Written by an expert for those who must design validatable cleaning
processes and then validate those processes, this book discusses
interdependent topics from various technical areas and disciplines.
It shows how each piece of the cleaning process fits into the
validation program, making it more defensible in both internal
quality audits and external regulatory audits. Designed for use in
the overall validation program, the book demonstrates how to build
a comprehensive program, and includes discussion and examples of
cleaning systems, regulatory requirements, and special topics and
issues. It provides an FDA cleaning validation guidance document
and a comprehensive glossary.
General
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