Inspection opens door for company to increase production of user-friendly solid oral dosage forms for the US
Aerial view of the Wolfratshausen production plant
Hermes Pharma, a division of Hermes Arzneimittel and Europe's largest developer and manufacturer of user-friendly solid oral dosage forms, recently completed a successful inspection by the US Food and Drug Administration (FDA) of its production facility located in Wolfratshausen, Germany. The inspection stemmed from Hermes Pharma’s status as a manufacturer of food supplement products to the US, and marks the first routine inspection of a Hermes Pharma facility by the FDA.
The Wolfratshausen facility, coupled with a production facility in Wolfsberg, Austria, enables Hermes Pharma to support global customers looking to license in user-friendly dosage forms for distribution and sale in the US. The two plants are equipped with very similar production lines to ensure that there will be no interruption to supply. The service has proven popular with the pharmaceutical industry, with 10 of the top 15 global pharmaceutical companies currently working with Hermes Pharma.
User-friendly dosage forms such as instant drinks, orally disintegrating granules, lozenges, and effervescent and chewable tablets represent a rapidly growing opportunity in the food supplement market, especially for patients who find swallowing pills difficult. They are also gaining significant traction in the pharmaceutical sector as companies seek to better meet the needs of patients, while diversifying their product portfolio, strengthening their brands and extending product lifecycles.
‘This represents an important milestone for Hermes Pharma as the company steadily increases its manufacturing support for pharmaceutical companies around the world, especially those that seek access to the US marketplace or are already operating in the country,’ said Dr Thomas Hein, Director of Sales and Business Development, Hermes Pharma.
We viewed this as an opportunity to showcase our best-in-class, highly automated manufacturing plant that combines unique technology and expertise to develop and manufacture user-friendly dosage forms
The inspection covered thorough reviews of general systems, including training, equipment calibration and qualification, standard operating procedures, protocols and methods. It also appraised Hermes Pharma’s Hazard Analysis and Critical Control Point (HACCP) system, which is designed to identify and control specific hazards to ensure the safety of food products. Upon completion, the FDA investigator reported no adverse findings and did not issue a Form 483.
‘The successful inspection of our Wolfratshausen production site is a tremendous form of validation for our team and facility,’ said Dr Daniel Bracher, Director Quality at Hermes Pharma. ‘We welcomed the routine inspection and worked closely with FDA before, during and after the visit. ‘We viewed this as an opportunity to showcase our best-in-class, highly automated manufacturing plant that combines unique technology and expertise to develop and manufacture user-friendly dosage forms.’
More than 800 million effervescent and chewable tablets are manufactured annually in Hermes Pharma’s production plant in Wolfratshausen. Opened in 1994, the plant was optimised for the manufacture of moisture-sensitive effervescent tablets as well as chewable tablets. Weighing, granulating, mixing, tabletting and packaging take place in automated, closed systems spreading across 12,400m2. Rigorous Quality Control ensures compliance with all Good Manufacturing Practice (GMP) requirements, regulatory demands and client specifications.