North America’s WHO GMP, ICH Q7, and PIC/S certified hemp processor.
Vantage Hemp’s purpose-built facilities were designed from the ground up with safety and quality top of mind. Designed by a highly experienced management team, Vantage’s GMP compliant processes exceed industry standards and result in a premium, pharmaceutical grade product which is delivered safely and reliably. At Vantage Hemp, all of our Pharmaceutical Grade CBD and CBG APIs are derived from industrial hemp that is exclusively grown, harvested and dried in the United States by GACP certified growers qualified through our Biomass Compliance Program. Our Quality Assurance (QA) and Quality Control (QC) systems are aligned with internationally recognized Current Good Manufacturing Practices (cGMP) for pharmaceutical quality including WHO GMP, FDA 21 CFR 210/211, ICH Q7, and PIC/s standards.
Pharmaceutical Quality Milestones
2019 – 2020
Colorado Department of Public Health and Environment (CDPHE) certification
2021 – 2022
Drug Master Files for CBD Isolate and CBD Distillate registered with FDA.
WHO GMP and ICH Q7 certification from SGS
2023 – 2024
Inspection and PIC/S certification by the Therapeutic Goods Administration of Australia
2025 – 2026
(in progress)
ANVISA: CBPF
EMA: ASMF
EMA: CEP
“We built the facility to be compliant with Current Good Manufacturing Practices for Active Pharmaceutical Ingredients.”
– Deepank Utkhede, Chief Operating Officer at Vantage Hemp
Ask Vanna
I’m Vanna, your Pharmaceutical Quality Audit Assistant.
I can answer the most common questions from all of the quality audits we see here at Vantage Hemp. While I am not meant to replace a live engagement with our QA team, I can accelerate your early stage qualification process.
- Ask me any one-off questions from a typical cGMP vendor qualification process
- Let me guide you through a variety of cGMP documentation
- Quality Audit Answer Guide
- cGMP Compliance Package
- Site Master File
- cGMP Quality Manual
- Upload your own Vendor Audit questionnaire and allow me to provide a list of answers.
Please note,I’m not great at figuring out check boxes, symbols, and tables within tables. For best results, save your questionnaire as a text file before uploading. MS Word documents should be saved as .txt with encoding for best results.
Pharmaceutical Quality Standards in cGMP
WHO GMP
Ensures compliance with internationally recognized guidelines outlined by the World Health Organization for Good Manufacturing Practices, as applicable to Active Pharmaceutical Ingredients (APIs). This certification governs the implementation of validated analytical methods, stringent quality management systems (QMS), and continuous process monitoring to ensure batch consistency, traceability, and compliance with pharmacopeial standards (e.g., USP, Ph. Eur.).
It guarantees that all operations, including sampling, testing, and release, are performed under controlled conditions, meeting regulatory requirements for pharmaceutical-grade cannabinoid production and facilitating market access in jurisdictions requiring GMP-compliant Pharmaceutical Quality APIs.
21 CFR 210/211
Provides the FDA framework for Good Manufacturing Practices for Finished Pharmaceuticals. We follow these regulations to ensure that our finished CBD products are manufactured, processed, and packaged in ways that guarantee quality, purity, and safety.
Process Validation: We ensure that every phase of production is thoroughly validated, and we maintain strict documentation at every step.
In-Process and Final Product Testing: Our in-process controls and final product tests are designed to ensure that our products meet all required standards before they are released to the market.
ICH Q7
Designed to ensure the consistent quality and safety of Active Pharmaceutical Ingredients (APIs).
Material Management: We strictly control our raw materials, intermediates, and APIs throughout the manufacturing process.
Process Validation: Detailed IQ/OQ/PQ protocols for all equipment, ongoing process monitoring.
Documentation and Change Control: All documentation, including batch records and SOPs, is managed through our eQMS
Contamination Control: We use cleanrooms with HEPA filtration and strict gowning procedures
Audits and Inspections: We conduct regular internal and external audits
PIC/S
An internationally recognized framework that harmonizes GMP standards between regulatory authorities. Our commitment to PIC/S Guide to GMP (PE 009-15) ensures that our operations are globally compliant.
Batch Traceability: Every batch is fully traceable from raw material intake through to the final product. This is vital for recalls or investigations in the case of quality deviations.
Quality Risk Management: Our approach incorporates risk-based assessments, from supplier management to process validation and in-process controls
Personnel Training and Qualification: All training records are meticulously maintained within our eQMS, and we regularly assess staff to ensure ongoing compliance.
How does Vantage Hemp support IND, clinical trials, and commercialization?
Vantage Hemp supports Investigational New Drug (IND) applications through its comprehensive capabilities in pharmaceutical-grade manufacturing, particularly for hemp-derived CBD products. Key aspects of support include:
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- Drug Master Files (DMF): Vantage provides Drug Master Files to the FDA, detailing manufacturing processes and materials used in production. This provides drug developers with critical information for their regulatory submissions, streamlining the IND process.
- cGMP Compliance: Vantage Hemp operates under stringent Good Manufacturing Practices (GMP) including WHO GMP, FDA 21 CFR 210/211, and ICH Q7 standards. This ensures that all products meet high quality and safety requirements, which is essential for IND applications.
- Collaboration in R&D and Clinical Trials: Vantage has experience in collaborating with pharmaceutical companies throughout the R&D phase, providing scalable solutions for clinical trial supplies, including active and placebo batches. This partnership approach aids clients in navigating from IND submission to successful commercialization.
- Product Testing and Quality Assurance: Vantage conducts full panel testing at each stage of the manufacturing process, ensuring product safety and efficacy, which are crucial for IND submissions.
- Scalable Solutions: Vantage’s ability to provide a range of pharmaceutical-grade products, from APIs to finished goods, helps clients meet the variable demands of clinical trials and supports extended development phases.
Does Your Heart Ache for a Quality CBD API Supplier?
End the heartache with Vantage Hemp
In developing novel drugs for novel indications, pharmaceutical companies and drug developers must have faith that their API provider and contract manufacturer can stay with them for the long haul. Vantage invests in world-class pharmaceutical manufacturing capabilities with a long-term view toward the CBD market.
View our case study Formulation Development and cGMP Clinical Batch Manufacturing to learn more.
