GMPs are, in very basic terms, a method of ensuring consistency in manufacturing. They are a roadmap for quality – an instruction manual for everyone involved in the dietary supplement business. GMPs, if they are followed stringently, ensure that a product is made the same every time, with all people involved following the same steps to get the finished product. They also provide a high level of safety for the consumer, in that all aspects of manufacturing, including laboratory analysis, mixing, encapsulation, bottling, labeling, packaging, and shipping, are standardized. This minimizes the risk of mistakes in the manufacturing process that could lead, for example, to the wrong ingredients being included in a product or the wrong label being placed on a bottle.
From the GMPs, specific step-by-step instructions must be written for each and every aspect of manufacturing and must be followed by all employees involved in the process. These specific instructions are called Standard Operating Procedures (SOPs) and are one of the most important components of quality control. Lactonova Research’s SOPs have been developed over many years and are constantly being adjusted as improvements are made to manufacturing methods and quality control procedures. To illustrate the amount of detail included in our SOPs, consider this – our current GMP document consists of 60 pages; while we have more than150 SOPs (which are continually being added to and refined) that total more than a thousand pages.