Is PAT a Silver Bullet?
Ready to kill some werewolves? Process analytical technologies (PAT) are beginning to inject quality-by-design (QbD), model-predictive control, risk management and other well-known process control methods into long-resistant pharmaceutical applications
Drying Requires Functional Model
A brief look at how PAT methods are being applied to better understand and characterize the pharmaceutical drying process.
PAT Session: Optimizing the Analyzer
Walter Henslee of Dow Chemical discusses the importance of human interaction with process analyzers in PAT.
Quality by Design in the Design Space
Process Analytical Technology (PAT) facilitates the implementation of Quality by Design (QbD). It is a system approach that defines the desired product performance. According to Ms. Chi-wan Chen, Director of the Office of New Drug Quality Assessment, CDER/FDA, QbD is an opportunity to identify the products important attributes leading to a quality product.
IFPAC Pre-Conference: Roadmap for PAT
A relative whos who in the world of Process Analytical Technology (PAT) gathered for a roundtable discussion at an IFPAC pre-conference in Baltimore, Maryland.
Is Your Marketing Reaching the Right Sales Target?
Heres some info on what Pharmaceutical Manufacturing is doing for Pittcon and in the PAT and Quality by Design areas.
Partnership to Develop Bioreactor Models
Walt Boyes, editor-in-chief of Control, discusses with Scott Broadley and Terry Blevins the partnership to test bioreactor modeling techniques and tools for the (PAT) initiative.
Lubrizol, Emerson Redefining Collaboration
Walt Boyes, editor in chief of Control, chats with Lubrizol's Bob Wojewodka and Philippe Moro, along with Emerson's Terry Blevins, on their project to embed batch process analytics into the control system to enable batch repairs.
Baxter Healthcare, Inc., Guayama, Puerto Rico:
Performance and Profitability with Advanced Control
Baxter Pharmaceutical, Guayama, Puerto Rico, optimizes its batch process with embedded DeltaV model predictive control. (11:55 minutes)
Find out what users in the process industries have to say about how and where Process Analyzer Technology (PAT) finds a place in their operations. A recent Control survey indicates that users often first use PAT to help meet regulatory requirements and then find multiple other uses for it. At the same time, in spite of many single instances of PAT technology across an operation, surprisingly few of those surveyed have a systematic, global PAT program in place. To see the complete results of our Marketing Intelligence Report on PAT, watch this video.
Application of PAT in Product Development
An Interphex 2008 Presentation by Trish Benton -Broadley-James, Terry Blevins, Michael Boudreau Emerson Process Management and Yang Zhang University of Texas.
First steps to address PAT innitiative
The PAT and Quality Improvement Library
Quality by Design describes a system in which quality is designed into a product (in this case, a pharmaceutical) rather than being tested in after production. The concept of quality by design requires the use of statistic methods and analytics (including the tools collectively known as Process Analytical Technologies) to gain understanding of processes, which can be used to optimize and control them.
Laws and Guidances
- 21CFR Part 210, 211
- CGMPs for the 21st Century
- PAT Framework
- ICH Q8
- "Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance" at http://www.fda.gov/cder/guidance/6419fnl.htm
- "A Risk-Based Approach to Pharmaceutical Current Good Manufacturing Practices (cGMP) for the 21st Century" at http://www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm