Erik J. van Asselt, PhD, Rafik H. Bishara, Ph.D.
How long can a pharmaceutical product be exposed to temperatures
outside the recommended storage conditions? How can product discard
be prevented in cases of temperature excursions? How to establish and
to manage the allowed time out of storage of a pharmaceutical product?
The short answer is: It all depends on the chemical and physical properties
of the product, the knowledge about product stability and the presence
of temperature exposure data. In this article, the science behind the
establishment of a stability budget for products that need to be maintained
under controlled temperature conditions will be explored and guidance
will be provided to manage the product stability budget in the (bio)
pharmaceutical supply chain.
Kenneth Getz, Mary Jo Lamberti
Historically, the decision to hire contract service providers was driven in large part by the need to employ variable capacity and to gain access to scientific and geographic expertise.
George F. Klein
Many readers are familiar with the widely used method of Fourman and Mullen in setting cleaning validation/verification limits for pharmaceutical manufacturing facilities. Implicit but key to use of the method is the assumption that residues are uniformly distributed on processing equipment.
Evan M. Lazerowitz, John C. Maloney
The current regulations of the Food and Drug Administration (FDA) impose different requirements upon brand-name and generic drug manufacturers when it comes to changes in labeling to reflect newly discovered adverse effects and other drug safety information.
Gil Y. Roth
In July 2012, the U.S. Congress enacted the Food and Drug Administration Safety and Innovation Act (FDASIA), which contained the Generic Drug User Fee Amendments (GDUFA). GDUFA has noble goals in its first five year term (FY 2013 - FY 2017): improving safety, access and supply chain transparency for generic drugs in the U.S.
David Shoemaker, PhD
The Guidance for Industry: Special Protocol Assessment (SPA) was issued in May of 2002, with the express purpose of enabling the Food and Drug Administration (FDA) to provide input into the design of certain studies critical to marketing approval prior to initiation.
Scott M. Wheelwright, Ph.D.
Several years ago I led a manufacturing team that was tasked with moving protein production processes out of development and into manufacturing.
Greg Troiano, Donald Parsons, Christina Van Geen Hoven, Stephen Tuller, Jagannath Dey, Lia Brigida
Over the past couple of decades, the pharmaceutical and biotech industries have trended towards increasing outsourcing of clinical and commercial materials and services.
Andy Lee
Imagine you are working or traveling away
from your home when an emergency repair
crops up. You can’t handle it personally, but
you know someone who can – and one call to
that person takes care of it.
Harshada Sant, MS
A total of 133 NDAs were approved in 2014. This column summarizes
details on all the NDAs (New Drug Applications) approved in 2014. The
details on individual NDAs can be obtained from the articles listed in the
reference section.