You Can’t Have Sustainability without Good Manufacturing Practices

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David Vaillencourt
Founder & C.E.O
The GMP Collective

Good Manufacturing Practices (GMPs) are globally recognized as the minimum set of requirements that ensure products are created in a manner that are of consistent quality and safe for their intended use. Put another way - GMPs are the global standard in which we are able to ensure our planet has access to safe and reliable vaccines, drugs, foods, and natural herbal products. Guidelines exist on GMPs everywhere from the United States Code of Federal Regulations (CFR) in Title 21, various US Food and Drug Administration (FDA) guidance documents such as its Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements to the World Health Organization’s Health Products and Policy Standards website

If you are not familiar with GMPs, a quick read of NCIA’s committee blog on “Facts About Current Good Manufacturing Practices (cGMPs) And Their Role In The Cannabis Industry” is a great place to get started. Groups like the Institute of Food Technologies, the US Pharmacopeia, and of course, the World Health Organization have additional great resources that can be directly applied to the cannabis industry. For more information on why cannabis companies need to embrace GMPs, a quick Google search will pop up numerous articles such as this one. In fact, many states such as Maryland, Massachusetts, California, and Florida already require some form of GMP compliance for cannabis operators.

If you are strictly a cultivator and wondering how this will help you -- the principles of Good Agricultural and Collection Practices (GACP) are similar although a bit less stringent based on the risks and complexity to processing GMPs. The common thread of standardized processes and controls is applicable whether you are a cultivator, processor, packager, distributor, or a producer of non-plant raw materials! 


What do GMPs have to do with cannabis and sustainability?

The short answer is that GMP programs provide the framework - both the process, data aggregation, and trending to drive continuous improvement that can easily be quantified in terms of energy efficiency and other sustainability metrics. But how?

GMP "Programs" as we may want to refer to them include things like Equipment Validation, Sanitation, Environmental Monitoring, Personnel Hygiene, and more. They also require written documentation including procedures and records to support all of these programs. The procedures provide the framework in which to carry out the critical activities that need to be repeated in a consistent manner; from setting temperature and humidity parameters in cultivation and drying rooms, to gowning procedures and preventive maintenance of equipment. Written records provide the evidence that these procedures were followed, which are then periodically and systematically reviewed for anomalies, trends, and errors. The review and trending of these records enables decision making related to product quality, operational health, profitability, and yes you guessed it, sustainability!



Data Enables Informed Decision Making

So, what are you doing with those written records? Many operators file them away for compliance purposes - a legal and necessary part of the equation. But those records can tell a compelling story. They are your first line of defense when a product or system failure occurs. Was one of your grow rooms trending warmer over the last 90 days? Have you considered your preventive maintenance logs and whether a clogged filter or aging part on your HVAC system is needing replacement? The tracking and trending of this data is key to understanding and improving your operation, with the added benefit of being able to detect problems before they occur. Watch the savings quickly add up and communicate to your consumers how buying your products is good for the environment.


Sustainable Manufacturing Resources Exist

Much work has been written in the field of sustainable manufacturing. The Organization for Economic Co-operation and Development (OECD) has developed a Sustainable Manufacturing Toolkit which includes seven action items to measure your environmental performance, calculation methods on 18 OECD sustainable manufacturing indicators, and more. Download their free handbook, review your data and take their initial assessment. This toolkit is ready made for you to implement an effective sustainability program TODAY!

The expense of raw materials and their impact on the environment, from excess packaging to chemicals and nutrients being discharged into our environment are a natural byproduct of agricultural and manufacturing processes. The use of chemicals - from nutrients to extraction and purification solvents are all logged through batch records and supplier programs in a GMP system. Looking to the pharmaceutical industry, which is chemical intensive -- the necessary evil of chemistry to produce such refined active pharmaceutical ingredients has also recognized the need and value of implementing sustainability programs -- minimizing waste, decreasing their use of hazardous substances, and increasing the safety of workers and environment reduces top and bottom line costs. Even the US FDA requires an environmental assessment for all drugs as part of its New Drug Application (NDA) process as noted in a peer-reviewed research review article on emissions and discharge by the pharmaceutical industry (Velagaleti et al., 2002).


Take the first step - Benchmark

If you don’t have a GMP or Sustainability program yet today, go ahead and perform the OECD benchmark. Review your records, trending them over time to identify areas of inefficiency and opportunities for improvement. Every GMP program can be utilized to drive sustainability but consider tackling one program at a time -- perhaps one per month or per quarter. Identify one change to make, tie it to a key performance indicator (KPI) and monitor this KPI over the following months to assess the effectiveness. Rinse and repeat and watch those financial savings add up!


(1) Velagaleti, Ranga et al. “Impact of current good manufacturing practices and emission regulations and guidances on the discharge of pharmaceutical chemicals into the environment from manufacturing, use, and disposal.” Environmental health perspectives vol. 110,3 (2002): 213-20. doi:10.1289/ehp.02110213

 
 
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