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.
Requirements for Laboratory Operations
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.
- What are the requirements for written procedure?
- What are the requirements for the laboratory facilities that you use?
- What are the requirements for laboratory control process?
- What requirements apply to laboratory methods for testing and examination?
- What records must you make and keep?
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.
Got it, but What I Should be Looking for From my Future Laboratory Partner?
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:
- Conduct a qualification audit of the laboratory.
- Request specific certification, registration, license, or accreditation.
- Consider the laboratory’s specialty area of expertise.
- Look for a local cannabis laboratory to reduce sampling travel time.
- Request a list of qualified equipment.
- Request Method Validations reports for each test you are going to need.
- Verify traceability of testing standards.
- Evaluate the experience and education of the laboratory personnel.
- Request prior audit experiences.
- Consider laboratory response time commitment.
- Evaluate the laboratory’s financial and business stability.
You should ultimately seek to identify a laboratory partner that is compliant, reliable, and responsive to your company’s needs.
How Should my Company Document and Maintain the Laboratory Selection?
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.
How Should I Prepare for Laboratory Partner Selection?
Lastly, let us review the minimum readiness you must demonstrate. (For more details, please visit FDA.gov.)
- Registration is required by states or countries to allow companies to do business in the specific region.
- Manufacturing Site Address/Location
- Product Filing or equivalent
- Label claims should be aligned to country or state regulation, followed by Agency requirements (i.e., Food and Drug Administration (FDA)).
- The final product recommendations should be supported by scientific evidence.
- Quality Management System is fully implemented.
- Establish a Supplier Qualification Standard Operating Procedure (SQSOP) to demonstrate due diligence of the company in evaluation of supplier’s compliance against regulations (i.e., starting material quality).
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.
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