THC Cannabis
Every state that has legalized THC cannabis has their own unique requirements and challenges that can quickly become overwhelming to keep track of. That’s where Allay comes in. We take care of the nitty gritty compliance work so that our clients can focus on running their business. Whether you need specific state regulations, or want to go above and beyond preparing yourself for future federal legalization we can help.
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
cGMP stands for Current Good Manufacturing Practices and is promulgated by the FDA. cGMP regulations require a quality and safety approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups, and errors. It is designed to reduce the risks involved in all steps of the manufacturing process.
Allay Consulting are cGMP/ FDA experts and can help your company evaluate the workplace, put together all of the required documentation, SOP’s, ensure quality assurance, and training required to receive the certification from an accredited certifying body. The best way to understand where your business stands with compliance is to schedule a full cGMP gap analysis with an Allay Consultant.
GACP Certification Assistance
A popular certification for cultivators is the Good Agricultural and Collection Practices (known as GACP or GAP). This highly sought after certification is the equivalent of cGMP certification but specific to cultivations. The GACP is a robust audit process that demonstrates cultivators are growing their plants safely, growing with quality and with consistent best practices. Agricultural practices help ensure the wellbeing of their consumers, workers, and to protect the environment in which they’re working.
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.
ISO 9001 Certification Assistance
ISO 9001 is a quality management compliance certification that is geared toward a variety of plant-based medicine companies. This certification helps ensure companies implement a quality management system (QMS) to ensure customer satisfaction and continual improvement. Allay Consultants can assist with implementing the ISO standard through documentation, trainings, and including quality management in the culture of the company.
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 the following compliance standards:
- cGMP
- GACP
- OSHA
- ISO
- Organic
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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