Recent Warning Letters: Review for Preparation of an Aseptic Processing Inspection

The focus of this book is to provide a way to prepare for a FDA inspection of an aseptic facility by reviewing Warning Letters recently issued to pharmaceutical companies. The number of Warning Letters issued by FDA has been rising in recent years. The FDA publishes Warning Letters in its Electronic Reading Room available on its website. The problem is that it takes time to download and review the documents and look at them cohesively for their impact on your operation. This book has taken these observations and segregated them according to the applicable GMP requirements, making them easier to look at in a systematic fashion. Based upon lengthy industry experience, Jeanne Moldenhauer has done the work for you by reviewing all relevant recent Warning Letters for aseptic processing topics and has identified areas of focus and interest for investigators, some of the types of issues deemed important by the investigator, and potential issues that may be applicable at an aseptic processing site.