OR WAIT null SECS
June 17, 2014
ISPE Metrics Pilot Program is designed to demonstrate the feasibility and value of standard quality metrics.
FDA provides advice to supply-chain stakeholders on how to identify suspect drug products and how to notify the agency of those products.
June 12, 2014
EMA has published a new guidance template for the qualified person’s declaration concerning GMP compliance of API manufacture. The QP declaration template provides the basis for demonstrating compliance of the API manufacture with GMP requirements and ensures that the manufacturer has sufficient knowledge on the supply chain.
Draft guidance from FDA includes information essential for the completion of ANDA applications.
June 02, 2014
In legacy facilities and as buildings age, ensuring cGMP compliance can become complex. A review of a facility's gowning operations can bring insight into the current state of cGMP compliance. The author presents characteristics to look for and questions to ask.
May 30, 2014
FDA finalizes guidance on expedited programs for new drug approvals for treatment of serious and life-threatening conditions.
May 14, 2014
Draft guidance addresses the use of clinical pharmacology studies to determine biosimilarity of biologics.
May 08, 2014
Life-sciences companies can get a jump on potential quality problems by looking at the leading indicators hiding in the document management process further upstream.
April 16, 2014
The cleaning validation lifecycle includes assessment, development, validation, and monitoring.
March 17, 2014
New injection-delivery systems with multiple closure points pose challenges for container closure integrity testing.