cnenjpkr

客户中心

客户评价

您当前的位置:首页 > 客户评价

From Ardea Bio Science

The quality assurance (QA) unit consists of four full time GLP members, and members of the QAU attend SQA meetings every year. The QA manager has been RQAP-GLP certified since 2009. A sign at the entrance to the preclinical building identifies it as a GLP area and instructs to comply with all SOPs. Personal protective equipment standards are taken very seriously. All equipment for GLP use is clearly labeled as GLP. Equipment logbooks are maintained near each piece of equipment and all equipment records from previous years had been archived at the time of inspection. Pipettes are calibrated quarterly. Instruments in use for GLP formulation analysis all indicate the last date of maintenance and calibration and show the next dates due - labels are firmly secured to the equipment and instruments. In the event of power failure, power is switch- ed to generators within 10 minutes. Temperature and humidity in the test article storage room are monitored by a biannually calibrated thermo hygrometer. Sample storage environmental monitoring performed using SENSATRONICS.

The Medicilon archive meets regulatory expectatio- ns for security. The room is locked, it is accessible only by the archivist and entry to the room is tracked with a sign-in sheet. The Archive is protected by a water sprinkler system and archived materials are protected from water damage in plastic bags. Electronic archived materials are stored on CD/DVD in metal boxes locked in a separate cabinet, but within the same room. Pest control material is dispersed among the cabinets. Annual GLP refresher training is performed; training records are maintained in the group leader’s cabinets. Deviations from the SOPs and protocol in the reviewed method validation were properly documented and the impact appropriately addressed by the study director. QC review was clearly documented throughout the raw data. The QA statement indicated several inspections were performed and all equipment use was tracked appropriately...

Quality Control & Assurance

QC review was clearly documented throughout the raw data. The QA statement indicated several inspections were performed and all equipment use was tracked appropriately.


From SK Life Science R&D Park

The results of an intensive three days audit onsite of GLP systems and procedures, as well as site and personnel, operating systems and procedures, and raw data and final report from one non-GLP study lead to the conclusion that Medicilon is qualified and capa- ble of conducting non-clinical GLP studies in compliance with the US FDA GLP’s. The personnel who participated the audit were knowledgeable and professional. The results of an intensive thr- ee day audit as well as facilities and training records and proce- dures lead to the conclusion that the facility is qualified and capable of conducting in compliance with accepted standards of practice and the GLP’s.

High Caliber Scientific Staff

The personnel who participated the audit were knowledgeable and professional.


    Sepracor, (now Sunovion) a biotech company of Boston presented Excellent Perforamance Award to Medicilon in recognition of excellent services and contributions to its discovery research

    Roche R&D China presents a medal of Most Valuable Partner Award to Medicilon in recognition of excellent partnership

20选5开奖结果今天
麻将游戏下载单机版 福建36选7最新开 3d对应码金码今晚上 宝博棋牌官方下载app 老11选5为什么停了 浙江飞鱼 幸运赛车公式图 游戏网赚平台 一分快三app下载平台 北京pk105码倍投方案 浙江11选5*推荐 辽宁11选五中奖规则查询 多乐彩大赢家软件 5分快3官网 新疆11选5高频游戏 体育比分下载逛球街