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

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

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


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.

Your answers

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.

To add your definition, click here.

To answer our next question, “How do you define ‘PAT’?,” click here.

 

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
35%
Breakthrough designations
12%
Protecting the supply chain
35%
Expedited reviews of drug submissions
12%
More stakeholder involvement
6%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
USP Faces New Challenges

Click here