In 2014, the members of the BioPhorum Operations Group (BPOG) produced a 100-page
continued process verification case study, entitled “Continued Process Verification: An …

Abstract “Process Validation: Practical Applications to Pharmaceutical Products” by Ira R.
Berry, Vice President-Technical Services, Pharmacaps, Inc., Elizabeth, NJ, USA. Process …

Bernard T. Loftus was director of drug manufacturing in the Food and Drug Administration
(FDA) in the 1970s, when the concept of process validation was first applied to the …

Written by experienced authorities in process validation, Process Validation in
Manufacturing of Biopharmaceuticals explores current trends in the field and strategies for …

In the present-day pharmaceutical industry the Food and Drug Administration (FDA) expects
firms to have validated manufacturing processes. Process validation has been defined as a …

A company gets a 483 warning letter, which among other things criticizes the company's
continued process verification (CPV) approach. The observations include inadequate …

In the first edition of this book, Loftus [1] focused on the factors that justify the need for the
documentation of process validation (PV). These factors included needs associated with …

Validation is an essential procedure that demonstrates that a manufacturing process
operating under defined standard conditions is capable of consistently producing a product …

Validation has been practiced within the global healthcare industry since the early 1970s.
While its exact origins are a matter of contention, during its evolution and unquestioned …

For the past decade, process validation issues ranked within the top six of Food and Drug
Administration (FDA) form 483 observation findings issued each year. This poses a …