OR WAIT null SECS
May 26, 2021
ISPE’s latest guide ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry focuses on how knowledge management allows for a more effective pharmaceutical quality system.
May 21, 2021
Developing and manufacturing a therapy in a regulated environment demands careful adherence to quality practices.
May 15, 2021
Industry experts discuss how FDA’s response to COVID-19 and related pandemic-related guidance documents may impact the biologics industry long term.
May 10, 2021
The company is recalling lot EG6023 of 0.5% Bupivacaine Hydrochloride Injection, USP 30 mL and lot EG8933 of 1% Lidocaine HCl Injection, USP 30 mL because of incorrect labeling.
The company is recalling lot DN9185 of Sterile Water for Injection, USP, 100 mL Single Dose Glass Fliptop Vial because of visible particulates.
May 06, 2021
ISPE’s virtual events will center around the sustainable implementation of and shared responsibility for quality risk management, while providing a space for regulators and industry leaders to share lessons and maintain transparency.
May 03, 2021
This article introduces a practical approach to determining the best estimate for probability of passing uniformity of dosage units (content uniformity) using probability vs. lot coverage charts and tables constructed using simulated probability and lot coverage (LC1) data.
May 02, 2021
Understanding an FDA corrective and preventive actions request is step one in developing a robust plan to address CGMP deficiencies.
System documentation should include a system description, history, validation information, and references, according to Siegfried Schmitt, Vice President, Technical at Parexel.
April 21, 2021
Waters and Genovis will work to develop automated workflows for the fast and constant characterization of critical quality attributes of monoclonal antibodies and other protein-based drugs in bioprocess development, formulation, stability testing, and quality control.