Cary, NC – AEMSA continues to demonstrate the viability and practicality of the Reasonable, Realistic, and Sustainable approach to consumer protections and good product stewardship for E-liquid production. AEMSA manufacturing standards remain the only verified self-regulation and practices in the industry (globally). The FDA’s proposed deeming rules now make the need for comprehensive industry-specific GMPs obvious, as refillables are unlikely to remain on the market without them. We are now taking the next step! AEMSA is proud to announce a new working relationship with InstantGMP.
Some of our members have already been working closely with the InstantGMP team to further refine and develop GMPs focused on the manufacturing logistics specific and unique to E-liquid production. We were happy to learn from InstantGMP that our existing standards are already effective and thorough. However, they are not yet quite at the GMP level (more comprehensive documentation(s) being the primary area for improvement); we will be working together to help develop and bring industry-specific GMPs to our
E-liquid manufacturing members. AEMSA and InstantGMP will continue to set the example by educating the E-liquid manufacturing industry, the public, and regulators.
Dr. Soltero has over 40 years of pharmaceutical research and development experience. Prior to founding PharmaDirections, Inc. in 2003 and InstantGMP, Inc. in 2004, he was Executive Director of
Pharmaceutical Development and Analytical Chemistry at Nobex Corporation, where he led the strategic and project teams on oral insulin (licensed to GSK in 2002). Before that, he was Vice President of the Laboratory
Operations at Magellan Laboratories (now Catalent) and at AAI. He has managed Analytical Chemistry, Organic Synthesis, Peptide Synthesis, Microbiology, and Biotechnology contract research laboratories. At AAI
he was responsible for managing 300 staff in 8 labs with combined annual revenue of over $30M.
Dr. Soltero has also managed ethical and OTC pharmaceutical R&D groups. SmithKline Beecham Consumer Healthcare employed him as their Worldwide Head of Analytical, Microbiology, and Stability R&D. He was also responsible for the worldwide unification of all Laboratory Information Management systems. At Johnson & Johnson, he was Manager of Pharmaceutical Analysis, where he conducted biotechnology research and was a leader of the Platelet Derived Growth Factor project (now on the market as Regranex). At Berlex
Laboratories, he managed the Analytical R&D laboratory and the Pharmacy R&D formulation development programs. He joined Ciba-Geigy in 1967, where he held various positions of increasing responsibility
from Formulation Technician to Senior Scientist/Supervisor in Biopharmaceutics and Preformulation Laboratories. He has over 45 scientific publications and presentations in the areas of
biopharmaceutics, automation, and protein product development. He is the inventor of 22 patents in the areas of oral protein formulations, recombinant protein processes, drug delivery technologies, sustained
release products, and electronic quality and manufacturing systems.
InstantGMP, Inc. was founded in 2004 to develop web-based software for manufacturing products that must comply with current Good Manufacturing Practices (cGMP) and FDA requirements with the goal of making GMP production easy. Their software systems were developed to meet the standards of cGMP, GAM, and 21 CFR Part 11. InstantGMP has already been working with E-Liquid manufacturers, and they now have a designated focus in this industry. They have a website section identified as “InstantGMP Vape” with sub categories for E-Liquid Manufacturing Software, E-Liquid calculator, E-Liquid SOPs, E-Liquid manufacturing process, FDA regulations timeline, and a Vape glossary.