GACP Assessment

Description

Orion GMP Solutions has identified over $30,000,000 in product failure attributed to preventable causes. In many cases, the root causes of failure would have been prevented with adequate planning in the design qualification phase. Nonetheless, all manufacturers can benefit by understanding where their organization stands on meeting international GACP and GMP guidelines for cannabis.

This guided GACP audit is the fastest way to assess your cannabis cultivation’s operational readiness to access international markets, as well as meeting national GMP requirements that are common to the FDA, EMA, and TGA. Hiring a firm to audit your organization takes weeks to schedule and costs thousands of dollars. Most often, our first observation in an organization is that it needs to hire more personnel to become GMP compliant! You don’t need us to come on site to determine that when you know your organization better than anyone else.

Save yourself the time and get the answers today – sign up and take the Orion GMP Solutions guided GACP assessment and get the answers to start distributing cannabis into the EU!

What is the GACP Assessment?

The GACP Assessment is the industry’s first risk management based remote audit that integrates World Health Organization, FDA Botanical Drug Development Guidelines, EU GACP and GMP guidelines, and ASTM standards. Collectively, these guidelines ask the most important questions to verify GACP compliance prior to an EU GMP Qualified Person to audit your operations.

Our reporting system allows you to download a PDF printout that details your self-assessment of compliance. For many organizations, it is more than sufficient to get started on a GACP implementation, and direct your quality assurance and quality control staff to execute the work.

Why do I want the consultant responses to the GACP Assessment?

While it’s useful to realize where you can improve your systems, our consultants can provide you the quick answers to what you need and the best solution to the problem. The vast majority of cannabis businesses are in their first 5 years of operations. From our experience, no company is “GMP compliant” on day 1. It takes time to understand the highly customized environment that was built to produce cannabis substance and cannabis products, and it requires custom answers to make it GMP compliant. This is the fastest way to get answers and be connected with the right solutions the first time.

Why is the GACP Assessment priced like it is?

The GACP Assessment is priced at $600 to include customized responses. We have automated our remote auditing process in order to accommodate a number of cannabis businesses in various stages. Having performed on-site audits and consulting across Canada, the United States, South America, and

the EU, we have found that many non-conformances could have been resolved remotely. The cost to industry for these types of expenses is unnecessary when we have successfully solved these problems by online tools and our Project Management Office.

Are there any discounts?

Orion GMP Solutions is a veteran owned small business and recognizes the challenges of starting and operating a profitable business. 10% discounts are extended to women, veteran, scientist, and minority owned businesses.Organizations that are members of ASTM D37 Cannabis Standards Committee receive a 10% discount.

What happens after I’ve completed the GACP Assessment?

After you and your staff have completed the GACP Assessment, our consultants will verify your results and that all answers are complete. Each of the answers will be evaluated for “criticality,” and then ranked according the risk it presents your organization for compliance. The consultant will then provide responses with the appropriate corrective actions your organization must complete to become GACP compliant.

What happens after I’ve received the completed report?

In many cases, there are fundamental activities an organization must go through to demonstrate their GACP compliance. For example, bulk packaging of cannabis substance is a critical process that requires a calibrated weighing device. Why is this important? Because the fill weight of the container is directly related to the amount of active substance and the value of the container, not to mention, all of these numbers must ultimately be reported to the United Nations!

This could be a simple case of providing guidance, or an SOP, on how to calibrate you balances, or manage the calibration of all your measuring devices. When we dive into the consulting process we often see non-conformances where activities like process mapping are required across the entire operation, that then lead to more accurate batch records that demonstrate the process is under control. The point is, our consulting process solves specific problems, but gives your team the tools it needs to integrate into the long-term operations of the company.

Where do we go after the GACP Assessment is complete?

If your company finds value in the customized responses, we can carry on the consulting relationship on a time and materials basis to the extent that your project requires. Often times, it’s a matter of us helping you get in contact with the right companies and vendors of services that can immediately and better solve your problems than we can. Either way, we make sure you get the right answers from the qualified experts.

The GxP advantage:

What is the GxP advantage?

GxP encompasses many aspects of quality control for your business that were initially validated for food and pharmaceutical safety. These proven philosophies with proper implementation are a boon to the cannabis world as we move towards standardizing and producing the highest quality products. Adoption of GxP standards provides the advantage of knowing your product will be widely accepted while promoting early entry into domestic and international markets as they open. . Considering the speed at which cannabis laws are being reformed worldwide, adoption of GxP standards now will return its investment many times over with each legislative victory