By Stephen McIndoe BEng CEng MIET, VP Consulting, Be4ward
My previous article discussed the different aspects of technology required to support the labeling and artwork process. In this article I will look at the question of whether or not to outsource some or all of the activities involved in your labeling and artwork process.
By Jennifer Camarda, Sales Specialist, Premium Balances And Software, Sartorius Corporation
As of December 1, 2013, significant changes to the USP Chapter 41, a mandatory chapter, became effective, and now apply to all materials that must be accurately weighed. USP Chapter 41 has also been renamed, from Weights and Balances to just Balances, and it does not reference the minimum sample weight anymore, but rather, it defines repeatability and accuracy, which specifies the operating range of a balance. The operating range is limited to the maximum capacity of the balance, and begins at the point at which the balance's repeatability is less than or equal to 0.10%. The weighing must also be performed using a balance that is calibrated over its operating range.
By Uwe Amann, Harro Hüfliger Packaging Systems
In the years 1996 to 2003, the number of NMEs approved by the FDA halved, while the research expenditure in the same period almost doubled. Only roughly one in 5,000 researched substances can be developed into a new drug.
By Andrea Simonetti, Bonfiglioli Engineering SPA
This article provides the overview of the process analytical technology (PAT) methodology application to an automated equipment developed for 100 percent container closure integrity testing (CCIT) of pharmaceutical items.
By Jamie Hintlian, Ernst & Young
Limited supply chain agility increases the odds that your company will not be able to respond adequately and rapidly enough to changing market conditions or competitive moves. At best, a less reliable supply chain puts supply continuity at risk; at worst, it puts patient safety at hazard. Ernst & Young’s recent Growing Beyond survey reveals that there are clear differences in how leaders and laggards are mobilizing to address those issues.