NDLI: PAT within the QbD Framework: Real-Time End Point Detection for Powder Blends in a Compliant Environment

Content Provider	Springer Nature Link
Author	Flåten, Geir Rune Ferreira, Ana Patricia Bellamy, Luke Frake, Paul
Copyright Year	2012
Abstract	A process analytical technology (PAT) method using a near infrared (NIR) spectrometer attached to a drum blender was developed for real-time end-point detection for an extragranular blend.The method and corresponding documentation are part of the control strategy for a recently filed and approved pharmaceutical product, and the method is currently in place and in use for manufacturing of this pharmaceutical product at GlaxoSmithKline.The immediate benefits are a dramatic reduction in blend time as well as real-time verification of blend homogeneity for every batch. The development of the blending end-point method is presented and a set of fundamental requirements for developing any PAT method is proposed.It is discussed how the reported PAT end-point method fits with the proposed PAT framework, and the validation aspects required to achieve a compliant method for use in drug product manufacturing are presented.
Starting Page	38
Ending Page	45
Page Count	8
File Format	PDF
ISSN	18725120
Journal	Journal of Pharmaceutical Innovation
Volume Number	7
Issue Number	1
e-ISSN	19398042
Language	English
Publisher	Springer US
Publisher Date	2012-02-03
Publisher Place	Boston
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	QbD PAT Blend Chemometrics NIR Compliant Industrial and Production Engineering Pharmacology/Toxicology Biotechnology Biochemical Engineering
Content Type	Text
Resource Type	Article
Subject	Drug Discovery Pharmaceutical Science

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Online Monitoring of Pharmaceutical Materials Using Multiple NIR Sensors—Part II: Blend End-point Determination

QbD—Enabling Modern Product Development and Manufacturing

Evaluation of Analytical and Sampling Errors in the Prediction of the Active Pharmaceutical Ingredient Concentration in Blends From a Continuous Manufacturing Process

Synthetic Calibration for Efficient Method Development: Analysis of Tablet API Concentration by Near-Infrared Spectroscopy

Analytical Method Quality by Design for an On-Line Near-Infrared Method to Monitor Blend Potency and Uniformity

Overcoming Inherent Limits to Pharmaceutical Manufacturing Quality Performance with QbD (Quality by Design)

Online Monitoring of Pharmaceutical Materials Using Multiple NIR Sensors—Part I: Blend Homogeneity

Monitoring of High-shear Granulation using Acoustic Emission: Predicting Granule Properties

Risk-based Quality by Design (QbD): A Taguchi Perspective on the Assessment of Product Quality, and the Quantitative Linkage of Drug Product Parameters and Clinical Performance

PAT within the QbD Framework: Real-Time End Point Detection for Powder Blends in a Compliant Environment

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