GMP MEDICAL MARIJUANA MANUFACTURING
11 -12 - Filling, Capping, Labelling of GMP Medical Marijuana
Filling, Capping, Labelling – the medical marijuana manufacturing / packaging process
As the last stages of the 12 stage medical marijuana manufacturing (medical cannabis) or production process, filling, capping and labelling are classic pharmaceutical processes. This means they are heavily regulated to ensure product quality and efficacy. All pharmaceutical products must meet these regulations before they can be sold and the Medical Marijuana manufacturer must ensure ongoing GMP compliance.
If you are producing a final medicinal marijuana product that will consumed by patients then you’ll need to consider the following:
The final dosage form – what the patients will use
Your final medicinal marijuana product could be in a range of forms (called the Final Dosage Form in the pharmaceutical industry). This could include:
- Liquids – Tinctures
- Soft Gel Capsules
- Hard shell capsules
- Chewable gels e.g. Gummy candy
- Inhalers and nebulizers
- Lotions or gels
- Skin patches or under the tongue lozenges
A Medical Marijuana Manufacturer often produces a range of different final dosage forms with the same active cannabis-derived ingredients. Each needs to be registered with your local authority, such as the Australian Therapeutic Goods Administration. This is an expensive, time-consuming and difficult process that requires the submission of a lot of scientific data and clinical evidence. You are, after all, selling a medicine. You must prove to the agency in which you are selling that your product is both effective in treating whatever ailment you are targeting as well as being safe for patients to consume.
Filling, Capping and Labelling Medical Marijuana
Once you’ve manufactured the medical marijuana final dosage form of your product it will usually need to be packaged somehow, ready for sale. Packaging involves the filling of the packaging with your product, closing the packaging (with a cap or other method) and then labelling the packaging.
- Packaging compatibility: You need to prove that the packaging you have selected does not chemically react with your product
- Tamper-evidence: Your packaging must comply with tamper-evidence guidelines
- Child-proof packaging: You must supply your product in packaging that is child-proof.
- Stability testing: You need to have scientific data to proves that your product is shelf-stable, for how long and under what conditions. This information is then used to determine the expiry date and storage conditions that will be printed on each batch of product.
Labelling – where things often go wrong
The printed labelling on your product packaging must comply with the appropriate country regulations, for example in Australia the TGA’s TGO 91 and TGO 92 are the two key ones. The TGA will conduct a pre-market evaluation to assess your product against those mandatory labelling and packaging requirements.
They will assess the label to check that it includes:
- the product name;
- name(s) of all active ingredients and their quantity;
- in some cases, excipient information;
- batch number;
- expiry date;
- relevant warning/advisory statements;
- storage conditions;
- directions for use;
- in most cases the indications for which the product is used; and compliance with tamper-evidence requirements
Managing changes to labels
It’s important to have robust processes in place to manage ongoing changes to your product labelling. Incorrect product labelling is the major cause of pharmaceutical product recalls. A labelling change could be anything from a change to the warning statements through to changing label suppliers (who use the wrong ink on your labels, which subsequently rub off on the patient’s hands, becoming illegible).
Validation – what you need to know
One of the requirements of being a manufacturer of pharmaceutical products is being able to prove that your processes can deliver consistent, repeatable, reliable outcomes. For example, you will need to prove that the process that creates your final dosage form can always deliver a product that contains the right amount of the right ingredients, which are evenly spread through the product. You need to prove that your packaging process will always produce a packaged product that will be protected from degradation until the expiry date.
To prove to a Regulatory Inspector that your processes are sound requires rigorous testing of your processes and the collection of lots of data about them. This process is called ‘Validation’. Validation is major activity within pharmaceutical companies. There’s usually a separate Validation Department within most large pharmaceutical companies. Smaller companies usually outsource it to specialists.
The propagation of cannabis plants is regulated by the Australian Office of Drug Control. In Australia you must hold a licence and permit from them to cultivate cannabis (they control the plant during it’s lifecycle). Once the plant has been harvested and moves into the production of the final medicinal product then the Australian Therapeutic Goods Administration (TGA) is the regulator. This part of the manufacturing process must comply with the countries current Good Manufacturing Practice (cGMP) guidelines. These rules are designed to ensure the safety and efficacy of all pharmaceutical drugs sold in Australia. The rules cover everything from facility design through production processes to the packaging, labelling, storage and transport of the final drug product.
Services PharmOut offers:
PharmOut has a wealth of experience in the pharmaceutical industry. The production and packaging of a final pharmaceutical product is one of our core areas of expertise.
We can help you with:
- Registering your product with the Australian TGA
- Understanding the regulatory requirements, including obtaining a GMP Manufacturing licence for your facility
- Designing and creating a Quality Management System for your facility
- Validating your facility, service and equipment as well as your processes
- Getting ready for a GMP Inspection and/or responding to a GMP Inspection.
- Selecting key staff
Obviously the comments above are very general in nature and illustrates the Australian requirements only and as the industry is rapidly evolving, regulations are constantly changing we caution you to get current advice. PharmOut is an international organisation and has considerable experience with most international regulatory frameworks, EU, US FDA and PIC/S.