Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) go hand in hand to maintain high safety and quality standards. GMP ensures the safety of the end user by controlling the manufacturing of the product, whereas GLP ensures the quality of the product by ensuring all activities are performed in a consistent manner. Both GMP and GLP are regulated by the US Food and Drug Administration (FDA) and affect our production of antibacterial hand soaps and hand sanitizers.
Good Labortatory Practice is a quality system of management controls that exists to guarantee the consistency, reliability, and quality of chemical tests. Following GLP ensures that when we test our products for efficacy and quality, the results are reliable and can be reproduced. This allows us to consistently check our products for any type of contamination and protect the end user from harm.
In our lab, all of our experimental procedures must be fully documented and contain all details relative to the experiment. These procedures are recorded in lab notebooks along with the results and observations of the experiment and are maintained with clear organization and individual page numbers.
A large part of GMP and GLP involves following Standard Operating Procedures (SOP), which are documents that describe how routine operations should be performed. SOP cover all routine procedures:
In order for Standard Operating Procedures to be effective, they must be comprehensive, easy to understand, and validated. SOP must be written by someone familiar with the procedure in clear, easy to follow step-by-step instructions. These procedures provide the general framework for efficient implementation and performance of all functions and activities in our facilities.
These practices also mandate that all equipment must be used for its intended purpose and kept in good, clean, working order. Before using any equipment, personnel must be properly trained and instructed on how to follow the Standard Operating Procedure involving that equipment. Additionally, regular calibration and servicing of the equipment must take place and full records of all maintenance and checks must be kept in an easily retrievable form.
In order for Standard Operating Procedures to be official, they must be validated. This means that for each and every procedure a validation protocol and report must be written and available, ensuring that the procedure is complete and accurate. Our facilities need to be validated as well, ensuring that they are suitable for the intended work.
In short, GMP and GLP exist to protect the end user from harm. These practices do this by ensuring that chemical manufacturers (like us) follow strict procedures and guidelines to control the production of certain products (like antibacterial hand soap and hand sanitizer). For our customers, this means they can count on us to provide safe, consistent, quality products and rest easy knowing that there are regulations in place to protect them.