To facilitate the assessment and mitigation of compliance risks associated with a third-party service organization, its services, and the systems used to provide the services, this article proposes adopting an approach from the financial sector that, with a little modification, could be used to...
Two of the contributors for the ISPE Baseline Guide: Sterile Product Manufacturing Facilities, discuss the modern technologies and break down of regulatory guidelines that will greatly assist pharmaceutical professionals and their facility...
Due to space constraints in the print copy of Pharmaceutical Engineering, the authors are unable to discuss all topics or regulatory bodies. This review highlights areas of increasing concern.
The quality of finished pharmaceutical products (FPPs) plays...
For eight years I’ve attended ISPE educational sessions across the country, from Kansas City and Saint Louis to Chicago, from Atlanta and Baltimore to San Diego and San Francisco. I’ve learned...
Amid the great opportunities that flow from extending their networks of facilities around the globe, pharmaceutical manufacturers are facing compliance challenges in emerging markets—especially culturally distinct ideas about safety, risk, and quality....
When we discussed assembling this month’s special report on sustainability, the idea of pairing it with an issue on compliance challenges was not an obvious choice. Despite those initial misgivings, the reality is that these two topics are a superb...
FDA's Regulatory Procedures Manual Provides information on internal procedures to be used in processing domestic and import regulatory and enforcement activities. While the RPM is intended mainly to provide guidance to...
The pharmaceutical, biopharmaceutical, and medical device industries have grown increasingly global in nature, a trend that will only continue. How companies sell their products around the world and share information with both internal and external...
On the morning of 3 April 2015, a fire was reported in a General Electric storage warehouse in Louisville, Kentucky. A large cloud of black smoke could be seen for miles. The building was a total loss, with the damage estimated at $110 million....
