October 1, 2020
The interest in developing consumer products or therapies derived from Cannabis or CBD is continuously growing. As these new products come to market, there is increasing need to comply with established rules and regulations for medicinal products. Additionally, the FDA has concerns that these new products might not be in line with the Federal Food, Drug and Cosmetic Act (FD&C Act) and could potentially be harmful without proper quality and validation procedures.
Traditionally, supplement business is handled by an arrangement of contracts to maintain a low-cost supply chain, particularly the quality control laboratories, due to the high cost of analytical equipment and trained personnel. So how can you ensure cost-effective product development and accelerate time to market, all while regulations are being met? Having the right partners for regulated cannabis testing is a step in the right direction. Which leads to the next question, how do you select the perfect partner? Here are our top tips to help you identify your perfect partner for regulated cannabis testing.
Firstly, you need to know the requirements for a laboratory. FDA Good Manufacturing Practices, or GMPs, 21 CFR Part 211 can help you answer the questions below to determine the requirements for laboratory operations.
Whether you are brand new to the market or an existing business in hemp production, you need to know that your laboratory partner is in compliance with this regulation.
First generate a check sheet or form that can be updated in your company Suppliers Qualification Standard Operating Procedure (SQSOP) to compile lessons learned, then request and document the following:
You should ultimately seek to identify a laboratory partner that is compliant, reliable, and responsive to your company’s needs.
A risk assessment procedure is highly recommended in your company quality management system, or QMS, to document all assumptions and laboratory selection rational. Always maintain your QMS, to ensure it is up-to-date against regulations. Plan, verify, and review your processes, systems, and laboratory selection at least every two years. Keep in mind that a good reproducible process maintains a lower production cost and eliminates unnecessary investigations costs and product rejections. Quality results from your laboratory selection will validate your process thus your product quality, which will impact earning client product acceptance.
Lastly, let us review the minimum readiness you must demonstrate. (For more details, please visit FDA.gov.)
Once you have completed all the above, follow your company Suppliers Qualification Standard Operating Procedure. The supplier qualification SOP allows your company to have and maintain a list of approved suppliers that comply with required standards. This is critical, since any raw material can impact your final product quality.
And what about regulations for regions outside of the US, such as the EU? They have their own specifications and requirements, depending on the region. On top of (or despite) all the efforts to have common EU regulations, there are still many differences in these between individual EU countries.
If you need help establishing a QMS, creating SOPs, or selecting a laboratory testing partner for your cannabis products, the experts at ProPharma Group can help. Our global team has the experience and expertise to help you achieve cost-effective and speedy development, while ensuring compliance with regulatory expectations.
TAGS: Life Science Consulting
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