USP General Chapter <1207> Revisions: Industry Experts Offer Best Practices To Avoid Destructive, Unreliable Integrity Testing
In September, the US Pharmacopoeia released a proposed revision to USP General Chapter <1207> Sterile Product Package – Integrity Evaluation for public comment, which focuses on package integrity testing. This chapter is not mandated but does reflect recommended best practices. These changes are necessary to better protect not just the product but also the patient.
WHITE PAPERS & CASE STUDIES
A Case for Co-Sourcing Laboratory Services
Many industry observers believe the need for responsive, collaborative, and tech-savvy partnerships is paramount in the new emerging business environment. Success or failure in this environment will be defined by operational agility to research, adapt, produce, and deliver products rapidly under fluctuating market conditions.
Managing Laboratory Consumables
Since All I Really Need to Know I Learned in Kindergarten first appeared in 1988, its simple, profound wisdom has inspired the world. Among its easily digested messages are a few gems that research scientists would do well to employ in their labs every day: Share everything, Play fair, Put things back where you found them, CLEAN UP YOUR OWN MESS, Don't take things that aren't yours.
A New Approach To Laboratory Efficiency: On-site Instrument Concierge Service
Scientists are spending an enormous amount of their time and effort simply getting instrumentation to the point that it can be used,” the NRC reports. “This wasted time can be used more productively when a well-functioning repair and maintenance system is in place.
Pharmaceutical Company Cuts Packaging Costs
In tough economic times, First Priority, manufacturer of generic veterinary pharmaceutical products, decided it was time to take a hard look at where they could cut costs without compromising on efficiencies and quality of their products.
Don’t Get Blindsided By New USP Quality Standards
The U.S. Pharmacopeial Convention’s (USP’s) Chapter 41 minimum quality standards for weights and balances have been updated after twenty years – and every pharmaceutical manufacturer has been waiting to see what that means in practice when the standards go into effect in December 2013. By Dirk Ahlbrecht, Sartorius Group
Striving For Label Perfection In Clinical Trials
No other labeling process in the pharmaceutical industry is as complex as clinical trial labeling. Clintrak Clinical Labeling Services knows this first hand and has been committed to finding a way to reduce the amount of time and money spent on proofreading in order to improve their process.