Welcome to a new series of books dealing with various “Aspects in Pharmaceutical Manufacturing.” This series is intended to provide information
to those just coming into the industry, guidance for those already working in
the industry, and/or those who just want to “brush up” on their knowledge
of the various specific aspects of pharmaceutical manufacturing. Each book
in the series will be primarily designed to address the WHY and the HOW of
specific pharmaceutical aspects, for example, equipment qualification,
cleaning, and biotech—upstream and downstream operations.
Examples and references will be provided to help guide and support the
information presented. The authors were all selected because of their expertise and their ability to present this knowledge in a clear and concise manner.
Although many of the topics to be covered in this series may been seen in
other works and covered in general, each book in this series will cover one
specific aspect of the manufacturing process or environment. Reasons
behind and the methods needed to implement a compliant program for that
aspect of pharmaceutical manufacturing will be explained.
Topics in this series can fill in the gaps in the education of pharmaceutical
employees. Knowledge obtained in formal education settings often lacks in
real world conditions such as emergencies that are often encountered in
pharmaceutical or biotech manufacturing. The information provided to
the reader will help stimulate formulating compliant solutions in GMP documentation, resolving problems (getting to the root cause), and more.