Statistics doesn’t have to be scary! Proper data analysis techniques throughout the product lifecycle are critical in assuring robust product and processes. Applied statistics is a supporting element within the product lifecycle and essential to applying ICH Q9: Quality Risk Management and risk-based thinking. PDA created the Applied Statistics Interest Group (ASIG) to help provide guidance on the application of good data analysis techniques to manufacturing statistics.
One of ASIG’s goals is to work with other PDA interest groups to provide informative webinars. Recently, ASIG held two webinars in conjunction with the Process Validation IG and the Quality Risk Management IG on the application of good statistical techniques and analysis to the process validation lifecycle. The leaders of these interest groups intend to repeat the webinar this fall for those members outside the United States.
The ASIG held a well-attended meeting at the 2016 PDA/FDA Joint Regulatory Conference in September that featured great talks by J. Patrick Donohue, Senior Associate Scientist, Janssen, and the U.S. FDA’s Karthik Iyer. Donohue spoke about sample size justification when analyzing a large molecule drug product, while Iyer offered the FDA perspective on using statistics to analyze the stages of the process validation lifecycle.
A number of questions were raised during the webinars and at the interest group meeting:
- How are CQAs defined?
- Are normality tests overused?
- What is the importance of graphing data prior to any other analysis?
- What is the rationale for the Use of Tolerance intervals?
- Why are some statistical tools used for Process Performance Qualification (PPQ) and not others?
- What is the rationale for an objective criteria for sample size selection for drug product PPQ?
- How do we assure the integrity of our data? After all, data is coming out of the system into statistical packages then presented in reports.
- How do we rightsize our data analysis not just for PPQ but for other quality system elements?
To discuss these questions, visit the Applied Statistics Interest Group Forum on PDA ConnectSM and continue the conversation!
Future projects include technical reports on continuous process verification and PPQ data analysis techniques and a joint meeting with the Process Validation IG at the 2017 PDA Annual Meeting. The group also plans to continue working with other IGs on areas of mutual interest.