Intellectual Property Protection, Quality Assurance, and Regulatory Compliance
Intellectual Property Protection
Eastar develops innovative chemistries and regularly transfers technologies from its customers and partners. We view Intellectual Property as the lifeline of the ongoing success between our company, customers and partners. We are diligent and committed in its protection.
Eastar is a corporation of USA and operates under the US legal system. This provides our customers more assurances in signing contracts and agreements with us than engaging directly with a Chinese company.
For over 25 years, we have vigorously enforced our company’s strict IP protection procedures. Through our proven methods, Eastar has built a strong IP protection track record for our company internally and for our partners and customers. We will continue this tradition.
Quality and Regulatory Compliance
Eastar is committed to delivering quality products and service that fulfills its customers' needs and expectations. Eastar focus on the integrity of our products, their safe manufacture and distribution and the compliance with environmental and other relevant regulations.
Eastar operates process-oriented quality management systems for production of its specialty chemicals. Quality management at Eastar uses tools which are well-established and inspired by TQM, ISO and Six Sigma.
For manufacturing of products for the life science industry, Eastar is fully committed to the current Good Manufacturing Practices (cGMP) comprising the internal GMP policy as well as local law and international guidelines adopted by the U.S. Food and Drug Administration (FDA) and the Pharmaceutical Inspection (PIC) in Europe. At the same time, Eastar abides by GMP regulations of the Chinese SFDA for the supply of products to the Chinese pharmaceutical industry.
Eastar's Quality Assurance team is independent of the production and supported by recognized industry experts and consultants.
Even though each of Eastar's affiliate production sites operates its own quality control laboratory, Eastar's corporate quality control (QC) department is responsible for the final product release for all Eastar affiliate facilities, subcontract manufacturing sites, and suppliers. When appropriate, Eastar QC department will test and approve every lot and shipment before final release for shipment to customer. Eastar maintains well-equipped laboratories and retains a well-trained analytical staff. Eastar also works cooperatively with third party laboratories in both China and USA when appropriate.
Eastar owners, management and employees understand the importance of upholding the highest standards in quality and compliance to regulatory requirements. Eastar has been and will continue to be diligent to implement our quality procedures and to excel in regulatory compliance.
Environment, Health and Safety (EH&S)
Eastar is committed to the safe handling of chemicals. Eastar developed and uses production processes designed to protect both employees and the environment. Our systems are in place and our staff trained regularly on safe operating procedures. Eastar is committed to achieve significant reductions in releases to air, land and water; major improvements in workplace and community safety; and supports research and test chemicals for potential health and environmental impacts. Eastar is committed to the continuous improvement of a product stewardship regimen to maximize the safety of production and handling, optimize performance as well as to minimize the environmental impact of our products and processes.
Management and Responsibility— We actively manage EH&S as an integral part of our businesses, operations and practices. We require our affiliates’ and our suppliers’ management to comply with the applicable laws and our internal and external EH&S requirements.
Environment and People— We strive to minimize the environmental impact of our operations and business practices. We maintain and continue to improve on a safe workplace environment for our employees and provide appropriate information and training.
Continual Improvement— We monitor our EH&S performance and measure the progress in order to continuously improve our EH&S system and performance.
Control and Auditing— We assess the EH&S risks before operating processes, applying technologies and handling products. We have emergency procedures in place and fast access to emergency response organizations and agencies to control and to limit the impact of incidents and threats. We periodically audit our affiliates’ and our suppliers’ manufacturing sites for EH&S performance and compliance.
Registration, Evaluation, Authorization and restriction of Chemicals (REACH) is a framework for regulation of chemicals in the European Union. It addresses the production and use of chemical substances and their potential impacts on both human health and the environment. REACH will require all companies manufacturing or importing chemical substances into the European Union in quantities of one or more per year to register these substances with a European Chemicals Agency. REACH also addresses the continued use of chemical 'Substances of Very High Concern' (SVHC) because of their potential negative impacts on human health or the environment. From 1 June 2011, the European Chemicals Agency must be notified of the presence of SVHCs in articles if the total quantity used is more than one ton per year and the SVHC is present at more than 0.1% of the mass of the object. Some uses of SVHCs may be subject to prior authorisation from the European Chemicals Agency, and applicants for authorisation will have to include plans to replace the use of the SVHC with a safer alternative.
Eastar has committed significant resources to understanding the details of REACH. Eastar, with its affiliate production sites and suppliers, have already developed a thorough plan and have carried out the necessary steps in its compliance. Eastar will continue to monitor any updates of REACH as it is developed and implemented, make adjustments as needed, to insure that we are in full compliance.