PharmTech Poll Results: How do you define 'design space'? - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

 Pharmaceutical Technology All results
PharmTech Poll Results: How do you define 'design space'?
 Oct 23, 2007
Untitled Document

PharmTech Poll Results: How do you define ‘design space’?

Thanks to all of you who participated in our poll! Here are a few of your answers, followed by the definition of ‘design space’ given by the FDA.

1. “The multidimensional ‘space’ is defined by the extreme combinations of all operating parameters for process, equipment, and facilities. Narrow design space by identifying critical (direct impact) or key (indirect impact) parameters on critical to quality product attributes.”

2. “The mathematical and statistical equations defining the combination of independent factor space and dependent response space from designed experiments that results in a system, product or process that consistently meets its quality characteristics with a high degree of assurance.”

3. “I think ‘design space’ is just a new buzz word for defining the acceptable range of a product and process, which is something an optimization program should have done for many years now.”

4. “The multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters associated with a high probability of the critical quality attributes all meeting specification. Mathematically, it is: Design Space={x such that Prob(Y is in S given x) is at least some acceptable reliability value}, where Y is a vector of critical quality attributes, S is a multidimensional specification region, and x is a vector of controllable process parameters. See Peterson, J. J. (2004) Journal of Quality Technology, 139-153, Figure 6.”

According to FDA

FDA defines design space in its Guidance for Industry Q8: Pharmaceutical Development, as:

“The multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters that have been demonstrated to provide assurance of quality. Working within the design space is not considered as a change. Movement out of the design space is considered to be a change and would normally initiate a regulatory postapproval change process. Design space is proposed by the applicant and is subject to regulatory assessment and approval.” The guidance is available here.

| Weekly
| Monthly
|Monthly
| Weekly
 Survey
What do you think the role of continuous (rather than batch) processes in pharmaceutical manufacturing will be over the next five years?
Many companies in the industry will be using continuous processes for some products.
Companies in both pharmaceutical and biopharmaceutical production will be evaluating continuous processes but few will implement.
Only a few companies will be evaluating or implementing; most will stay with batch processing.
Many companies in the industry will be using continuous processes for some products. 34%
Companies in both pharmaceutical and biopharmaceutical production will be evaluating continuous processes but few will implement. 29%
Only a few companies will be evaluating or implementing; most will stay with batch processing. 38%
Most Viewed Articles
 Columnists Outsourcing Outlook Eric LangerNovel Expression Systems Opening CMO Opportunities sponsored by Ingredients Insider Cynthia Challener, PhDSecuring the Global API Supply Chain Regulatory Watch Jill Wechsler FDA Focuses on Drug Appearance and Attributes European Regulatory WatcchSean MilmoEMA Collaborates with HTA Assessment Networks
 UPCOMING CONFERENCES Serialization Summit San Diego, CA Feb. 27-28, 2014 Advances in Aseptic Processing San Diego, CA Mar. 10-12, 2014 ClinTech 2014 Cambridge, MA Mar. 11-13 2014 Investigator-Initiated and Sponsored Research (IISR) Philadelphia, PA Mar. 19-20 2014 See All Conferences >>
 VALIDATION RESOURCES FROM IVT NETWORK Process Validation Special Editions 19th Annual Validation Week Compendium Computer and Software Validation Volume II Special Edition Analytical Method Validation Toolkit More from IVT