Although the aim was to identify the attitude on the usefulness of pharmaceutical process validation, a further aim was to establish whether there are differences in attitudes between European countries or the different parties.
Operationalization of the subject was done under five headings:
- How do you feel about process validation?
- What are the benefits of process validation?
- What are the negative aspects of process validation?
- How can we make process validation easier and more effective to get the most from it?
- What hinders positive thinking on process validation?
The first three questions were designed to measure the overall attitude towards process validation and the final two were mostly determined the reasons underlying the attitudes, and also attempted to find out if some specific tools of process validation were known among the participants.
The initial round started with a background information questionnaire, which also included one final question estimating the overall opinion on process validation. This questionnaire was to be completed before commencing Q1, and thus, the last question served as a control, measuring the attitude at the beginning of the study. The same question was repeated at the end of the second round questionnaire (Q2).
The Internet as an environment for the survey The WebCT (WebCT, Inc., Lynnefield, Massachusetts, USA) learning environment26 was chosen as the platform for the survey because it was already being used in Helsinki University and offered the required tools. Extranet homepages were constructed and the questionnaires, together with supporting communication tools and information pages, were available from the Internet public page. The participants were e-mailed the passwords required to access these pages.
Guidance and other information, including definitions of the critical terms, were offered on the homepages and an online forum was available for anonymous discussion. The discussion area was continuously available and an online forum was organized twice during the survey - before and after Q2. The surveys' Internet public homepage can still be viewed.