Pharmaceutical Quality
North America’s WHO GMP, ICH Q7, and PIC/S certified hemp processor.
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.
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.
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.
Does Your Heart Ache for a Pharmaceutical Quality CBD 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.
Pharmaceutical Quality – Clinical Trials
Work with Vantage Hemp to support your investigational new drug, clinical trial, and commercialization needs. Our team of experts has deep experience in pharmaceutical manufacturing and the journey from IND to commercialization. We understand the R&D and clinical trial process as you work through your drug development cycles.
The Drug Development Journey
Project Initiation
Team Formation
Project Governance
Workstreams: Regulatory and Commercial
Kick-off Meetings
Project Monitoring and Reporting
Manufacturing Planning
Pre-formulation and formulation development using client cGMP SOPs
Development of novel cGMP SOPs as required by client or regulator
Manufacture, release, and perform stability testing for cGMP placebo clinical batch
Manufacture, release, and perform stability testing for cGMP active clinical batch
Phased studies – clinical batch planning, manufacturing planning (includes active and placebo), and distribution (finish & fill) support
Demand planning and scaling for full commercialization
Prototype/Fill/Test
Formulation Development
Product Development
Materials Sourcing
Clinical Product and Finished Product Manufacturing
Release and Testing of Pre-clinical and Clinical Supplies
Required Studies
Support all required DEA requests, drug substance quantities, laboratory activity reports
Support regulatory filings for FDA, NIH, other bodies
Conduct solubility and stability evaluations of the required APIs
Identify excipient classes and conduct as needed compatibility screening
Perform drug solubility testing and analysis
Pharmaceutical Quality FAQs
What is Pharmaceutical Grade CBD?
Pharmaceutical Grade CBD products are created and tested in a laboratory setting to meet the compliance standards of the pharmaceutical industry. These include WHO GMP, FDA 21 CFR 210/211, and ICH Q7. Additionally, Vantage Hemp’s submission of a Drug Master File (DMF) to the US FDA indicates that all of Vantage’s products are manufactured using high-quality ingredients and under strict guidelines for purity, safety, and efficacy.
What is ICH Q7 certification, and why is it important?
Anyone who manufactures, tests, or packs pharmaceuticals or active pharmaceutical ingredients (APIs) must follow strict quality standards set forth by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH Q7 lays out these quality standards for Good Manufacturing Practices in the pharmaceutical industry. To obtain ICH Q7 certification, a company must pass a rigorous audit of its facilities, equipment, personnel, and quality control procedures.
What is cGMP CBD?
Current Good Manufacturing Practices (cGMP) is a product safety protocol that companies must follow during the CBD manufacturing process. cGMP CBD products are formulated in a way that human error is eliminated and the ingredients used have been tested, examined, and properly processed to create a finished product. cGMP ensures current innovation processes and production methods follow established scientific standards for data capture, data analysis, record keeping, and product labeling – and are constantly updated to the highest global standards.
What is WHO GMP and FDA 21 CFR 210/211 and why do they matter?
WHO GMP (World Health Organization – Good Manufacturing Practices) and FDA 21 CFR 210/211 (Food and Drug Administration Code of Federal Regulations Title 21) are guidelines that provide a framework for manufacturing quality pharmaceutical products. WHO GMP covers all aspects of production from raw materials used across the supply chain to the packaging and labeling of finished products on pharmacy shelves. Most countries have adopted WHO GMP as the gold standard in pharmaceutical manufacturing with FDA CFR 210/211 and ICH Q7.