If you’ve been following the industry trends, you’re aware that everything is moving in the direction of more regulations and something called GMP.
If you haven’t heard of GMP, you’re not alone. It’s not something that’s been commonly associated with cannabis or CBD, but as the industry continues to develop, more oversight is need to help keep consumers safe and make sure the products making to the shelves are of the highest quality possible.
What is GMP?
GMP (Good Manufacturing Practice) is a system designed to ensure that products such as medicines and supplements are produced with consistency and a certain level of quality. The point of GMP is minimize any errors that could possibly occur during production, after final testing of the product has already been completed.
Although GMP standards are implemented worldwide, the specific guidelines vary from country to country and are known to change frequently. GMP is overseen by regulatory agencies in the United Kingdom, United States, Canada, Israel, Europe, China, India, and many other countries.
GMP constitutes the license to operate in pharmaceutical manufacturing, and is a core condition worldwide. However, rules and interpretations differ from country to country and change frequently. Therefore, having fully trained experts at hand to help with the implementation of these rules is very important.
It can get a bit complicated keeping up with constant variations, it can hemp to consult with someone who is well versed in global GMP policies.
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All GMP guideline follows a few basic principles:
- Manufacturing facilities must maintain a clean and hygienic manufacturing area.
- Manufacturing facilities must maintain controlled environmental conditions in order to prevent cross-contamination from adulterants and allergens that may render the product unsafe for human consumption or use.
- Manufacturing processes must be clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
- Manufacturing processes must be controlled, and any changes to the process must be evaluated. Changes that affect the quality of the drug are validated as necessary.
- Instructions and procedures must be written in clear and unambiguous language using good documentation practices.
- Operators must be trained to carry out and document procedures.
- Records must be made, manually or electronically, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the food or drug was as expected. Deviations must be investigated and documented.
- Records of manufacture (including distribution) that enable the complete history of a batch to be traced must be retained in a comprehensible and accessible form.
- Any distribution of products must minimize any risk to their quality.
- A system must be in place for recalling any batch from sale or supply.
- Complaints about marketed products must be examined, the causes of quality defects must be investigated, and appropriate measures must be taken with respect to the defective products and to prevent recurrence.
It’s important to note that in some countries, the United States for example, may label a products as being “adulterated” if it was discovered to have been produced in a facility that violates GMP policies, even if said product has passed all the other specifications tests.
What is ISO certification?
ISO (International Organization for Standardization) Certification typically goes hand in hand with GMP. Summarized, it guarantees that any manufacturing process, documentation procedure, service, or management system has all the requirements needed for standardization. It’s basically another layer to ensuring ultimate quality of all products produced.
ISO certifications are a part of many industries including energy management, medical device manufacturing, and soon, the production of cannabis products. There are a couple different levels of ISO certification, but the most common one is 9001:2008.
All products appearing under the ISO 9000 category refer to quality control management. 9001 the best-known ISO standard and it helps businesses and organizations better satisfy their consumers by being more efficient.
The number 2008 refers to the version of the standard that’s being applied and when those standards were established. 2008 is when the fourth and most recent edition of ISO 9001 was launched. There is an ISO 9001:2015 that was launched in September 2015, but that only applies to certain metal industries.
Are GMP Products Better?
The easy is answer is yes but that’s not always true. Some non-GMP products can be produced under all the same restrictions but they just don’t have the official certification. They quality is good but there is just no way to verify this.
Because GMP products are certified, there’s a guarantee of safety and quality – which translates to peace of mind for your consumers. Some of the top CBD manufactures already hold Good Manufacturing Process (GMP) certification as well as Governance and Professional Practice (GPP) certification.
It’s important to stock products like this in your shop because it shows your customers your willing to go the extra step to ensure their safety and satisfaction.
The way of the future
Like it or not, more regulations are coming our way and GMP/ISO products are the way of the future. Making sure that you have GMP products in your shop will keep you ahead of the curve when, one day, GMP products are the only ones that will sell.