PREFACE

This book was written to provide examples of detailed qualification protocols to   engineers and scientists working in the pharmaceutical industry. As a part of validation activities, qualification is an essential requirement for GMP (Good Manufacturing Practice) plants to manufacture pharmaceuticals or medical devices when the plants or their systems are newly built or renovated. It consists of DQ (Design Qualification), IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification). When a validation project is planned, it is much easier for validation engineers to prepare the work if examples of protocols are available in-house. When there are no such examples available, the validation engineers will have to spend quite some time and effort to develop the protocols from scratch. Therefore, good examples of protocols are always desirable. However, books introducing such detailed examples are rare, even though there are many books describing the general principles of validation.

One of the reasons for the lack of such examples would be that, once printed, it is difficult to keep the protocols up-to-date to satisfy the requirements of cGMP (current Good Manufacturing Practice) which is by its nature changing continuously to reflect the current FDA requirements along with the recent scientific and technological advancements. Another reason could be that it is not possible to list every detail of the protocols in a book because they are normally quite lengthy.

In order to resolve such difficulties, this book was written as a digital book to be available on the internet. With a digital book, the text of the book can be revised as frequently as necessary, so the example protocols can be maintained up-to-date easily. Furthermore, since there is almost no volume limitation with a digital book, it is possible to provide comprehensive illustrations of validation protocols. It is, however, expected that the validation engineers will adapt the example protocols of this book to the specific service conditions of their plants. Our wish is that this book would benefit validation engineers in finding examples of detailed qualification protocols readily.

This book was prepared based on thirty five years of our experience with  organic synthesis plants, biotechnology plants and medical device plants in plant design, validation and consulting. During our career, we have had innumerable opportunities to share knowledge on GMP plant design and validation with our colleagues, equipment suppliers, construction companies and regulatory officials of various nations around the world. Without the close exchange of knowledge with them, this book would not have been possible. We want to express our sincere thanks to all of them. We also want to express our gratitude to our families for providing us with limitless support while this book was written.

Peter Byonghyock Choi, Ph.D., P.E.  
PLANTVALIDATION.COM
Wayne, Pennsylvania