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.     

Contents:

1.      Introduction

2.      Auditing Vendors

3.      Auditing the Quality Assurance Department

4.      Auditing the production Departments

5.      Auditing the Engineering Department

6.      Auditing the Quality Control Department
7.      Auditing the Research and Development Department

8.    Auditing Contract Manufactures