* * * INSIGHT * * *

Summary Reports for OQ and IQ of Freeze-Dryers

by

Thomas A. Jennings, Ph.D.

ABSTRACT: The summary reports are just as important as the protocols for the IQ and OQ. Many firms expend a great deal of time and effort in preparing the protocols for the testing and performing the testing, but when it comes time to presenting the results of their efforts they often do not put their best foot forward. The summary reports is often found to be poorly organized and limited in content. Because this appears to be a common occurrence, this INSIGHT will deal mainly with the issue of preparation of Summary Reports for the IQ and OQ of a Vacuum Dryer.

This will be the last issue in this series that has examined the various aspects of the IQ and OQ of a freeze-dryer so it is only fitting that we once again call upon the staff of the Surcure  Company - Armondo, the Novice and the other supporting characters - to help us with this INSIGHT.  I hope that you have found these INSIGHTs helpful in identifying key issues concerning the validation of the freeze-dryer. It should be understood that there more to the IQ and OQ than was presented here and these INSIGHTs were designed to point out areas of major concern. In addition,  the change in the style of presenting technical information in this form I hope has been taken as a change in pace in the usual presentation of publication on a technical subject. Perhaps, it could be said that only on the Internet there is true freedom of expression where such publications have appeared.  I for one shall miss the gang at the Surcure Company; however, it has been my pleasure to introduce them to you. So let me begin to tell you the final story in this series.

Volume 3 Number 10                                                                                   October 2000

11 Pages          No  References          No Figures

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