Editor's Note - ISTB 128 Sets Industry Safety Standard
Robin Nozick wrote an article for the June issue of GxP Lifeline in which she erroneously referenced an unpublished version of the "ISBT Guidelines for Validation and Maintaining a Validated State in Blood Banking." Ms. Nozick regrets this mistake.
MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.