GMPs

Jul 02, 2017
Pharmaceutical Technology
The author reviews key technological expectations of EU GMP inspectors on the integrity of e-records.
Jul 02, 2017
Pharmaceutical Technology
FDA’s process validation guidance has evolved and the current lifecycle approach has profoundly influenced validation practice.
Jul 02, 2017
Pharmaceutical Technology
Pharma’s test of continuous manufacturing is starting with oral solid-dosage forms.
Jul 02, 2017
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Excipients play a key role in the development in emerging dosage forms but attention to quality is crucial.
Jul 02, 2017
Pharmaceutical Technology
This article presents a general strategy for authorship of deviation investigations, with primary focus on regulatory inspection success.
Jul 02, 2017
Pharmaceutical Technology
FDA is working with manufacturers to encourage industry innovation.
Jul 02, 2017
Pharmaceutical Technology
The opening presentation gives the company a chance to put their best foot forward, according to Siegfried Schmitt, principal at PAREXEL.
Jul 02, 2017
Pharmaceutical Technology
Real-time alternatives to dissolution testing are required for continuous manufacturing to reach mainstream use.
Jul 02, 2017
Pharmaceutical Technology
CDER’s Janet Woodcock endorses modern drug manufacturing to ensure access to safe and reliable medicines.
Jun 29, 2017
By Pharmaceutical Technology Editors
The agency determined additional guidance was needed to reduce regulatory compliance burden.
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