Lab Manual Introduction to Biotechnology

Regardless if you work at a biotechnology company or in an academic research lab, keeping a lab notebook is a requirement. The Food and Drug Administration’s (FDA) handbook states, “if it isn’t written down, it wasn’t done.” The lab notebook is considered a legal document and can be used in court to settle patent disputes or to report a specialist’s finding in paternity suits or criminal cases. Often times, the lab notebook is used as a starting point for other scientists who work in the lab. Lab notebooks are always maintained for the following reasons:

• To record the steps an individual has carried out and to document their observations
• To establish ownership in case of a patent dispute or other legal issues
• To establish guidelines used to evaluate the process in which a product was made and to evaluate the product itself
• To follow the production of a product through the manufacturing process
• To create a contract between a company and consumers and/or between a company and regulatory agencies
• To demonstrate a procedure was done correctly
• To develop, follow, and evaluate standard operating procedures (SOP)

Without documentation, even quality work is worthless. In the event of an experiment failing, the documentation allows for a scientist to review their protocol and make adjustments for future experiments. As stated above, in industry, lab notebooks are legal documents. They are used to determine product quality, patent rights, and liability. Notebooks are always treated as if they will be used in court because the consequences of not doing so could be devastating to a company.

Part I: Setting Up a Legal Scientific Notebook

A notebook should contain what equipment and materials were used and what steps were followed to show that the equipment and materials were validated before use. In case of an audit by government regulatory agencies, a company must be able to produce documentation that proves that they are following Good Manufacturing Practices (GMPs). If they find that a notebook was missing information or was not legible, then the company may be fined or held liable for damages in a product lawsuit. The importance of a well kept notebook cannot be emphasized enough.

Guidelines for Setting Up a Legal Scientific Notebook

*For the purpose of this course, pages suitable for a lab notebook are included in the appendix. Your instructor may direct you to print a specific number of pages and bind them with staples along the long left edge to serve as a low-cost substitute for an official bound notebook.

1. Obtain a bound notebook, such as a composition book. Spiral notebooks are not acceptable.
2. Use only blue or black pen to make entries. NO PENCIL ALLOWED.
3. Label the outside of your notebook with the information