About the book:
Every Topic has Theoretical
and practical aspects. This books is solely concerned with the practical
aspects of cGMP compliance auditing. Its purpose is to provide a “hands-on”
approach for performing audits-what questions to ask and what answers to
expect.
The amount of verbiage has
deliberately been kept to a minimum. The purpose of any prose is to supplement the
checklists by explaining how to use them and how to determine whether response
are satisfactory. Otherwise information is supplied in the form of instructions
as to what to do and how to do it. The detailed checklists are intended to be
used in the audit for recording information and are maintained afterwards as
documentation of the audit.
This work is intended to
supplement existing works on the same subject, covering areas that have been
dealt with only at a theoretical or superficial level to date. After reading the book and following the
instructions, you should be able to enter with confidence any department in
your company or in any other company and perform an in-depth, effective, and
efficient cGMP compliance audit. |
