Navigating Compliance: program of Fit-For-Purpose

just what is “fit-for-purpose?” Fit-for-purpose is a recognised 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 services and products no matter what the variety of cannabis plant. The fit-for-purpose concept is something that may be put on any situation in the cannabis/hemp market. Simply take as an example, sustainability: a example that is practical be to design cultivation standards that are “fit-for-purpose” to the climatic region in which the plants are grown – allowing any type of cannabis plant grown anywhere in the world to meet specifications regardless of the method of production.

There is no “special sauce” here. All fit-for-purpose does is get you to ask yourself: “Are the protocols I am considering‘fit/appropriate’ that is implementing my situation, and when maybe not, which protocols are far more ‘fit/appropriate’ in line with the services and products i will be making, the mark customer and market where the items are become offered?”“Fit-for-purpose is a robust concept which you can use for simplifying regulatory framework development, implementation and compliance”

A non-cannabis/hemp exemplory instance of fit-for-purpose could possibly be a scenario where a banana producer really wants to implement a data management system in their cultivation techniques to raised track manufacturing and yields. There are numerous information administration systems this banana producer could implement. They are able to implement a data management system that way of big pharma with numerous degrees of redundancy and access control regarding property that is intellectual other sensitive data. They could also implement a data management system used for tracking warehouse inventory; it cannot exactly capture everything they need but it is better than nothing. Neither example is really “fit/appropriate” to the banana producer’s needs. They need something in between, something that allows them to track the type of products they produce and the data they want to see in a real way that is correct for them. This concept reaches the core of this concept that is fit-for-purpose

Applying Fit-for-Purpose

So how do we apply fit-for-purpose to the cannabis/hemp marketplace? Fit-for-purpose reduces the conversation down to two questions: What products are you planning to make and how do those products affect your business practices, whether that be cultivation, processing, compliance or manufacturing. The purpose being these products you intend to create determine the laws you will need to follow while the requirements you’ll want to implement.

Growers may use it to steer cultivation, harvesting, handling and storage space techniques. Processors and item manufacturers may use it to steer their manufacturing, managing, packing and practices that are holding. Lawmakers can use it to guide the development, enforcement and implementation of commonsense laws. This is actually the simplicity and beauty of fit-for-purpose, it can be applied to any situation and related to any type of product.

Growers can use fit-for-purpose to guide most aspects of their operation

Let us look at some practical examples of fit-for-purpose for cultivators and processors. Cultivators have three main areas of focus, growing, storage and harvesting, whereas processors and item manufacturers own it a tad bit more complicated.

Cultivation of a Cannabis Plant

Growing

Requirements for growing a* that is( plant, including those that can be classified as “hemp”, should be dictated by the product with the strictest quality and safety specifications. For example, growing for smokable fruiting tops (i.e. the flowers) may require cultivation that is different than many other services and products. You might not desire to use equivalent pesticides or development ingredients to a* that is( plant grown for smokable fruiting tops as you would to a cannabis plant grown for seed and fiber.

Harvesting

The next point is that is important and control requirements must be agricultural, duration. With the exception of those services and products designed to be vaporized or combusted and then inhaled. Following our previous example, smokable fruiting tops may require different harvesting techniques than other products, especially if you are trying to maintain the aesthetic quality of these goods. You may choose a harvesting that is different to get these fruiting tops than you’d if mainly harvesting the seed and dietary fiber and thinking about the leftover biomass as secondary.

Storage

When taking into consideration the services and products and their storage space, you will need to give consideration to each quality that is one’s safety specifications. One product might have a temperature specification, whereas another could have a humidity specification. You’ll want to make certain you shop each item in accordance with their quality that is individual and specifications. Then consider the products with the highest risks of diversion and potentially if you need to implement any protocols that are extra. Continuing our example – smokable fruiting tops, whether classifiable as “hemp” or otherwise not, pose an increased threat of theft than seeds or dietary fiber and could need security that is additional depending on the authority having jurisdiction.

Processing and Manufacturing Operations

When applying fit-for-purpose to processing and manufacturing operations, first you must choose the products you want to make and specify the use that is intended each item. This permits you to definitely determine the safety and quality requirements and the potential for diversion for each good. Which in turn allows you to specify your manufacturing, processing and protocols that are handling each item regarding their quality and security needs. Then those particular services and products with greater dangers of diversion needing additional protocols become put in destination based on neighborhood laws and/or risk that is internal, should be considered and your practices modified, as necessary.

Commonsense Regulations

Image if regulations governing a* that is( plant, its components, services and products and associated procedures had been centered on the intended usage in the place of a collection of characteristics that differ from jurisdiction to jurisdiction. It really is complicated sufficient for regulators to give some thought to a* that is( plant or cannabis product without having to worry about if that cannabis plant or cannabis product can be classified as “marijuana” or “hemp.” Fit-for-purpose removes this complication and simplifies the debate.

Using A approach that is fit-for-purpose the requirement to take into account the molecular constituents and concentrates the discussion in the intended usage in the place of 1 or 2 specific particles – in this instance, d9-THC, the boogie-man cannabinoid. Thinking about the meant use encourages customer and health that is environmental safety by allowing operators and regulators to focus on what is most important – quality and safety instead of whether something is “marijuana” or “hemp.”

This idea is what drives the impact that is real of. A path is created by it forward to a one plant solution. We have where we are now – with “marijuana” and “hemp” – and where we want to get to – cannabis. It is all one plant with many different applications that can be used to create different products that are commercial. Fit-for-purpose helps bridge the space between where we have been now and where we should arrive at and we can begin thinking about “marijuana” and “hemp” within the manner that is same the intended use.

Fit-for-purpose is a powerful concept that can be used for simplifying regulatory framework development, implementation and compliance. Regulations imposed on a* that is( plant, its components and services and products must be appropriate to their meant use, in other words. “fit-for-purpose.” This process challenges the confines of this present draconian bifurcation of the* that is( plant while working within this system to push the boundaries. It creates a path forward to a one plant solution and begs the relevant concern: could be the globe prepared with this novel concept?

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