EU GMP Validation - Ziel’s Turnkey Package to Achieve Validation for Cannabis Microbial Decontamination
Ziel works with you to complete all IQ, OQ, and PQ documentation for your Ziel RFX. EU GMP validation for cannabis has never been more streamlined.
Shorten Your Time to EU GMP Validation with Ziel
Within the same week of installing your Ziel RFX microbial decontamination solution, you’ll have completed the IQ and OQ documentation and started on the PQ documentation. You’ll have everything you need before we leave your facility.
Adding Ziel RFX to your cannabis operation means:
- Using the only decontamination tech in cannabis with an EU GMP validation-ready turnkey solution
- Skipping the back-and-forth for documentation approvals between your team and ours
- Working directly with us for customized documentation to meet your local regulatory requirements
- Leveraging Radio Frequency (RF), the decontamination solution with the highest throughput in the cannabis industry
Ziel RFX Is Already EU GMP Validated
Ziel’s RF decontamination technology was the first to earn EU GMP validation for microbial decontamination of cannabis. Regulators are familiar with the technology and recognize its value for cannabis operators and consumers.
We’ve been through the EU GMP process in multiple European countries and understand exactly what the regulators will need from you.
Radio Frequency Offers the Highest Throughput of Any Cannabis Decontamination Solution on the Market
70 KG
PER SHIFT
Ziel RFX processes up to 70kg of flower per 8-hr shift
99.9%
COMPLIANCE RATE
RF decontamination passes regulatory compliance 99.9% of the time
Pure
NON-IONIZING
RF decontamination is non-ionizing, so the integrity of your product is never compromised
Proven
GLOBAL SUCCESS
Ziel RFX is an EU GMP validated process that's easy to incorporate into any EU GMP operation
Your Fast-Track Timeline
- Days 1 - 2
Installation & IQ
Complete the Installation Qualification (IQ) documentation immediately upon arrival.
- Days 3 - 4
Operation & OQ
Operational Qualification (OQ) documents are finalized, testing all machine parameters.
- Day 5 & Beyond
PQ & Commissioning
Start Performance Qualification (PQ) during commissioning. We stay with you until submission.
Ready to Accelerate Your Validation?
Our turnkey package includes all IQ, OQ, and PQ documentation plus traceability records.
EU GMP Validation Process and Documentation FAQs
How Long Does It Take to Become EU GMP Validated?
Securing your EU GMP validation for cannabis can take months. Submitting a strong documentation package makes your auditor’s work simpler and can accelerate validation. Ziel can reduce the time it takes for your operation to become EU GMP validated by providing you with all the IQ, OQ, and PQ documentation for your Ziel RFX. We’ll complete the IQ and OQ documentation during installation, and then start you on PQ during commissioning, working with you all the way through to submitting your documentation package to your local auditor.
How Much Validation Effort Will Ziel RFX Create for My Team?
The Ziel RFX will create minimal workload for your team. We’ll work together with your quality control team to complete all the IQ, OQ, and PQ documentation for your Ziel RFX or APEX 7 machines. We can also customize the documents to meet necessary local regulatory requirements, and when the auditor returns with questions and comments, we’ll be with you to address them and get you over the finish line.
What Does Ziel Provide for EU GMP Validation for Cannabis?
Ziel provides the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documents for both our RFX and APEX 7 machines and software, as well as all the supporting documents for traceability. We are the only microbial decontamination solution on the cannabis market to deliver an EU GMP validation-ready turnkey package.
Can We Deploy Quickly Without Custom Development?
Yes, you can incorporate the Ziel RFX into your EU GMP-validated operation without custom development. Our documentation can be tailored to meet local regulatory requirements if needed.
What’s Included in Ziel’s EU GMP Validation-Ready Turnkey Solution, and What Do We Still Need to Write Ourselves?
In Ziel’s EU GMP turnkey package, you’ll receive all of the IQ, OQ, and PQ documentation for your Ziel cannabis decontamination machine, as well as all supporting documents for traceability. Our software has also been validated. You will still have to complete the final validation work and other documentation and paperwork for your facility, related to upstream or downstream processes, if you don’t already have it.
Explore all our products
Ziel designs, builds and installs our processing lines with your requirements and product in mind. We will partner with you to design and build custom process systems that will best meet your goals.
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