Books by LearningPlus founder James L. Vesper

Quality and GMP Auditing Clear and Simple

This book provides you with both a deep understanding of the principles of GMP auditing and the techniques to apply them to your organization in ways that will allow you to meet and exceed GMP requirements.

An experienced trainer, Jim Vesper uses a building block approach to cover topics related to the four key competencies essential for successful GMP audits and to break down the audit cycle into five distinct phases. Using proven techniques, he then offers you a dozen audit approaches that you can adapt to your specific requirements.

Written for QA/QC professionals and others interested in audit basics, this book is a hands-on learning tool that will enhance your audit techniques and provide you with a deeper understanding of ways to meet the demands of the regulated environment.

Preface

The roots of this book extend back to the experiences and on-the-job training I had in the corporate Quality Assurance Division at Eli Lilly and Company. There, I had the opportunity of learning good manufacturing practice and quality auditing techniques from experienced colleagues. In the U.S., and overseas, I was able to apply these skills as we audited manufacturing and support sites.

The more recent catalyst for this book was being asked to create a workshop to teach auditing skills to pharmaceutical industry personnel. In designing the workshop, I talked with experienced auditors as well as auditees. I tried to understand the thought process used by auditors-something expert auditors do not consciously ponder; they simply audit.

Nobody is born an auditor --  it requires basic knowledge and several different skill sets. To be a successful auditor, you need to:

• Have technical and regulatory knowledge and be able to apply it in various situations;

• Organize your thoughts and actions, following a defined process;

• Communicate effectively orally and in writing; and

• Work well with people.

This book is written for someone who is new to GMP auditing; it covers topics related to these four competencies, which will help make you successful. You will find the rationale for why auditing is an important quality tool, along with the audit cycle broken into five distinct phases. The basic framework for auditing (the phases of preparation, conducting the audit, reporting, following-up) can be found in almost any book on the ISO 9000 quality system; in this book an additional phase, on analysis, is included.

Two other pieces that have been added are the Types of Audit and Audit Approaches. These are meant to give more structure to the questions, "What is the purpose of this audit?" and "What should I be looking for?" The categories and items presented in the Type of Audits and Audit Approaches are not meant to be definitive. They are guides that should be expanded upon as needed and kept current.

In Appendix 2, in the back of the book, are responses to a questionnaire from experienced auditors. Their personal insights are valuable for new auditors and will trigger memories for those who have been auditing for many years.

While this book is aimed at personnel new to GMP auditing, many of the concepts can be used in other areas. For example, currently, as I create GMP training programs and courses for clients, I do not formally audit firms. Instead, other training professionals and I conduct a needs analysis to define desired performance; examine actual performance; and identify the knowledge, skills, and performance tools/support that people need to do their jobs. This process has many elements in common with auditing; a background in GMP auditing has made this immensely easier for me.

To be successful at auditing you need more than this book-you need to audit. Working with other experienced auditors will help you apply the information from this book and allow you to develop the skills and instincts you need. Do not be alarmed if the seasoned auditor you work with doesn't have a detailed audit plan written up or a loose-leaf binder filled with checklists. When you have done dozens of audits every year for a decade, you may not need them either. Early in your career as an auditor, however, plans and checklists are tools you need to use and continually refine. You will find that the tools will not only help you audit, but will increase your professionalism and credibility with the audit sponsor and the auditee.

GMP auditing is a tremendous way to learn more about the drug and medical device industry. It also is important from the consumer/patient side. Every time you audit, you help assure that the products our families might use are safe, properly identified, pure, and of the highest possible quality. Please do a good job. We're depending on you.

Jim Vesper
May 1997

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