkedIn
⁷¹ Ziegler ; QbD is not just a systematic & scientific approach;.2011