Navigating Compliance: request of Fit-For-Purpose

just what is “fit-for-purpose?” Fit-for-purpose is a well established practice that is best used in several major industries, like information technology, pharmaceuticals, agriculture and inventory management. It is a concept that aligns infrastructure and systems specifications with desired outputs – be that product, service or line that is bottom. When put on a* that is( plant, its parts, products and associated processes, it can streamline regulatory framework development, implementation and compliance.

Fit-for-purpose is simply a series of logic questions you ask yourself to determine what business practices you should implement and the regulatory framework in which you must comply. What are you making? Who is it for? Where will it be sold? All this impacts how you would cultivate, process, handle and store a* that is( plant, its components and items whatever the variety of cannabis plant. The concept that is fit-for-purpose a tool that can be applied to any scenario within the cannabis/hemp marketplace. Take for instance, sustainability: a example that is practical be to develop cultivation criteria which can be “fit-for-purpose” towards the climatic area where the flowers are grown – permitting any sort of cannabis plant grown around the globe to generally meet requirements whatever the approach to manufacturing.

There is not any “special sauce” here. All fit-for-purpose does is allow you to ask yourself: “Are the protocols i will be considering‘fit/appropriate’ that is implementing my situation, and if not, which protocols are more ‘fit/appropriate’ based on the products I am making, the target consumer and marketplace in which the products are to be sold?”“Fit-for-purpose is a powerful concept that can be used for simplifying regulatory framework development, implementation and compliance”

A non-cannabis/hemp example of fit-for-purpose could be a scenario where a banana producer wants to implement a data management system into their cultivation practices to better track production and yields. There are many data management systems this banana producer could implement. They could implement a data management system like that of big pharma with multiple levels of redundancy and access control related to property that is intellectual other delicate information. They are able to additionally implement a data management system employed for monitoring warehouse stock; it cannot precisely capture every thing they require however it is a lot better than absolutely nothing. Neither instance is actually “fit/appropriate” towards the banana producer’s requirements. They want something in between, something which permits them to trace the sort of items they create and also the information they wish to see in a real way that is right for them. This idea is at the core of the concept that is fit-for-purpose

Applying Fit-for-Purpose

So how do we apply fit-for-purpose to the cannabis/hemp market? Fit-for-purpose decreases the discussion right down to two concerns: just what items are you about to make and exactly how do those items affect your company methods, whether that be cultivation, processing, compliance or manufacturing. The point being the products you plan to produce determine the regulations you need to follow and the standards you need to implement.

Growers can use it to guide cultivation, harvesting, handling and storage practices. Processors and product manufacturers can use it to guide their production, handling, packing and practices that are holding. Lawmakers may use it to steer the growth, enforcement and implementation of commonsense regulations. This is the simplicity and beauty of fit-for-purpose, it may be put on any situation and pertaining to any kind of product.

Growers may use fit-for-purpose to steer many areas of their procedure

Let us glance at some practical examples of fit-for-purpose for cultivators and processors. Cultivators have actually three primary aspects of focus, growing, storage and harvesting, whereas processors and product manufacturers have it a little more complicated.

Cultivation of a Cannabis Plant

Growing

Requirements for growing a* that is( plant, including those who could be classified as “hemp”, ought to be dictated by the merchandise using the strictest quality and security requirements. Including, growing for smokable fruiting tops (i.e. the plants) might need cultivation that is different than other products. You may not want to apply the same pesticides or growth additives to a* that is( plant grown for smokable fruiting tops while you would to a cannabis plant grown for seed and dietary fiber.

Harvesting

The next point is that is important and handling requirements should be agricultural, period. Except for those products intended to be vaporized or combusted and then inhaled. After our past instance, smokable fruiting tops might need different harvesting practices than many other items, particularly if you are attempting to take care of the visual quality of the items. You’ll select a harvesting that is different to collect these fruiting tops than you would if primarily harvesting the seed and fiber and thinking of the leftover biomass as secondary.

Storage

When considering the products and their storage, you need to consider each quality that is one’s security requirements. One item might have a temperature specification, whereas another may have a humidity specification. You need to make sure that you store each product according to their quality that is individual and requirements. Then think about the services and products using the greatest risks of diversion and possibly if you want to implement any protocols that are extra. Continuing our example – smokable fruiting tops, whether classifiable as “hemp” or not, pose a higher risk of theft than seeds or fiber and may require security that is additional with respect to the authority having jurisdiction.

Processing and Manufacturing Operations

When applying fit-for-purpose to processing and production operations, first you need to select the items you intend to make and specify the use that is intended each product. This allows you to identify the safety and quality demands and also the prospect of diversion for every single good. Which often lets you specify your manufacturing, processing and protocols that are handling each product related to their quality and safety requirements. Then those specific products with higher risks of diversion requiring extra protocols to be put into place depending on local regulations and/or risk that is internal, should be thought about as well as your methods modified, as necessary.

Commonsense Laws

Image if laws regulating a* that is( plant, its parts, products and associated processes were based on the intended use rather than a set of attributes that vary from jurisdiction to jurisdiction. It is complicated enough for regulators to think about a* that is( plant or cannabis item without the need to bother about if that cannabis plant or cannabis item could be categorized as “marijuana” or “hemp.” Fit-for-purpose eliminates this problem and simplifies the debate.

Using A approach that is fit-for-purpose the need to think about the molecular constituents and focuses the conversation on the intended use rather than one or two specific molecules – in this case, d9-THC, the boogie-man cannabinoid. Considering the intended use promotes consumer and health that is environmental security by permitting operators and regulators to spotlight what exactly is primary – quality and security as opposed to whether something is “marijuana” or “hemp.”

This concept is really what drives the impact that is real of. A path is created by it ahead to a single plant solution. We now have where we’re now – with “marijuana” and “hemp” – and where you want to get to – cannabis. It’s all one plant with lots of applications you can use to produce various products that are commercial. Fit-for-purpose helps bridge the gap between where we are now and where we want to get to and allows us to start thinking about “marijuana” and “hemp” in the manner that is same the meant use.

Fit-for-purpose is a strong concept you can use for simplifying regulatory framework development, execution and conformity. Regulations imposed on a* that is( plant, its parts and products should be appropriate to their intended use, i.e. “fit-for-purpose.” This approach challenges the confines of the current draconian bifurcation of the* that is( plant while working inside this system to push the boundaries. It generates a path ahead to a single plant solution and begs the relevant concern: may be the globe prepared with this novel concept?

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