William N. Weaver, P.E.

Course Outline

This two-hour course provides a basic understanding of the validation process as required by the Food and Drug Administration of the United States for drugs manufactured in the United States and all imported drugs. A few applicable definitions are included as are descriptions of the process and documents required in the validation of a facility. The process of validation is explained along with the intent of the validation effort. Relationships between types of protocols and other documents which occur at the same time during the construction and startup of a pharmaceutical facility are explored. The final results of the validation process are described and how the effort is prepared for an FDA inspection is touched on.

This course includes a multiple-choice quiz at the end, which is designed to enhance the understanding of the course materials.

Learning Objective

At the conclusion of this course, the student should be able to:

• Discuss the validation process with some sense of understanding;
• Decide if he/she has an interest in pursuing further education in this area;
• Read and understand the principles within a protoco;
• Decide if work of this nature should be done in house or be contracted to an outside firm; and
• Read and approve a protocol prepared by others for his facility.
  
  

Intended Audience

Facilities engineers and management within the pharmaceutical industry.
Engineers interested in the pharmaceutical field as employees.
Engineers in consulting companies interested in moving into the validation field.
Individuals who must prepare, read, approve and/or execute protocols.

Benefits

Opening up of a growing potential job field for engineers. Removal of the mystic from the validation process. An understanding of the process and the ability to review and approve validation protocols provided by outside firms.

Course Introduction

The pharmaceutical industry is perhaps the fastest growing industry in the United States and will provide engineers with employment for many years to come. Facilities are being constructed to manufacture ever more complex compounds. The traditional organic reaction compounds are being replaced with products from the fermentation of bacteria, algae, viruses and mammalian cells.

Whether the product comes from reactors, extractors or fermenters the process falls under the scrutiny of the Food and Drug Administration (FDA). A primary rule of the FDA is that you must prove that the process you are using is under control. We satisfy that FDA requirement by validating the process.

Several States have now determined that pharmaceutical validation is an engineering activity and as such must be under the control of a professional engineer if performed by other than employees of the facility. This decision is critical and opens up new employment opportunities to the engineer. To take advantage of this opportunity you must understand the validation process.

The intent of this first course is to provide an introduction to the validation process and give the engineer enough information to aid in various validation decisions.


Course Content

Course Summary

Validation of a process is an essential activity properly performed by engineers who have training and experience with the equipment involved. Creation and execution of protocols is similar to startup and commissioning operations normally performed for any new process. The addition of testing to specifically satisfy requirements of FDA and EU officials adds some complexity.

The relationships of the various types of protocols provides a logical framework for the overall program which is to prove the process is under control. Testing in each phase of the Validation Process uses logical engineering approaches and requires engineering experience to interpret the results.

Additional Resources

http://www.fda.gov - Food and Drug Administration, FDA
http://www.ispe.com - International Society of Pharmaceutical Engineers, ISPE
http://www.pda.com - Parenteral Drug Association, PDA
http://www.ivthome.com - Institute of Validation Technology

NOTE: Entering "validation" in your web search engine will produce several million hits. Try "pharmaceutical validation". There are numerous companies offering validation, several offering seminars and training programs and a few community colleges, which teach validation theory and practice.

NOTE: There are numerous books, which cover the validation process. It is best to glance through the book before purchasing. Validation is a technique used in the electronics and computer industries as well as the pharmaceutical industry and although they share similar concepts the overall processes are not exactly the same.

Once you finish studying the above course content, you need to take a quiz to obtain the PDH credits.

Bonus Materials

The author has prepared a detailed document with the answer keys to the quiz and the reasoning behind the choice of answers. If you wish to obtain this document, please send your request to info@pdhonline.com. You need to put your name and email address in your request and put "Request K108 Bonus Materials" as Subject. We will email the document to you after you pass the quiz.