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
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
23%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
7%
All of the above.
47%
No government involvement in patient treatment or drug development.
9%
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: Pharmaceutical Technology,
Click here