Considerations for successive harvests
Happy New Year! Hopefully the holiday season has treated you all well and the newly arrived seed catalogs are littered with sticky notes marking important pages.
Last year, I was asked numerous times how best to handle successive harvesting of the same raw material in terms of documentation and lot number creation. Many producers grow and/or wildcraft herbs for their own products and the typical process involves selecting and harvesting the desired part of the plant, be it blossoms, leaves, seeds, or roots as they become prime for harvesting. This often occurs over days or weeks, so how does one create a ‘batch’ or lot from these successive harvests?
The GMP (Good Manufacturing Practices) for Dietary Supplements (21 CFR 111) specifies control of components used in the manufacturing of dietary supplements by requiring unique identification numbers for each unique lot of components. Defining what constitutes a batch comprised of successive harvests is more nuanced than merely purchasing a pound of the same product from a wholesaler. As with any section of the GMP, there’s not one and only one way to meet this requirement. Below are some items to consider as you define your unique lots for successive harvests.
Raw Material Specification - A raw material specification indicates the form and acceptable conditions required for every component used to make a dietary supplement. Beginning with the requirements you’ve defined, you can backtrack into a definition for what constitutes a unique batch of harvested materials. What form of raw material do you need to make your final product? It may vary depending on its intended use and you may use some in fresh form, some in dried whole leaf, or some in dried powder.
What makes it unique? A ‘unique’ batch implies some type of uniformity of the product. The most unique batch harvested is all desired product collected at the same time from the same location. But in successive harvesting, that amount may be too small to make a usable batch further down in production. Likewise, collecting that same product over a month and calling it a unique batch may represent highly variable environmental conditions. Additionally, per the regulation, a batch of components must be ‘accepted' before use and collecting over too long of a timeframe would prevent you from using that batch before it was completely collected. How you define your harvested batch should be carefully considered so that it mimics your current processing and that it meets the requirements.
Once you’ve defined your unique batch, ensure that you generate a record of every harvest activity to record date, location, and other conditions that may affect the quality of the product. Harvesting records are excellent historical snapshots of the product you collected. And finally, all of these activities should be well documented in an approved SOP (standard operating procedure) that explains the steps you take to harvest and create a unique batch of components used in your final products. Harvesting Forms are available under the GACP tab. A new harvesting form for successive harvests will be available next week.
Growing and harvesting your own botanical ingredients is possibly the most important step in ensuring the quality of your products and also the most rewarding. With adulteration and contamination of herbal components on the rise within the supply chain, remove this risk by growing your own!
It’s a great time to get your documentation in place now before spring planting and to tighten up your formulations. Feel free to contact me or Elizabeth with any questions.
~ Anne