The Journal of GXP Compliance
Vol. 20, Issue 3, May 2016

Tim Sandle
Certain pharmaceutical products must be sterile, including injections, ophthalmic preparations, irrigations solutions, and hemodialysis solutions. This is due to the route of administration and in relation to the intended patient population. The first paper looked at designing media fills for multiple product lines, by using a matrix; the second...
Change control electronic systems are intended to provide efficiency, cost reduction, and overall process effectiveness. Unfortunately, the industry continues to struggle with challenges such as inefficient cycle times, excessive amount of bureaucracy, quality issues, and inability to meet business needs. This document will discuss some of...
Timothy J. Fields
Outsourcing, or the use of contract service providers, has become a common practice in the pharmaceutical industry for a variety of reasons including lack of adequate in-house resources or other financial reasons. One means of controlling the quality of the outsourced product is through a contract or vendor agreement.
At IVT's 2016 Lab Week in Philadelphia, we invited top-level industry professionals to participate in a senior workshop and think tank led by Dr. Lina Patel on training in the global regulatory environment. Your editors were present at this closed door session, and we offer our readers this glimpse into executive-level thinking on this timely...
Validation Week 2021


Validated Cloud logo