PIC/S GMP Business Service
- Contract Manufacturing
TTY manufactures cytotoxicity injection and capsule as well as non-cytotoxicity lyophilized injection, tablet and capsule. It is able to provide stable and high-quality manufacture performance, implementation of manufacturing technology transfer based on client’s requirements, batch product scale-up planning as well as execution of relevant validation operations in order to achieve purpose of product commercialization manufacturing.
- GMP Tutoring
In addition to passing Taiwan health authority’s PIC/S GMP inspection, TTY also passed official GMP factory inspections conducted by numerous countries of Europe, U.S. and Japan. TTY is equipped with complete and qualified quality management system and teams which are able to assist and tutor preparation for domestic or offshore GMP factory inspection as well as establishment of quality system.
- Contract Laboratory
TTY’s QC laboratory is not only installs complete microbiology and sterility analysis laboratory but it is also equipped with analysis capability for special preparations of liposome and lyophilized liposome. This laboratory complies with relevant analysis method and facilities which are continuously updated in pharmacopoeias by advanced countries in Europe, U.S. and Japan. The laboratory is equipped with the capability of analysis method development, technology transfer and validation. Services of contracted chemical and microbiology tests as well as test method development and test method are accepted.