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 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 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 on 22 patents in the areas of oral protein formulations,
recombinant protein processes, drug delivery technologies, sustained
release products, and electronic quality and manufacturing systems.
About InstantGMP
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, GAMP 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.