OR WAIT null SECS
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.
June 09, 2016
Sharing un-redacted inspection reports between FDA and EMA may reduce duplicate inspections of facilities.
The agency publishes three final guidance documents on drug compounding.
June 08, 2016
The agency cited KO DA Pharmaceutical Co. with cGMP violations.
June 07, 2016
There are technical hurdles to clear in developing serialization and track-and- trace programs, but it’s the human ones that are proving most difficult to surmount.
June 06, 2016
The agency reiterated its earlier decision to require suffixes in biosimilar naming, but was unclear on suffix meaning.
The agency published a report on fostering the development of advanced therapy medicinal products.
June 02, 2016
FDA and bio/pharma companies get serious about continuous manufacturing to ensure product quality.
Industry experts discuss common considerations and recent technological advancements in blow-fill-seal technology.
Investment in talent and infrastructure, more quality-by-design skills, and increased communication with global regulators will be needed to combat compliance issues at API and drug manufacturing facilities in India.
This article presents recommendations based on a program that was set up to qualify members of a large, diverse team at one oral solid-dosage-form manufacturing facility.