Thank you for participating in the Process Validation Practices Survey. We request only one survey response from each site of any company. This is an anonymous survey and will not record any information about the respondent or whomever they represent. Output of the survey will be provided to all participants of the ISPE Statistician Forum (March 31 - April 1, 2014 in Philadelphia).

1. Does your organization have any program to monitor the process capability / process performance (Cpk / Ppk)?

2. If you answered "Yes" to Question 1, what percentage of products and processes are monitored?

3. At which stage or stages does your company monitor the process capability and / or process performance (Cpk / Ppk)?

4. How would your organization decide that the designed formulation and process are ready for scale up and technology transfer to commercial site?

5. During process qualification stage, what would be a reasonable acceptance criterion to define a qualified process?

For example: 95% lower confidence bound of Cpk >1?

6. Does your organization use Cpk / Ppk and other statistical process control (SPC) tools like control charting to monitor routine commercial manufacture?

7. If you answered "Yes" to Question 6, how are the control charts structured (cumulative or last 25 or 30 batches)? or time based (monthly, quarterly, annually)? When and how often do you re-evaluate the control limits?

8. When does your firm consider it appropriate to normalize data for process validation statistical analysis?

9. Do you have any other comments or suggestions? Additionally, please note answers (by question number) which reflect personal opinion and not an implemented practice.

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