Kratom

The American Kratom Association (AKA) created a kratom specific GMP program to help ensure consumers have access to safe products. Under their GMP Standards Program, kratom companies undergo a GMP audit from a third-party company. The independent third-party auditors are vetted and approved by AKA, including Allay Consulting. After passing the GMP audit, the kratom company is placed on AKA’s website as a trusted vendor. To ensure ongoing compliance, each kratom company must complete and pass an annual third-party re-certification audit.

If you’re seeking a new GMP audit or a re-certification GMP audit with the AKA, feel free to reach out!

How we help

OSHA Compliance

OSHA has jurisdiction among all cannabis companies in the US. OSHA exists to ensure safe and healthful working conditions for working people. The safety of your employees is important and Allay Consulting can assist you with workplace evaluation, required documentation, SOP’s, and employee training to ensure your workplace is OSHA compliant. OSHA will likely visit your company’s facility sometime in the near future, don’t risk unknowingly having an unsafe work environment and getting fined by not being compliant.

FDA Compliance

Product safety standards cover everything from employee hygiene, food handling, safe sourcing of ingredients, traceability, to temperature control requirements, etc. While some states and counties have scheduled local health department inspections, others are still working towards developing their requirements. Upgrading to compliant product safety standards now can reduce the risk of outbreaks, hefty fines, closures, or even loss of license.

Allay can assist with CFR 117(food/food ingredients), 111 (dietary supplements) & 211 (pharmaceutical) regulations. The easiest way to become FDA compliant is through cGMP certification.

CGMP Certification Assistance

If you’re seeking a new GMP audit or a re-certification GMP audit with the AKA, Allay can support your company via these steps:

  1. Schedule a meeting with Allay Consulting. Our consultants will discuss the audit process, pricing, and scheduling the audit.
  2. When the audit date arrives, Allay consultants will review the physical facility, take a deep dive into the GMP and Quality Management System documentation, and review any non-conforming items identified. (If any non-conforming items were identified, a deadline to correct these non-conforming will be scheduled.)
  3. Receive corrected non-conforming items as confirmation of the improvement. AKA states companies have up to three audits to “pass” their approval process.
  4. Allay Consulting will provide a report to AKA with final audit results.

SOP Development

An SOP, is a set of step-by-step instructions to help workers carry out routine operations. With our unique approach, Allay can help your business build SOPs to achieve efficiency and performance, while reducing miscommunication and failure to comply with industry regulations.

State Regulations

Every state has different and unique regulations and rules that companies have to follow in order to stay compliant and operational. Unfortunately, these regulations are constantly evolving as the hemp and THC cannabis industry matures. Everything from SOPs, to inventory management, to floorplan requirements, to product management, and security can all differ from state to state.

The good news is that Allay Consulting can help your company stay compliant no matter if you are in one state, or a multi-state operator (MSO).

Gap Analysis (Mock Audits)

Thinking about buying a cannabis company or investing in one but don’t know enough about compliance to know if it’s a great idea? Already have the facility that needs a regulatory review? Allay Consulting frequently conducts facility audits to ensure state specific compliance, cGMP, GACP, OSHA, ISO, and organic compliance. This is typically the first step when seeking to achieve various certifications. Start with a gap analysis to understand your company’s compliance pitfalls. Allay provides a detailed roadmap of each step your business must take before becoming compliant.

We can perform GAP analysis for Kratom the following compliance standards:

  • cGMP
  • OSHA

Floor Plan Review

The Floor Plan Review is a form of gap analysis that typically takes place before a facility is operational, and it is best practice to ensure they are built with applicable regulations and standards in mind. Making sure a company has good production flow, compliant surfaces, equipment, drainage, and ventilation are all things being considered during a plan review. This is an area where Allay saves our clients a lot of money by preventing costly facility updates down the line.

Label Review

When a consumer sees your product on the shelf, labeling is one of the first things that jumps out at them. Unfortunately, designing the correct labels for products can be difficult when so much of it is mandated by regulatory standards. Avoiding false statements and broad health claims can be difficult to try to navigate through as an emerging business.

At Allay, we ensure that your labeling is compliant in order to help keep customers safe, keep your products on the shelf, and protect your company from fines and recalls.

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