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It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.
Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.
Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. ecosystem.
July 02, 2017
The more pharma science and technology change, the more business and policy concerns stay the same.
The opening presentation gives the company a chance to put their best foot forward, according to Siegfried Schmitt, principal at PAREXEL.
FDA is working with manufacturers to encourage industry innovation.
This article presents a general strategy for authorship of deviation investigations, with primary focus on regulatory inspection success.
Russell Madsen, president, The Williamsburg Group, and member of the Pharmaceutical Technology editorial advisory board, shares his thoughts on technology innovations and regulatory implications.
Excipients play a key role in the development in emerging dosage forms but attention to quality is crucial.
Pharma company consolidation and outsourcing led to a de-emphasis of manufacturing and reduced investment in new technologies and facilities.
Cheaper drugs are good for consumers, but cost restrictions limit drug company incentives to modernize facilities.
Regulations and business changes have altered Big Pharma’s place in the industry.
Pharma’s test of continuous manufacturing is starting with oral solid-dosage forms.