KriSan Biotech has established an independent Quality Management (QM) team to build up a quality system that complied with FDA. This is to ensure the manufacturing activities performed at KriSan Biotech are under CGMP manners. Dedicated QM team is assigned to ensure all documentation and records, SOP’s and laboratory controls are well maintained. This group is also responsible for internal audit, reviewing batch record preparation and execution as well as analytical support. The QM team also works closely with customer to facilitate site audits, implement special requests and manage any GMP issues that arise during the manufacturing progress.
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Aug 2, 2011
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