Who is Orion GMP Solutions?
Orion GMP Solutions (Orion) is a Pharmaceutical Consulting Firm that brings expertise in Pharmaceutical Quality Management Systems (QMS) and Good Manufacturing Practices (GMP) to the international cannabis industry. Orion was established in 2015 out of Detroit, MI and is a veteran owned small business founded by Mr. Andrew Samann. Orion’s expert staff consists of respected scientists and engineers with years of experience in their respective fields. Our staff’s diverse background allows us to bring a wealth of knowledge to the cannabis industry and the development of world-class quality management systems. Our services span all stages of the business life cycle, from project management and facility design to implementation of International GMP and QMS. Our experience with clients in the pharmaceutical, cosmetics, nutritional supplements, aerospace, and cannabis industries provide us with the expertise to ensure that you have industry leading controls in place.
We partner with our clients to develop their processes with a strong focus on quality and adherence to applicable regulations. We work closely with all stakeholders of your project to ensure that quality is engineered into the operation from the very beginning and that regulations are met, avoiding costly retrofits after the facility is built-out and changes are difficult.
Orion continues to develop international relationships with experts and marquee clients across the industry. We are committed to internationally harmonized industry standards that protect consumer safety as demonstrated through our leadership positions within the D37 Cannabis Standards Committee of ASTM International, a standards development organization with over 30,000 members from over 140 countries.
Orion’s mission is to provide the highest level of customer service to each of our clients so that they may set new standards of quality in the cannabis industry. It is our belief that through a consistent approach to risk-based systems we can help this blossoming industry be the shining example of what true quality represents in the marketplace.
ORION Project Highlights
- Publicly traded Canadian LP (Licensed Producer) – Implementation of ICH GMP Systems, leading to International GMP Certification
- Canadian LP – Merger and acquisition due diligence including audit to EU GMP guidelines required prior to acquisition
- California Type 7 Manufacturer – Performed all pre-licensing activity through delivery of operational management template, standard operating procedures specific to hydrocarbon extraction through thin wiped film distillation. Represented client to City Planning Commission, City Council, and Mayor, resulting in successful
- Canadian LP – EU GMP implementation including gap audit, project management and EU GMP implementation of large-scale multi-facility company. Developed corporate GMP and Quality Management
- DEA Schedule 1 FDA cGMP Compliant Applicant – Performed GMP facility design, FDA GMP compliance strategy for pharmaceutical grade research materials, application content development for Drug Enforcement Agency and Food and Drug Administration.
- Pharmaceutical supply chain audit of 6 sites for pharmaceutical development firm. Audited to FDA and EU GMP for Contract Manufacturing, ISO 17025 testing laboratory, Good Laboratory Practices for non-clinical laboratory, and Good Clinical Practices for clinical Contract Research
- West Coast Fruit and Vegetable Producer – Successfully aided client in facility design and quality management system build out to adhere to USDA & FDA regulations in their addition of cannabis (THC-rich) and hemp (CBD-rich) production
Orion GMP Solutions Consulting Staff
The Orion team is comprised of subject matter experts spanning the science, engineering, and business fields. We work closely on all projects to provide you with a thorough assessment of all risks involved in managing and operating your business. This list comprises the primary consultants that are subject matter experts and perform the majority of our consulting work.
Founder, Principal Consultant, and Chief Executive Officer
Andrew is the founder of Orion GMP Solutions and serves as the Chief Executive Officer and Principal Consultant. As a Sergeant in the United States Marine Corps, he served two tours in Iraq as an NCOIC, leading a team of Marines responsible for quality maintenance management and documentation of over 400,000 life limited critical parts on UH-1N and AH-1W attack helicopters.
Following the Marines, Andrew earned a Bachelor of Science in Biochemistry and worked at the University of Michigan as a bio-analytical chemist, publishing several articles in peer reviewed scientific journals. Andrew’s experience spans the fields of bio-analytical chemistry and purification; including pharmaceutical manufacturing of Active Pharmaceutical Ingredients under FDA and International GMP guidelines in an FDA Registered, DEA Schedule 1 Facility.
- United States Marine Corps Veteran, Sergeant, Honorable Discharge
- Executive Committee Member, ASTM International D37 Cannabis Committee Subcommittee Chairman, ASTM D37.02 Subcommittee on Quality Management Systems
- SGS Lead Auditor
Cannabis Speaking Engagements:
- Cannabis Radio – “Quality Management Systems in Cannabis” – December 2019
- Cannabisalud Mexico City, Mexico – October 2019
- Canna-Tech Sydney, Australia – October 2018
- BNN Bloomberg Commodities – “Helping the Cannabis Sector Scale Up” – August 2018
- MJBiz International, Toronto, Canada – August 2018
- ASTM D37 Cannabis Supply Chain Standardization Workshop – June 2018
- Emerald Science Conference San Diego, California USA – Feb 2018
- ASTM D37 Cannabis Standards Committee New Orleans, Louisiana USA – Jan2018
- Canna-Tech London, United Kingdom – Oct 2017 (Invited)
- ASTM D37 Cannabis Standards Committee EU Workshop Berlin, Germany – Oct2017
- ASTM D37 Cannabis Standards Committee Toronto, Canada – Jun 2017
John S. Abrams, Ph.D.
Chief Scientific Officer
John S. Abrams, PhD. has over 40 years of experience in the Biotechnology Industry, including several decades of senior executive science leadership. He holds a BA degree in Biochemistry from UC Berkeley, and a PhD in Biochemistry from McGill University. He has authored over 100 scientific publications and holds over a dozen issued patents. His scientific focus has included Antibody Technology, Immunology, and more recently, Cannabis Science. Dr. Abrams has deep experience with early research program design, implementation, and team creation. He has been consulting for over 15 years.
