Sets forth tested and proven risk management practices in drug manufacturing Risk management
is essential for safe and efficient pharmaceutical and biopharmaceutical manufacturing…

Quality risk management (QRM) is now a regulatory expectation, and it makes good business
sense. The goal of the risk assessment is to increase process understanding and deliver …

In July 2006 the Parenteral Drug Association9s Risk Management Task Force for Aseptic
Processes, conducted an electronic survey of PDA members to determine current industry …

… In addition, I would like to thank my co-editor Hal Baseman and Dr. Mike Long for their
help and mentorship. Finally, I would like to thank all contributors for their chapters. …

Form fill and seal (FFS) is a process by which a container is formed, filled with product, and
sealed in a continuous and uninterrupted manner. FFS is a process used to package sterile …

This chapter presents points to consider on the use of quality risk management and assessments
to help the reader make decisions needed to plan, develop, and conduct more effective …

The validation of the aseptic process is particularly challenging. What are the principles and
methods for planning and designing the validation of sterile parenteral solution …

One of the reasons aseptic processes are difficult to validate is that it involves trying to prove
something has not happened. Aseptic process simulations, also referred to as media fills, …

This is an introductory chapter of Risk Management Applications in Pharmaceutical and
Biopharmaceutical Manufacturing, which offers the reader multiple perspectives and …

Blow fill seal (BFS) involves the manufacture and filling of plastic containers in one continuous
operation. This chapter focuses on the fundamentals of operation and a discussion of …