The Biotechnology Project: The Big Picture

Biotechnology companies make products (or provide services) that must be of good quality. This document provides a simple introduction to the topic of “quality”.

A Quality Product Is One That Fulfills Its Intended Use

Everyone who has ever gone shopping knows that products may or may not be of good quality and that, as consumers, we want good quality products. What makes a good quality product? A simple definition is that quality products fulfill their intended use. Consider salt as an example. Table salt is intended for human consumption and so one of its quality requirements is that it be free of harmful contaminants. Road salt is used to keep cars from skidding and it needs to be inexpensive and of the right coarseness. Salt for the laboratory must be far more pure than table or road salt and must have consistent, documented properties. Observe that a salt product that is of good quality for one purpose might be totally unsuitable for another. Also, observe that to produce a quality product one must be able to identify and specify the characteristics that the product must have to fulfill its purpose.

How Is Quality Ensured? Quality Systems

A company that produces products (or provides services) must have a coordinated system to ensure the quality of that product. A quality system is the organizational structure, responsibilities, procedures, processes, and resources that together ensure the quality of a product or service.

When a company has a functioning quality system, it ensures that:

Tasks are done correctly, all the time, by everyone.
Products are evaluated to make sure they have been produced properly and are of good quality.
There are extensive records that demonstrate that the products were made properly and are of good quality.

The details of quality systems in different workplaces differ from one another, but there are certain elements they have in common. Of these common elements, documentation is among the most important. Documentation consists of written records that guide activities and prove what occurred. Another common element relates to resources. Every company, laboratory and facility needs resources to produce quality products. If any of these resources is missing or is unsuitable for its purpose, the final product is likely to be inadequate. Skilled personnel are among the resources critical in any organization. The employer is responsible for ensuring that: all employees have the education and training needed to perform consistently under ideal and unusual circumstances; that employees are familiar with all quality requirements pertinent to their work; that they are well-supervised; and that they receive the information, equipment, and tools to do their jobs properly.

Let’s consider more specifically the quality systems in different biotechnology workplaces: research laboratories, testing laboratories, and production facilities.

Quality In A Research Laboratory

The product of a research laboratory is knowledge of the natural world. Research scientists are unlikely to think of their work using the term “quality system”. However, research scientists do, in fact, have a long tradition of adhering informally to such a system; it is called, “doing good science”. “Doing good science” means using consistent, thoughtful and effective scientific methods; keeping honest and thorough records; verifying all results; and rigorously employing “good laboratory practices”. These practices help ensure that the research results are correct.

The quality system in research laboratories is less formalized than other quality systems; no one book spells it out. The consequences of a poor quality product are seldom life-threatening so the government seldom monitors research quality; research laboratories are not regulated as many biotechnology companies are. External oversight of research does occur when scientists publish and present their work to their peers, and when they apply for grant funding.

Life in a research laboratory is characterized by change. New and different experiments are constantly performed and procedures and ideas change depending on the results. Therefore, quality systems in research laboratories must be flexible, easily accommodating new ideas and directions. As you will see below, this easy accommodation of change and the embrace of the unexpected are not usually characteristics of quality systems in testing and production facilities.

Quality In A Testing Laboratory

In 1989 a woman was accused of murdering her baby by feeding him ethylene glycol (anti-freeze) in his bottle. The child's blood and his bottle were sent for analysis to a commercial testing laboratory and the hospital laboratory. Workers at both laboratories confirmed that there was ethylene glycol in the blood and bottle. The woman was convicted of first degree murder and sentenced to life in prison. Fortunately, two scientists became interested in the case after hearing about it on a television broadcast. The scientists proved that the child had not died of poisoning but rather because he had a rare metabolic disorder. The mother was exonerated (after serving time in prison). When the scientists investigating the case obtained the original laboratory reports, what they saw was "scary". One laboratory said that the child's blood contained ethylene glycol even though the sample did not match the profile of a known ethylene glycol standard. The second laboratory found an abnormal component in the child's blood and "just assumed it was ethylene glycol". Samples from the bottle, had not, in fact, showed evidence of anything unusual, yet, the laboratory report claimed it contained ethylene glycol! In this case, an innocent person was convicted of murder based on the erroneous statements of laboratory workers (Science: Nov. 15, 1991, p. 931).

