2008 NIP Inspection(.pdf)

2008 TGA Inspection(.pdf)

2007 DOH Inspection(.pdf)

2005 FDA Inspection(.pdf)

2001 FDA Inspection(.pdf)

FDA Inspection Management (.pdf)

Details of the Validation Master Plan (.pdf)

Responsible Care Management System Verification
 

Responsible CARE^TM has been designed into the basic working philosophy of ScinoPharm. It is a voluntary management program designed to improve EH & S performance of the plant in general. It is specifically designed to prevent accidents or near-miss incidents that would adversely affect our employees, the community, the public or the general environment.

Environmental, Health and Safety ScinoPharm's EH & S programs have been established in accordance with the six codes of the U.S. Chemical Manufacturers' Association (CMA) Management Practices of Responsible CARETM. These six codes include Community Awareness and Emergency Response, Process Safety Management, Employee Safety & Health, Transportation Safety, Pollution Prevention and Product Stewardship. To protect our employee's safety and health, a system of containment and special material handling devices are mandated by our work practices SOPs. Process safety is enhanced by our plant-wide MSDS and toxicity information database, in compliance with U.S. OSHA standards.

Responsible CARE Program (.pdf) ScinoPharm Taiwan Awarded Responsible Care Management System Verification Environmental Health & Safety Practices (.pdf) More on Waste Treatment Practices (.pdf)

In addition, an on-site program is in place to manage chemical reactive hazards and scale-up safety assessments using several hazard prediction instruments such as the Differential Scanning Calorimeter (DSC).

Employee safety and health records are compiled in accordance with U.S. OSHA guidelines, allowing direct comparisons to the safety statistics maintained at all U.S. chemical and pharmaceutical plants.

Waste Treatment

ScinoPharm has the on-site capability to treat all of its wastes, including biodegradable waste waters, burnable wastes, solid waste and air pollutants.

Biodegradable wastes are treated in a combination Activated Sludge system and a Tubular Ultrafiltration (UF) unit supplied by Zenon, Inc. Sludge from this unit is separated, filtered and trucked to a government-approved incinerator in the Tainan Science Industrial Park. Treated wastewaters, as well as storm waters are piped to the tertiary bio treatment system in the Science Industrial Park. Hazardous solid wastes are either incinerated in the government incinerator or properly buried in a government-approved class A Hazardous Waste site in Taiwan. Non-hazardous waste is shipped to a Sanitary Landfill operated by a certified class B waste disposal vendor. All vapors and particulate emissions from either the R&D facility or the production units are captured and removed using caustic scrubbers followed by activated carbon absorber units. Recovery of solvents is practiced whenever possible.