The Journal of Validation Technology
Vol. 22, Issue 3, Jun 2016

Clare Leavy
Gareth Needham
Tim Sandle
This paper examines the adoption of a risk-based matrix approach for the selection of product simulations used when conducting media filling trials. Media trials are a regulatory requirement for aseptic processing manufacturers. Given that not every product combination can be assessed on multiproduct filling lines, some assessment criteria is...
An important consideration in multiproduct cleaning validation is to demonstrate that the carryover of the previously manufactured active pharmaceutical ingredient (API) into a batch of the subsequently manufactured product is below an acceptable limit. If, however, the previously manufactured API becomes therapeutically inactive during cleaning,...
Barbara Scott
The generic drug market has become increasingly competitive. The need for cheaper drugs in the American marketplace has driven the abbreviated new drug application (ANDA) submissions to staggering numbers, which in turn has lead to increasingly longer US Food and Drug Administration review and approval times.
Lynn D. Torbeck
The following key points are discussed: A data culture is characterized by an approach of questions and phrases such as “How many?” “Compared to what?” and “What gets measured gets done” Compliance professionals must develop their own skills and motivation toward a data focus Compliance professionals must work to build a culture of...
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