Good Manufacturing Practices

“Good Manufacturing Practices” (GMPs) is a term describing a body of regulations promulgated by the Food and Drug Administration (FDA).  These are listed in the Code of Federal Regulations under part 21; they are numerous, extensive, and complex.  As a result, there exists a myriad of very similar definitions which attempt to describe the entirety of these regulations in a concise form.  For this discussion, the following may serve as a simplistic version:

GMPs provide for systems implemented to ensure production of food, drugs, etc. that meet minimum standards for safety with risk mitigation.

The term “GxP” (the “x” can stand for any process) has been adopted by other non-FDA-regulated industries (and other countries) to describe similar methodologies employed to ensure high-quality products which meet industry-accepted or accredited standards.  To be sure, the simplistic definition above can be adopted for production of an endless list of goods and services by merely substituting appropriately for “food, drugs, etc.” and / or “safety with risk mitigation”.

A good Consulting GMP Expert will provide your production facility with appropriate systems to assure proper Design, Monitoring, and Control of Manufacturing Processes.  This should include items such as Personnel, Plant (and Grounds), Appropriate Operations, Facilities (and Controls), Equipment, Processes (and Controls), Logistics (Warehousing and Distribution), and Defects.  Depending on the industry and processes, there may be numerous other factors which should be considered.

When selecting a Consulting GMP Expert, you should seek out an individual who has practical operating experience in your specific area.  Also, that person should be credentialed by appropriate industry or governmental agencies.  Ideally, your expert should have had managerial experience for quality and regulatory teams so he/she understands the intricacies involved in executing enterprise-wide GMP programs.  For example, in Food:  an ideal candidate would be an SQF-certified Auditor (or other GFSI scheme), hold an FDA PCQI Certificate, and have been responsible at the Director-level (at least) for Quality and Regulatory programs in an operating Food-production facility.

Large renewable energy and biochemical consulting firms will certainly have experts in more common areas like biofuels, biomaterials, biomass, biomass power, bio-based chemicals, biotechnologies and renewable fuels and chemicals in general.  Energy consultants should be willing to discuss client’s initial questions about renewable energy sources, the types of biofuels, biofuel companies, synthetic biology, the fermentation process, biomass renewable energy, biofuel energy, conversion technologies for things like tires and railroad ties, and about the circular economy in general.  These clean energy experts would optimally be part of a larger, multidisciplinary group of green energy consultants with a wide variety of expertise in more specialized areas like biomass production, financial due diligence, organic synthesis, fuel additives, ethanol gas, biodiesel fuel including algae biofuels, solid state and industrial fermentation, green energy grants, ag biotech, agricultural waste, alcohol fuels, alternative proteins and animal-free products, sustainable foods, beverage fermentation, , biocatalysis, biodiesel conversion, biogas production, biomass power, carbon intensity, co2 utilization, combined heat & power, Fischer-Tropsch technology, food waste, hydrothermal carbonization, industrial enzymes, landfill management, microbial fermentation, organic synthesis, plastic pyrolysis, plastic recycling, plastic waste, pyrolysis oil, reactor design, renewable identification number, the Renewable Fuel Standard (rfs2), solid recovered fuels, torrefaction and torrefied biomass, waste to energy, and waste-to-hydrogen.  Finally, members and strategic partners of these green energy consulting firms should also  have the availability to do things like engineering, technical feasibility studies and techno-economic analysis, due diligence, and feasibility studies, and provide expert witness testimony, and should have the contacts to assist with renewable energy finance, accounting, plant safety and insurance, legal, and virtually any other services related to the bioeconomy.

Lee Enterprises Consulting is the world’s premier bioeconomy consulting group, with over 150 highly qualified experts serving Good Manufacturing Practices and many other areas.  Take a look at our experts and the services we provide and you will see that we have just the right expert for any clean energy project.  Most of our experts are also available to advise and serve as expert witnesses in bioeconomy litigation matters.  For the larger projects, we specialize in putting together full service, interdisciplinary teams with one point of contact.  Call us at 1+ (501) 833-8511 or email us for more information.  See also:  Food Safety & Modernization Act (FSME); From the Other Side:  Biofuels Co-Products.