MedPharm Completes GMP Audit of Morrisville Manufacturing Facility
October 6, 2022
MedPharm recently completed two client audits that investigated the company’s compliance with Good Manufacturing Practices (GMP), as well as internal Quality Systems. MedPharm is pleased to announce that both audits were passed with no major observations.
This achievement reinforces MedPharm’s ability to provide clinical and commercial semi-solid manufacturing services to the pharmaceutical market in compliance with regulatory standards. Additionally, MedPharm’s policies, procedures, and Quality Management System (EtQ) were thoroughly vetted. MedPharm was designated an approved vendor by both clients.
MedPharm President and Chief Executive Officer, Eugene Ciolfi, said: “At MedPharm, we are proud of our audit results and are excited to further support clinical through commercial production services to the pharmaceutical industry, especially for our existing clients we currently serve with formulation and performance testing expertise.”
These evaluations of MedPharm’s systems and compliance with GMP regulatory standards are further confirmation of MedPharm’s committment to providing topical clinical and commercial manufacturing services that clients can outsource to with confidence. MedPharm’s GMP-specific facility, which has been fully operational since Summer 2021, was custom built to meet client needs and provide the gold standard in topical manufacturing services.
MedPharm is the world’s leading contract provider of topical and transdermal formulation development and manufacturing services. Our experts specialize in reducing risk and accelerating development times for generic and proprietary pharmaceutical customers through cost-effective and industry-leading performance testing models. Well-established as the global leader in dermal and transdermal product development, MedPharm also offers innovative solutions for airway, ophthalmic, otic, ungual, and other topical preparations. With locations in both the US and the UK, MedPharm is the CDMO of choice for developers around the globe.