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.
Like all of the TNF inhibitors, infliximab is an expensive medication, costing about US$900 for a 100 mg dose, and within the United States is covered by almost every medical insurance plan (though caps on many plans make it possible to be covered for only a subset of treatments in the course of a year). [ citation needed ] Infliximab is supplied as a sterile, white, lyophilized (freeze-dried) powder,  so must be reconstituted and administered by a health care professional, usually in a hospital or office setting.  For this reason, it is usually covered under major medical insurance rather than prescription drug coverage. The loading regimen for all approved indications occurs at weeks 0, 2, and 6 at the above dosages.