The British Standards Institution (BSI) and the Alliance for Clinical Research Excellence and Safety (ACRES) announced a collaboration to develop global standards of excellence for clinical research sites. / read more /
FDA issued a warning letter to Zhejiang Hisun Pharmaceutical Co., Ltd., as a result of inspections that took place on March 2–7, 2015 at the Taizhou City, Zhejiang Province, API manufacturing facility. / read more /
A US district judge entered a consent decree of permanent injunction on behalf of FDA, between the United States and pharmaceutical company, Downing Labs. / read more /
FuelCell Energy plans to install a 5.6 megawatt fuel cell power generation system for Pfizer to provide reliable and low carbon electricity and steam for its 160-acre R&D facility in Groton, CT. / read more /
Next Generation HPMC Capsules Bioequivalence and Functional Performance
LIVE WEBCAST: Tuesday, January 19, 2016 at 8:00 am PST/ 10:00 am CST/ 11:00 am EST New in-vivo data demonstrating the performance characteristics of the next generation of HPMC capsules.
Register for free at www.pharmtech.com/pt/comparing
The 10-ppm criterion for the acceptable concentration of potential API in cleaning validation to minimize cross contamination into next product has been employed for many years. This article describes why the 10-ppm criterion, which was established based on analytical limitations and estimates of acceptability, is no longer necessary and why a risk-based approach should be universally adopted. / read more /
The revised USP Chapter <1207> Sterile Product Packaging—Integrity Evaluation gives best practices for obtaining reliable data in container closure integrity testing and recommends quantitative deterministic methods rather than probabilistic methods. / read more /
Liquid formulations in hard-shell capsules or softgels are becoming a popular option for HPAPIs because of advantages such as improved safety and lower risk of potential exposure and product cross contamination. / read more /
Accelerates workflow and improves analytical efficiency
Shimadzu has released the new Nexera MX ultra-fast multianalyte LC-MS system. It offers up to double the sample processing capability of the conventional approach. / Read more /
In this 60-minute webcast, experts will explain the concept of water activity and its relationship to the growth of microorganisms. Key regulatory guidance and compendial documents will be reviewed. Sponsored by Aqua Lab by Decagon
On Demand
Join Tosoh Bioscience and Semba Biosciences for a discussion on the use of high capacity protein A and hydroxyapatite resins for mAb purification using a multi-column continuous chromatography process. Sponsored by Tosoh Bioscience
A three-volume set of drug delivery system handbooks. A compilation of articles related to methods and processes of manufacturing and administering pharmaceutical compounds to achieve therapeutic effects. Topics include the development of controlled-release formulations and reformulating injectable drugs for oral delivery. / Click here /
Pharmaceutical Technology's Drug Development Application Handbook is a compilation of technical articles from the magazine's archives and application notes, technical information, and educational materials from the handbook's sponsors.
