Aptar Pharma Announces GMP Certification at Nanopharm, Strengthening Its Integrated Pharma Services Offering
MHRA certification supports Nanopharm’s GMP analytical testing capabilities and Aptar Pharma’s commitment to regulatory excellence
Aptar Pharma, a global leader in drug delivery, dosing, protection technologies and services, today announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a Certificate of Good Manufacturing Practice (GMP) Compliance following its inspection of Aptar Pharma’s Nanopharm facility in Wales. Nanopharm specializes in the product development and analytical testing of orally inhaled and nasal drug products (OINDPs), supporting pharmaceutical companies from early preclinical development through to regulatory submissions and commercialization. The certification represents an important milestone in the continued development of Nanopharm’s quality systems and regulated analytical capabilities.
The inspection evaluated Nanopharm’s pharmaceutical quality system, facilities and operational practices against applicable regulatory requirements, with no critical observations. Nanopharm had already been operating in accordance with GMP requirements, delivering services in support of OINDP development. The first MHRA inspection and resulting GMP certificate confirm the MHRA’s conclusion that the inspected facility complied with applicable GMP requirements at the time of inspection. It also enables the site to provide additional services that fall within the scope of the inspection.
