Survey Questionnaire
1. Please indicate your job function(s) and check all that apply:
1.1. Product development
1.2. Facility, equipment and utilities
1.3. Material management
1.4. Production
1.5. Lab control and stability testing
1.6. Packaging and labeling
1.7. Supply chain management
1.8. Quality management policies decision making
1.9. Other - Please specify
2. Your company's revenues:
2.1. <$100 M
2.2. $100 - 500 M
2.3. $500 M - $1 B
2.4. $1 B - 10 B
2.5. >$10 B
3. Please indicate the relevant experience you have:
3.1. How long have you been in the industry?
3.2. How long have you been in your company?
3.3. How long have you been in your discipline?
< 1 2 – 5 5 – 10 10 – 15 > 15
Year years years years years
All subsequent questions have the following answer options:
Strongly Disagree Disagree Neutral Agree Strongly Agree
4. Regulatory Positioning Statements:
4.1. My company has a strong positive relationship with the regulators (FDA, EMA).
4.2. Agencies such as FDA and EMA are a hindrance to me getting drugs out to patients and the market.
4.3. Over the last 10 years, I see agencies relaxing how they enforce regulations.
4.4. New initiatives (ICH guidances) coming from the agencies are helping me to develop and commercialize drugs easier.
5. Implementation of ICH Guidances Statements:
5.1. ICH Q8 (Pharmaceutical Development, where Quality by Design is emphasized in Q8(R)) has been fully implemented in my company.
5.2. My company has reaped the rewards of the implementing ICH Q8 and Quality by Design.
5.3. Implementation of ICH Q8 and Quality by Design has been worthwhile.
5.4. ICH Q9 (Quality Risk Management) has been fully implemented in my company in many key areas.
5.5. ICH Q9 has helped my company prioritize work.
5.6. I feel comfortable doing nothing in areas that offer minimal risk to my products.
5.7. Implementation of risk management has become second nature to me in my job.
5.8. ICH Q10 (Pharmaceutical Quality System) has been fully integrated into my company.
5.9. I feel confident that upper management understands the issues we are dealing with to implement the new approaches described in ICH Q8-10.
5.10. I feel that the extra effort to implement the new approaches described in ICH Q8-10 has been worth the rewards.
5.11. The new guidances on process validation (FDA and EMA) have been implemented at my company.
5.12. Our technology transfer process works smoother than before after implementation of the new approaches described in ICH Q8-10.
5.13. I am relieved that we have more control in the number of batches needed to demonstrate process control to the regulators.
5.14. With implementation of the new approaches described in ICH Q8-10, my operations are more robust and rugged.
5.15. With implementation of at least some of the new approaches described in ICH Q8-10, we now have a better understanding of our processes and products so they are more predictable.
6. Change Control or Management Statements:
6.1. Our change control or management process is fast and easy to use.
6.2. People try to avoid using the system wherever possible.
6.3. We use a tiered system for changes, i.e., insignificant changes require simple approvals and more complex require deep analysis.
6.4. Our change process has a backlog of changes waiting for review.
6.5. Our change system is overly restrictive and stifles innovation.
6.6. We routinely perform post mortem analysis on our changes to see if they delivered that was promised.
7. Investigation System Statements:
7.1. We always quickly identify discrepancies and deviations.
7.2. Investigations are promptly initiated and completed in a timely fashion.
7.3. I am confident that the investigations identify the major factors responsible for the event.
7.4. I am confident that all possibilities or causes were examined for the events.
7.5. We never or almost never have repeated deviations.
7.6. I am confident that the CAPAs are directed to the real root cause.
7.7. We almost always measure the effectiveness of the CAPAs.
7.8. There are not enough resources /money allocated to deal with the CAPA
8. Document Management System Statements:
8.1. Our document management system including changing documents is run efficiently and fast.
8.2. I can get a document changed and reissued in days versus weeks or months.
8.3. Document approval gets held up often because of difficult reviewers and approvers.
8.4. People in my company tend to review in the approval cycle versus the review cycle, slowing down the process.
8.5. We have too many signatures on our documents.
8.6. We use a redline procedure because it is impossible to get documents through the system.
8.7. Our company documents are too long and very confusing.
9. Knowledge Management and Big Data Statements:
9.1. My company has well thought out strategy for knowledge management.
9.2. My company has a company-wide knowledge system available to all who need to use it.
9.3. I have all the information I need at my fingertips.
9.4. We generate lots of data but rarely use it to our advantage.
9.5. We take data and convert it to knowledge that is actionable.
9.6. I believe the term “Big Data” is just another hoax like Y2K. Nothing will change.
9.7. I think I know what "Big Data" means but I am not certain where to start.
10. Quality Metrics Statements:
10.1. FDA has talked about developing quality metrics, and I am supportive of this initiative.
10.2. I believe the FDA is headed in the right direction with respect to Quality Metrics.
10.3. Quality metrics are implemented and tracked in my company.
10.4. The quality metrics are good in my company and helpful.
10.5. Measuring the number of deviations and rewarding people who have fewer is a good strategy.
10.6. Right First Time is a good metric since it will lead to better outcomes.
10.7. A metric requiring actions to be completed in a defined timeframe (e.g. closing investigations in 30 days) improves our performance.
10.8. Metrics improve the quality of work.