1: Introduction to Biotechnology and Quality Assurance
- Page ID
- 39476
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Objectives
- Define Biotechnology
- Describe the responsibilities of departments in a biotechnology company
- Distinguish between quality assurance and quality control job functions
- Discuss quality as it relates to the customer
- Understand the basis for the importance of quality in a company
- 1.1: Introduction to Biotechnology
- According to the United Nations Convention on Biological Diversity, biotechnology is “any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for a specific use." The concept of “specific use” typically involves a commercial application or benefit to humanity. Genetic engineering, artificial selection, antibiotic production, and cell culture are current topics of study in biotechnology.
- 1.2: Modern Applications to Biotechnology
- Recent advances in biotechnology are helping us prepare for and meet society’s most pressing challenges. According to the FDA, there are over 19,000 prescription drug products approved for marketing. More than 13.3 million farmers around the world use agricultural biotechnology to increase yields, prevent damage from insects and pests, and reduce farming's impact on the environment.
- 1.3: The Structure of a Biotechnology Company
- A typical biotechnology company will employ an array of people with credentials and experience in these disciplines. These scientists and technicians may work in a laboratory setting performing research while others may lend their expertise to other departments such as Production, Quality Control, or even Marketing. The type and number of specialized departments within a biotechnology company, as well as the way talent is distributed across them, depends on the type of company it is.
- 1.4: How is Quality Involved Company-Wide?
- A quality product is the result of a quality company involving every member of the company from the shipping and receiving, to marketing, in addition to any of the wet-lab job duties. This section address a summary of Total Quality Management in a company.
- 1.5: An Introduction to Quality
- For businesses to succeed in such a competitive and demanding market, they need to formulate a way to do what they do faster, better, and cheaper than the competition. Their survival depends on it. Understanding quality and quality systems are what can give businesses the edge they need to succeed and compete.
- 1.6: Quality Principles
- Most quality systems are based on the marriage of two main quality principles; Total Quality Management and Continuous Improvement. Meaning, the customer determines quality specifications, everyone in the company is responsible for product quality, and there is a formal process to continually improve the processes to ensure quality products.
- 1.7: Quality Systems and Approaches
- Many companies follow quality systems and standards to help them meet the needs of the customer. We will go in-depth into the quality methodologies, which are important in the biosciences in a later chapter. Below is a brief mention of some common quality methodologies found in biomanufacturing. We will explore why a company would take on additional quality systems beyond what is required by law!
- 1.8: Quality (Professional) Organizations
- There are prominent quality professional organizations of note, such as ASQ and RAPS. Quality organizations help regulatory professionals stay connected to professional development opportunities and certifications so they may stay current in a rapidly changing regulatory landscape.