Consider this frightening story. The product of a testing laboratory is information about samples, in this particular case, whether or not ethylene glycol was present. A good quality test result is one that can be trusted when making a decision. The consequences of a poor quality product may be life-threatening or have other serious effects. In this case, the testing laboratory provided a very poor result and the consequence was that a woman was erroneously found guilty of murder. To avoid this type of error, testing laboratories need well-run, comprehensive quality systems.

Quality systems in testing laboratories include most of what we call “doing good science” plus specific formal requirements. These requirements relate to such issues as the qualifications and training of personnel, the maintenance and performance of equipment, the facilities, methods of documentation, and the methods of performing analyses on samples. There often are books (or other written documents) that spells out these requirements. For example, clinical laboratories (which are laboratories that test samples from patients) follow the CLIA regulations (Clinical Laboratory Improvement Amendments) (these can be found at http://www.cms.hhs.gov/clia/), environmental laboratories often are governed by the Environmental Protection Agency’s requirements, and forensic laboratories follow many procedures that come from the Federal Bureau of Investigation. There are likely to be auditors who inspect the testing laboratory to make sure that a quality system is in place and is being followed.

In a testing laboratory, there are usually carefully devised instructions for carrying out tasks, called Standard Operating Procedures (SOPs), that are followed by all analysts. SOPs are critical in ensuring that everyone performs all tasks correctly, every time. There are methods in place to evaluate results to see that they are good. There are procedures for recording information about samples and results that are carefully followed by everyone. Consistency, correctness, and careful documentation are essential in ensuring that test results are trustworthy. In testing laboratories, change is tightly controlled

Quality In A Production Facility

Production facilities make tangible items. Quality systems in production facilities vary depending on the nature of the product. A poor product may or may not have life-threatening consequences. For example, some biotechnology companies make products that are used in research laboratories. These products are generally not regulated by any government agency. In contrast, the production of pharmaceutical products in the United States is tightly controlled by the Federal Government’s Food and Drug Administration.

Companies whose products are not government-regulated may choose to comply with a product quality system for business reasons. ISO 9000 is a formal product quality system that is extensive and is outlined in a series of books. According to the organization, “The ISO 9000 family is primarily concerned with ‘quality management’. This means what the organization does to fulfill:

the customer's quality requirements, and
applicable regulatory requirements, while aiming to
enhance customer satisfaction, and
achieve continual improvement of its performance in pursuit of these objectives.”

Companies comply voluntarily to improve the quality of products and to make more money. ISO 9000 was developed by the International Organization for Standardization (ISO). Oversight is by outside auditors who are paid by the company being audited.

Many biotechnology companies make medical/pharmaceutical products. A poor quality medical product can be life-threatening so these products are highly regulated by the government. The quality system used in companies that make drug and related medical products is called current Good Manufacturing Practices, cGMPs. The cGMPs have evolved within an ongoing relationship between the government (which seeks to protect the consumer) and the pharmaceutical industry. The government is represented by the Food and Drug Administration. The cGMPs constitute a quality system that has a sweeping effect in every company that produces regulated medical products. The everyday work of people in regulated companies is very much influenced by the cGMP regulations and, as a biotechnologist, you are likely to need to know about these regulations. These teaching materials relate specifically to cGMPs and related regulations

Click here for a brief history of GMP and FDA

Click here for a case study relating to a landmark event in FDA History

Click here for a role play dealing with societal issues and pharmaceutical regulations

Click here for an activity that explores the GMP Regulations on-line

To Enter the FDA’s Extensive Website, Click Here

The printable version of this document.

What is Quality? The Big Picture