If you are manufacturing medical marijuana / medicinal cannabis products then you will likely be supplying them to Authorised Prescribers, pharmacies or other approved third-party outlets either in Australia or overseas.
The process of storing, supplying or exporting medicinal products (but not supplying products to the public) is called the wholesale distribution of medicinal products. This process is also regulated due to its potential impact on product quality. Regulation of the wholesaling of medicines is done at the state level as well as under the Australian Code of Good Wholesaling Practice of Medicines.
You can imagine the potential risk to your medicinal product if it is stored next to corrosive cleaning products in a warehouse, or left in a hot truck for hours or days. There’s also the risk of theft or tampering if someone sees your clearly labelled medical marijuana / medicinal cannabis product on the back of a truck, on its way to your customers.
If you hold a TGA Licence to Manufacture (GMP), this covers every step up to and including the supply of the medicine to the point of release for supply. This includes warehousing and distribution. The TGA will expect you to follow Good Wholesaling Practice (GWP).
This includes controlling the following aspects:
- Buildings & grounds
- Control over stock handling and stock control, including:
- Inwards goods
- Damaged goods
- Returned goods from customers
- Returned goods – e.g. from a product recall
- Transport activities – e.g. temperature control
- Customer complaints
Let’s look at a couple of these aspects in more detail:
Buildings and Grounds – Warehousing
The design of your warehouse can have a big impact on the efficiency of your product dispatch processes. A good design can minimize the time spent locating product in the warehouse, packaging it and shipping it. This translates to lower labour costs for you and less potential for product loss or damage.
You need to consider future growth and how to minimize the size of your warehouse (and the associated costs) by using an efficient design. Just to illustrate how important this is, a major pharmaceutical manufacturer in Australia ‘lost’ $1 million worth of product in their warehouse and it wasn’t located until after the product’s expiration date. Ouch!
You need to consider the following when planning/selecting your warehouse:
- Temperature and humidity control – you need to know how to store your product(s) to ensure they maintain their quality until the expiry date
- Cleanliness – you must have processes in place to ensure the warehouse remains clean and tidy. Auditors will be looking for things like pest control and documented cleaning processes.
- Storage solutions – you may need to cater for different products that are used at different rates. You don’t want your warehouse staff having to pull out stock that is used infrequently, just to access the more popular products.
- Separate storage areas – if an auditor walks into your warehouse and sees non-medicinal products (e.g. cleaning supplies) stored next to your medicines they won’t be happy. You need to have separate areas for the storage of your medicinal products and other goods.
- Storing materials at from different stages of your product’s lifecycle – raw materials, final products and returned products must all be considered in the design of your warehouse.
Secure Storage Areas
The Australian Office of Drug Control requires that you have a secure storage area if you have a licence to produce medicinal cannabis / medical marijuana. There may be a similar requirement if you hold a state-based poisons licence.
A vault is a walk-in safe where you keep reference samples, as well as stability testing samples and if needed: rejected or returned samples – including those associated with a product recall. Depending on your situation, you may not need a bank-like vault, but it will need to comply with a classification VII strongroom as per AS/NZS 3809:1998 Safes and strongrooms.
Using a software system to manage inventory is essential. The Australian Office of Drug Control expects all licence holders to keep records of all the activity relating to the source, supply, storage and destruction of medicinal cannabis therefore you must to be able to account for everything you’ve produced (and who you shipped it to), including product that went to waste.
Note that if you are manufacturing product (and thus have a TGA licence to do so) all software must be compliant with the 21 CFR Part 11 / Annex 11 regulations (this also applies to your Seed to Sale software). In addition, with an inventory management system in place it will be much easier to prepare the quarterly reports required by the TGA on the quantities of medicinal cannabis sourced, supplied, stored and destroyed.
Shipping your product to your customers is another important part of the supply chain. Good Wholesaling Practice requires that you ensure that your products are transported under the labelled storage conditions. You must have data that shows you have validated your product’s transportation to your customers. This data must prove that the product was maintained at the correct temperature, humidity etc., to ensure its quality has been maintained at the point of supply to the final consumer.
Part of that validation process is a risk assessment: what are the things that might go wrong and impact the quality of your product? This could include things like transport delays, failure of monitoring devices, contamination from other products or extreme weather events.
Based on the risk assessment you will then gather data from the transportation of your product to prove that the risks are managed. This means that you can’t ship product with just any old courier. You must have contracts with logistics companies that define their responsibilities in terms of ensuring the correct product transport and storage conditions. The ODC or GMP inspectors may also ask to see these contracts.
If you have any questions on Good Warehousing Practices, feel free to get in touch here.
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