Our manufacturing, quality control, and logistics base, Ueno Techno Center,
has a highly automated eye care production line that enables us to produce
a wide variety of products. The high quality assurance system and flexible
production lines cultivated in pharmaceutical manufacturing, advanced aseptic
and foreign material control technology, and centralized control of test
data using a Laboratory Information Management System information management
system (LIMS), etc. enable high quality and highly efficient production
systems. The center was the first Japanese pharmaceutical manufacturer's
facility to comply with FDA Part*1, and has also acquired ISO13485*2 and
CE marking*3, and is actively promoting the provision of products overseas.
*1. FDA Part 11 is standards for electronic records management stipulated by the U.S. Food and Drug Administration.
*2. ISO 13485 is an international standard on quality assurance specifically for medical devices.
*3. CE marking is used to indicate a product has passed European safety testing.