Design

The following articles represent best practices in pharmaceutical product and process design, from defining input variables (such as materials attributes) to developing process parameters.

New Patterns for Quality

Quality by Design is breathing new life into quality systems and process analytical technology.

FDA Sets Its House in Order

Agency leaders are redefining science, moving away from early 20th century empiricism and toward a mechanistic understanding of processes, in everything from manufacturing to R&D and clinical trials.

Complying with ICH Q8 requires knowledge of three key spaces: design, technology and regulatory. Here's how one company used Design of Experiments to troubleshoot variability in the validation of a controlled-release pain reliever.

The Ups and Downs of Taking the Bus: Part One and Two

Wyeth's Gary Forrest discusses the challenges and benefits of implementing fieldbus technologies at a new bioprocess development facility.

An Introduction to Design of Experiments: Part I: History and Principles

This paper will introduce the corner points and concept of planning, setting up, executing and analyzing the data resulting from the DoE. In a second follow-up paper (soon to be published on PharmaManufacturing.com), attention will be paid to the special considerations of applying DoE to pharma applications.

Optimizing Design of Experiments for Fluid Bed Coating

Box-Behnken experiment facilitates process parameter selection

Reverse Quality by Design

If you can design quality into a new product and make it better, why can't you use data to re-engineer a legacy product and continuously improve its quality?

Pharmaceutical Development Case Study: "ACE Tablets"

This case study — developed by FDA, Conformia, Inc., and a working group of industry experts — is a milestone document on how to apply a science- and risk-based approach to product and process development for acetriptan ("ACE") 274 tablets, and how to document it in a knowledge-based report.

Achieving Manufacturing Process Excellence with Quality by Design, Design Space Development, Design for Manufacturing and PAT

This increased emphasis on "Quality by Design" (QbD) requires pharmaceutical manufacturers to make larger investments earlier in the product life cycle during process development in advance of approved commercial operations. The goal is to develop a sound scientific basis for a "Control Space" that accommodates a range of defined variability in the commercial process materials and operations and still produces the right product quality outcomes.

New Patterns for Quality

FDA Sets Its House in Order

Winning the Space Race

The Ups and Downs of Taking the Bus: Part One and Two

An Introduction to Design of Experiments: Part I: History and Principles

Optimizing Design of Experiments for Fluid Bed Coating

Reverse Quality by Design

Pharmaceutical Development Case Study: "ACE Tablets"

Achieving Manufacturing Process Excellence with Quality by Design, Design Space Development, Design for Manufacturing and PAT

Byrn: QbD Can Double the Number of Clinical Trials

Homing Devices May Improve Bioavailability

Deciphering ICH Q8