Process validation continues to be a topic of much debate and confusion
for biopharmaceutical manufacturers. It is usually perceived
as a regulatory requirement and good business practice, since it can
prevent failed batches when based on science and risk assessments.
This book provides insights into the key aspects and current practices
of process validation.
Chapter 1 addresses some of the current process validation concerns.
In Chapter 2, the use of a risk assessment method (failure
modes and effect analysis [FMEA]) is presented as a means to
prioritize process parameters for further process characterization
prior to validation. FMEA provides a logical approach that can aid
in establishing critical parameters and ensure process robustness.
Specific examples on the use of FMEA will aid readers to establish
this method in their own organizations.