Quality and Environment
Quality Assurance System preserving quality of drug
Our quality assurance system “J-QS” is maintained in compliance with the latest global standard by continuous access to GMP regulatory information updated, while it is taken into consideration that the API contracted will be marketed all over the world. In J-QS, the following various kinds of SOP are completely in place to realize “Highest reliability”, upon the basis of which QC unit comprising Product Security Pharmacist, Quality Assurance Department and Quality Control Department, will assure the certain quality.
- ・Quality manual
- ・Change Control System
- ・OOS Control System
- ・CAPA Control System
- ・Validation System
- ・Deviation Control System
- ・Training Control System
- ・Self Inspection System
- ・Recall Handling System
- ・Other Control Systems
These systems are continuously reviewed by motivated employees all with earnest improvement will. Improvement measures toward “Highest Quality Control System easy to keep” are daily taken including such improvement as exuviating into easy-to-keep control rules or as promoting to adopt visual labeling and so forth. As being carried through from research stage, this spirit has formed the background for us to provide consistent GMP system from labo scale/pilot scale of development stage (investigational drug) through commercial production, and has been the basis for securing highest reliability in quality.
Current Certification Status
|FDA Inspections||2000 JPP-Ⅰ|
|2005 JPP-Ⅰ, JPP-Ⅱ|
|2009 JPP-Ⅰ, JPP-Ⅱ|
|2016 JPP-Ⅰ, JPP-Ⅱ|
|2018 JPP-Ⅰ, JPP-Ⅱ|
|2019 JPP-Ⅰ, JPP-Ⅱ|
|MFDS Inspections||2007 JPP-Ⅰ|
|AIFA Inspections||2012 JPP-Ⅰ|
Efforts for environmental conservation
Juzen obtained ISO 14001 (environmental management system) and is tackling the topics such as environmental conservation, compliance, energy saving by all employees.
And Juzen accepted EHS inspection from pharmaceutical megacorporation and is moving forward the correspondence for it proactively.
ISO14001Awarded certificate of approval ISO 14001(EMS)
“Clear Air”, “Clear Water”, “Abundant Green”
For the purpose of handling over the environment blessed with nature to the following generation, JUZEN recognizes it is our mission charged to us to endeavor to preserve the environment.
1. Not only contribute to society as a manufacturer of pharmaceutical substances along with the intermediates, but also endeavor to harmonize with local environment and maintain global environment through meeting the needs and expectations of stakeholders in business activities.
2. Promote effective utilization of resources and energies along with reduction of wastes at our business activities, and endeavor not only to prevent pollution, but also to achieve continual improvements while aggressively promoting the activities related to beneficial environmental aspects.
3. Observe not only environment-related laws & regulations and other requirements, but also endeavor to elevate our environmental control level further with our own self-imposed control requirements established.
4. Implement environmental assessment on our business activities, establish our environmental objectives, put them into practice, and endeavor to continually improve our environmental management system through periodical review of them to elevate our environmental performance.
5. Not only thoroughly notify Environmental Policy to the whole employees and the contract receivers working inside the premises of the organization, but also elevate the environmental awareness of individuals through continual training.
6. Reveal this environmental policy to the public.