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

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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.


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