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. We were founded in 2015, and are a US based service disabled veteran owned small business. Orion’s staff consists of respected scientists and engineers with subject matter expertise in their respective fields. 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 assist our clients in developing 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 process from the beginning and that regulations are met, avoiding costly retrofits after the facility is built.
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 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
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:
- Canna-Tech Sydney, Australia – October 2018
- BNN Bloomberg Commodities – “Helping the Cannabis Sector Scale Up” – Aug2018
- 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
Justin holds a Master of Engineering degree and brings his process engineering background to Orion, with certification in Automotive and Aerospace Manufacturing, as well as ISO9001. His expertise is bolstered by his Lean Six Sigma Black Belt certification and significant experience in applied business management consulting. Justin has worked with numerous cannabis manufacturers to improve process efficiencies and identify key risks of processes related to manufacturing.
- Lean Six Sigma Black Belt
- Radiation Safety Officer
- Member, ASTM D37 Cannabis Committee
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
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.