FDA Outlines Upcoming Regulatory Changes And Urges Industry To Be Proactive And Transparent
While reviewing upcoming changes heading industry’s way through regulatory legislations, such as the Food and Drug Administration Safety and Innovation Act (FDASIA) and the Drug Supply Chain Security Act (DSCSA), during her keynote session at Pack Expo 2014, Ricki Chase, director of investigations for the FDA’s Chicago office, urged the audience to not just focus on product integrity, but also personal and corporate integrity.
WHITE PAPERS & CASE STUDIES
Selecting Robots For Use In Pharmaceutical Manufacturing
Robots can carry out pharmaceutical manufacturing tasks faster, more consistently and more cost-effectively than manual labor.
Highlights On “Equivalent Time” F0 Sterilization
It has been experimentally shown that the reaction of thermal degradation of micro-organisms obeys the laws of a first order chemical reaction (i.e. like a chemical decomposition reaction) in which the reaction rate is proportional, in each moment, only to the amount of product still to be degraded (or decomposed).
Pharmaceutical Packaging Serialization: Evaluating Coder Technologies To Print High-Quality Alphanumeric And DataMatrix Codes
Pharmaceutical and Life Sciences/Healthcare packaging operations are held to demanding internal standards and healthcare industry requirements.
Exceeding GMP Of Medical Devices At Each Step In The Production Continuum
Through years, ATL has emerged as a leader in the manufacture of disposable medical devices. ATL is an FDA-registered medical device company whose custom disposable medical components are manufactured and shipped worldwide.
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.
A Step-by-Step Guide to Implementing An Effective Track-And-Trace Program
Although a universal standard for pharmaceutical track-and-trace solutions has yet to emerge, the California Board of Pharmacy’s ePedigree requirements are currently driving action in efforts toward implementing serialization to provide supply-chain integrity to the public. At Aphena Pharma Solutions, we have developed a step-by-step process that has helped us establish a very effective track-and-trace program.