Expectations of regulators, sponsors, and investors are met through efficient and well-designed quality systems and the implementation of a suitable development-stage. Several firms have unique ...

For breakthrough product development, Pharmaceutical Quality System (PQS) requirements need to be followed while supplying suitable flexibility to suit accelerated activities for breakthrough product ...

Recent changes to the EU Guide to GMP emphasise the importance of Senior Management involvement and commitment in the design, implementation and commitment in the design, implementation, maintenance ...

Quality metrics and more domestic production aim to avoid supply disruptions and drug shortages. Despite the pandemic, FDA has worked to maintain appropriate oversight of biopharmaceutical production ...

Lake Forest-based Hospira Inc. announced a number of new appointments to its quality and plant operations, including the appointment of Zena G. Kaufman as senior vice president, quality, effective Feb ...

Digital GMP expectations are increasing, driven by Annex 11 and Annex 22, necessitating robust lifecycle management, data ...

The first scientific papers outlining the progress made on the Product Quality Lifecycle Implementation (PQLI) initiative are being published in the June 2008 issue of the Journal of Pharmaceutical ...

In the pharmaceutical and life sciences industries, the terms Quality Assurance (QA) and Quality Control (QC) are often used interchangeably, but they represent two distinct and critical functions ...

Hospira Names Zena G. Kaufman Senior Vice President of Quality; Strengthens Quality and Compliance Capabilities With Addition of Top Industry Talent LAKE FOREST, Ill., Feb. 13, 2012 /PRNewswire/ -- ...