Detailed Study Methodology

We employed a survey methodology using Survey Gizmo, constructing a series of questions to gather specific information related to new regulations and guidances (ICH Q8-Q11 and process validation) and their implementation.

To aid our analysis, we captured information related to job responsibility, years in the industry, company, and discipline in the survey (demographics). This allowed us to analyze responses related to discipline (quality versus non-quality roles). We also gathered information on company revenue, which aided in examining for differences in big pharma versus small start-ups and boutique operations (over $500 million and less than $500 million in revenue, respectively).

The topic sections were designed to probe perceptions by posing statements that were both positive and negative. Respondents were asked to rank the statements on a five-point Likert scale of Strongly Agree, Agree, Neutral, Disagree, and Strongly Disagree.

We approached the potential audience through the use of LinkedIn. We offered the survey (which was purposefully anonymous) through a broadcast from one of our accounts. We also broadcasted the survey via LinkedIn groups of which at least one of us was a member. The data from the survey was kept separate. Interestingly, we obtained less than 5 percent from the general broadcast versus the targeted group audience. Responses from both groups were qualitatively similar and so were combined, yielding just under 100 respondents.

We recognize that obtaining responses via this method is dependent on people’s desire to take a survey and as such cannot be a totally random demographic. It does self-select people who have a passion for the areas. That may be is why the group members were more predominant responders.

The questionnaire can be found here. The raw data for the first part of the survey is included in Table 4. We also include a breakdown for certain questions where different responses were seen for different company sizes and/or from discipline of responders. Where there was a difference between the groups, that is noted in the text. If no stratification was noted, it is not discussed. Similarly, we stratified data based on discipline (quality versus non-quality function). In these two breakdowns, we have determined by Chi-Square analysis the level of significance of the differences. Only differences observed that were statistically significant were noted in Table 5.