FDA/Industry Perspectives: Detection, Measurement, and Control in Manufacturing - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

FDA/Industry Perspectives: Detection, Measurement, and Control in Manufacturing
The authors summarize a recent FDA–PQRI workshop on process drift.


Pharmaceutical Technology
Volume 35, Issue 10, pp. 70-74

Conclusion

Feedback obtained from FDA–PQRI workshop attendees through a post-event survey has been positive. The topic of enhancing life-cycle management of process drift should be elaborated at future workshops, including discussion of advancements and innovations in manufacturing technology that allow for dynamic process control.

Additional reading

1. PQRI–FDA Workshop on Process Drift program, http://www.pqri.org/pdfs/processdrift_finalprogram.pdf.

2. PQRI–FDA Workshop on Process Drift summary, Gold Sheet, http://www.pqri.org/workshops/ProcDrift/imagespdfs/DrugMakers_Goldsheet_article.pdf/.

Margaret M. Szymczak is an independent pharmaceutical consultant and chairperson of the Product Quality Research Institute (PQRI) Manufacturing Technical Committee. Richard L. Friedman and Rajendra Uppoor work in FDA's Center for Drug Evaluation and Research. Avraham Yacobi is an independent pharmaceutical consultant and a member of PQRI's Board of Directors.

Note: The views presented in this summary article do not necessarily reflect those of FDA or of the organizations in which the authors are employed.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

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

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
24%
Attracting a skilled workforce
30%
Obtaining/maintaining adequate financing
15%
Regulatory compliance
30%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Obama Administration Halts Attack on Medicare Drug Plans
Source: Pharmaceutical Technology,
Click here