Cannabis Seed to Sale Software – the caveats and CRF Part 11 clashes
Cannabis Seed to sale software and other computer software in general, can be a blessing to some, and a curse to others. Either way, the usefulness of paperless technology cannot be stated enough, especially in a Pharma 4.0 era. Many industries have experienced the “paper-fatigue” that arises from the requirement to generate piles and piles of documentation, and paperless systems can provide a much needed panacea for all this dead wood.
This issue is no different in the cannabis industry – the only difference is that businesses are now deciding to “design for the future” and take advantage of common pharmaceutical solutions such as green house or building management software, enterprise resource planning, laboratory software and electronic quality management systems (e.g. MS SharePoint and other on screen quality systems).
At first glance, seed to sale software also looks like it could alleviate the data recording process, however, buyers beware! There are a few critical things you need to consider prior to committing to purchasing seed to sale software (not to mention, even begin to apply it in a highly regulated medicinal cannabis facility).
1. Regulatory Requirements
Looking at the baseline regulatory requirements in Australia, for example, there is no requirement to use a seed to sale software package. The ODC does expect, however, for all licence holders to keep records of all the activity relating to the source, supply, storage and destruction of medicinal cannabis.
Straight off the ODC website, that type of data you need to keep a track of will include:
- Number of plants cultivated
- Wet and dry weight of crops produced (total)
- Wet and dry weight of crops produced (components)
- End of year stock levels of crops produced (wet and dry weight)
- Transactions of cannabis along the supply chain (e.g. to customers, third party manufacturers or storage, testing laboratories, waste disposal, etc.)
- Forecast production for the next calendar year
- Forecast end of year stock for the next calendar year
Reviewing these requirements brings up two main points for consideration:
- How do you accurately track your inventory from its initial arrival onto site, all the way to its departure offsite?
- What is the best method to facilitate this?
Your solution might actually be not to use seed to sale software, however your choice will depend on several variables, e.g.:
- How many plants are you planning on cultivating? (i.e. how big is your facility?)
- How many strains are you planning on cultivating?
- How many growing regimens will be implemented?
- What types of products are generated? (e.g. whole flower, resin, oil, etc.)
- How many different products are generated? (e.g. just whole flower vs flower, oil, capsules, etc.)
In addition to this, and arguably, one of the most crucial variables to consider: what level of Good Manufacturing Practice (GMP) does your site require?
2. GAP vs GMP
While cultivation activities are governed mainly by Good Agricultural Practice (GAP), if you’re cultivating AND manufacturing, you cross the line from Good Agricultural Practices into Good Manufacturing Practices.
GMP brings with it, not only the additional requirement for a TGA manufacturing licence, but also for all software (including any seed to sale software) used in the facility to be Annex 11 compliant (most industry professionals will probably refer to it as 21 CFR Part 11 Compliant).
But what does this mean? Essentially, if any kind of seed to sale software is going to be used in a GMP manufacturing environment, it will require validation activities to be carried out to prove that it will perform as described and can fulfil your critical business requirements prior to its use.
This is in line with modern pharmaceutical manufacturing process controls, which involves performing a documented risk assessment to evaluate desired product characteristics (i.e. your critical quality attributes) and designing parameters into your process in order to achieve it.
3. The Bare Minimum
Regardless of whether or not you wish to utilise seed to sale software, to address the “regulatory critical quality attributes” in Section 1, you would need to be able to do the following as a minimum:
- Track the ID and movement of each seed throughout your facility
- Track the ID and movement of each clone generated from a mother plant or tissue culture throughout the facility
- Keep records of all active plants throughout the facility
- Keep records of harvested plant material (wet and dry)
- Keep a record plant mortality (strike rates) for those plants that fail to germinate
- Keep a record of the quantities and movement of cannabis waste is produced and destroyed on and off site
- Keep a record of how much cannabis product (including cultivated material for further processing) is produced and supplied and to whom.
- Summarise and report the quantities of medicinal cannabis sourced, supplied, stored and destroyed, to the TGA on a quarterly basis.
As you can imagine, the issue is even more complicated when you bring in the manufacturing side!
4. Lost in Translation
The confusion over the seed to sale software compliance requirements for medicinal cannabis has arisen mainly due to two reasons:
- More advanced recreational markets overseas, and
- Differing country regulatory requirements.
These variables seem to have generated some seed to sale software that, while efficient, is unvalidated or unable to be validated by the client; CRF Part 11 compliance was not a prerequisite in the initial seed to sale software design and its purpose was to function more as a business inventory as opposed to a compliant aide for regulatory checks and balances. This means that the seed to sale software will be unable to be used ‘out of the box’ in an Australian GMP environment.
Another important thing to bear in mind, is even if the intention of your business is to solely cultivate and export, you must also assess the regulatory requirements of your target foreign markets. Countries, such as Germany, may expect cultivation activities to be performed in GMP conditions. In this case, if planning on implementing cannabis seed to sale software, it would definitely have to be CRF Part 11 compliant.
To help our clients pick the best solution, we have done a review of the currently available seed to sale software on the market. As we suspected, more than a few do not comply (see bottom row of the picture below).
5. So, What Now?
If you have already purchased a seed to sale software and are unsure as to whether or not it meets the Australian Regulatory requirements, we have prepared a couple of useful links:
- First, a white paper that covers computer system validation
- Secondly, a free Part 11 Supplier Assessment Checklist so you can verify if the seed to sale software is suitable for your requirements.
If you already know that your seed to sale software is not compliant and are eager to perform some corrective or mediating actions, a few options are available to you:
- Perform a risk assessment of the planned activities in your facility, this will help to identify your critical process parameters.
- Use the free tools (the white paper and part 11 checklist) to perform a gap analysis of the seed to sale software. Once you have identified the weaknesses, you can design in some manual steps to help you ensure that data integrity is maintained. (e.g. print outs, witnesses and countersignatures.)
- Get in touch! We are more than happy to help with any queries, Part 11 compliance audits, regulatory problems, or remediation activities.
If you are a cannabis seed to sale software supplier and believe that your product will fully meet international GMPs and Part 11 compliance, please get in touch and we will gladly include it on our register and present it as an option for our clients to review.
If you liked this article, these other blogs may also interest you:
The Price of Cannabis
Dessicant Dehumidification in Greenhouses
5 Top Cannabis Cultivation Facility Design Tips
The Indoor vs Outdoor Debate
What to look for in a GMP cannabis consultant