Dr Abrams, a Cannabis Science Subject Matter Expert specializing in Metrology and Chemotyping, has invented a patent pending, icon-based system that communicates natural product content complexity simply and easily to consumers. Dr Abrams has a deep expertise in the statistical and graphical treatment of complex data which lead him to spearhead The Dosing Project, a web-based observational clinical study platform. Dr Abrams recognition as a Key Opinion Leader has led to his appointment as Scientific Director of The Emerald Conference.
- Emerald Science – Scientific Director, 2019 Emerald Science Conference
- Fireflower Technologies Inc. – Founder, Chairman and CSO
- The Clinical Endocannabinoid System Consortium, Inc. – Founder, Chairman and CSO
- Association for Responsible Medicinal Access (ARMA) – Member of Board of Directors
- PharmLabs LLC (SD) – Ad Hoc Cannabis Science Consulting
- Abrams BioConsulting, San Diego, CA
Managing Consultant and Chief Operations Officer
Justin holds a Master’s and Bachelor’s degree in Materials Science and Engineering with a diverse background across multiple facets of an operational business. Justin began his career managing day to day quality assurance laboratory operations for one of the largest global automotive ceramic monolith producers in the world before expanding to oversight of ceramic powder performance and quality to 7 global sister sites. In addition to a very strong quality background, his engineering career continued into application and new product development with a Joint Venture company engaging with General Electric to build state-of-the-art ceramic hot sections components within the Aerospace industry.
Justin’s engineering expertise is bolstered by his significant experience in applied business management consulting utilizing Lean and Six Sigma implementation methodology. Justin is a Six Sigma black belt that has worked with countless manufacturers across the industry spectrum including cannabis to improve process efficiencies and identify key process risks related to manufacturing.
- Lean Six Sigma Black Belt (ASQ)
- Radiation Safety Officer
- Member, ASTM D37 Cannabis Committee
Senior Consultant and Cannabis Quality Engineer
Cary holds a Bachelor’s degree in geology, and another in chemistry. Cary worked as an analytical chemist at Dow Chemical for 10 years before moving on to Quality Management as the corporate QC/R&D Manager for Duro-Last. At Duro-Last, Cary was the principle for the development of Duro-Last’s Lean-based QMS. Cary was the principle inventor and patent holder for a modified thermoplastic polyolefenic single-ply roofing material.
Additionally, Cary was the Lab Manager for the Domino Sugar Refinery’s Quality Laboratory, where he became an expert in the SQF and GMP-based QMS governing the sugar refining process. Cary has been an ASTM officer since 2005. He has chaired or vice- chaired multiple sub- committees.
As an ASQ Certified Quality Engineer (CQE), and quality professional, Cary has provided expertise in Lean Manufacturing and QMS implementation, using such tools as, FMEA, SPC, Value Stream/Process Mapping, and SOP creation. Cary has additionally served as Chairman for both the New Orleans and Saginaw local ASQ Chapters as well as Deputy Director for ASQ’s Region 10.
Cary has published 3 peer-reviewed Technical papers, 7 ASTM standards, 2 books, and dozens of freelance articles in multiple publications.
- ASQ CQE
- ASTM Vice-Chair D37.02 (Cannabis Subcommittee on QMS)
- Subject matter expert on the development team for the ASQ’s Cost of Quality short
- SQF expert
- Quality Auditor
- Vice-Chairman New Orleans ASQ Section
Senior Consultant and Cannabis Quality Auditor
Maribel is an internationally recognized cGMP auditor that has served a wide array of industries and Fortune 500’s such as Apple, Pfizer, General Electric among many others during her 15 years of experience.
Maribel has served all facets of the business spectrum over the course of her career having held positions such as Senior Quality Engineer for General Electric as well as Director of Quality Assurance and Regulatory Compliance for a consulting firm servicing the Biotechnology, Medical Devices, Cosmetics/OTC, Pharma and Radiopharmaceutical industries.
Her experience ranges from applied lean six sigma to business operations supporting GMP, FDA remediations, OTC compliance readiness, ISO certification readiness, global technology transfer and product development applications in heavily regulated environments.
She holds a Bachelor’s degree on Chemical Engineering with a concentration in Industrial Biotechnology. Maribel is a material expert on a variety of nationally and internationally recognized current good manufacturing practices guidelines and regulations.
- ASQ Quality Auditor Certified / GE Internal Auditor Certified for ISO 13485
- Exemplar Global ISO 9001:2015 Lead Auditor Certified
- Lean Six Sigma Black Belt Certified
- Active Member of ASTM D37 Committee
- Fully Bilingual (English and Spanish)
Cannabis Speaking Engagements:
- Subject Matter Speaker for Auditing in the Cannabis industry at the ASQ Audit Division Conference, Florida – 2019
- CannabiSalud 2019 Mexico City, Mexico – October 2019
Allison Weber Ledbetter
Allison was named Account Manager at Orion GMP Solutions in June of 2018 and is responsible for assisting CEO, Andrew Samann, as well as his consultants, on company and project needs and coordination of projects with clients. Ms. Ledbetter’s past experience with assisting executives and clients began with her internship at a leading entertainment company, Paramount Parks, by assisting the CEO. After Paramount Parks she was the Executive Assistant for the Founder and CEO of Kings Leisure Partners, a consulting company whose focus was on organizational culture, leadership, and strategic turnarounds in the theme park industry.
Ms. Ledbetter holds a Bachelor’s Degree in Criminal Justice from Gardner Webb University, is a certified Notary Public, and attended the University of Chapel Hill Paralegal Certificate Program in 2016. Prior to joining the Orion team, she was a paralegal in law firms who specialized in family law and real estate. Her knowledge of law coupled with her account management experience in the entertainment industry, supports Orion GMP Solution to reach industry- leading performance.