大连金港安迪生物制品有限公司位于大连高新技术园区，双D港生物园区内。厂房于2003年建成，2004年4月获得了由国家食品药品监督管理局颁发的人用狂犬病疫苗(Vero cell)（小容量注射剂）的GMP证书，2006年8月获得该品种的冻干剂型的GMP证书。2005年，JGAD在狂犬病疫苗生产车间旁新建一厂房生产腮腺炎减毒活疫苗，于2006年12月获得GMP证书。JGAD每一次都顺利通过国家GMP的认证，没有严重缺陷项目。

2009年1月初，中国药品生物制品检定所在对狂犬疫苗监督检验中发现，辽宁大连金港安迪生物制品有限公司2008年生产的部分人用狂犬病疫苗中检出违法添加的核酸物质，属故意造假行为。其造假手段类似在奶粉中添加“三聚氰胺”，只是换成了名为“聚肌胞注射液”的添加物，添加后不仅在检测时能提高抗原含量，还可以使企业的生产成本降低约一半。但是，这样做的后果是，被狗咬伤的伤者注射疫苗后由于剂量不足，难以起到防疫的效果。事件原因在于企业“针对标准造假”，由于核酸不在疫苗的成分之列，正常的出厂检验不包含这项检测，监管部门只有对其产品做核酸成分的补充检查时，才能发现问题。药品监管部门按照药品管理有关法律法规的相关规定作出处罚决定：吊销大连金港安迪生物制品有限公司的《药品生产许可证》；注销该公司人用狂犬病疫苗的药品批准证明文件及其药品GMP证书；该公司直接责任人10年内不得从事药品生产经营活动。

JGAD概况

JGAD在中国国家工商局注册了“JGAD”的商标。电、水、煤气、通讯等基础设施符合疫苗生产的要求。JGAD占地55,000 m2 ，绿化面积占总面积的45%。为避免花粉污染产品和生产环境，厂区内禁止种植花卉。厂区环境、路面、运输都不产生污染。所有生产、行政、生活和辅助区域分别独立，布局合理。生产车间根据工艺流程和空气洁净度等级要求进行合理布局。JGAD拥有自己的污水处理站。处理后中水主要用于绿化和冷却水循环系统。其余水排到城市排水系统。厂房依据GMP的要求设计。JGAD各级组织机构中拥有足够数量的管理和技术人员，他们具有丰富的技术和经验，能够满足GMP的要求。

目前，JGAD有两个产品生产车间，各个车间内的清洁区分3级：100.000级区（相当于WHO的D级），10.000级区（相当于WHO的 C级）,100级区（相当于WHO的B级，但在无菌分装区域相当于WHO的A级）。根据不同的生产工艺的要求，每个级别的洁净区内分别有独立的操作间。洁净室的空气质量进行常规检测动态和静态条件下的尘埃粒子和微生物数。

JGAD的产品为非最终灭菌的产品，因此生产的每一步骤都应该是无菌的。空气净化系统、水系统、灭菌柜、灌装线、冻干机、房间的温度调节系统、过滤器等关键设备在使用前需要经过验证和定期的再验证。生产和QC的程序需要验证后实行。疫苗生产使用的原料和工具在使用前需要经过灭菌。细胞培养基和其他生产需要的物品使用前需经过湿热灭菌或除菌过滤。

JGAD的员工必须接受入职和定期的GMP培训、公司的政策、生产和QC操作技能培训，卫生学和安全方面培训。严格执行更衣和卫生程序以减少对产品产生污染的危险。

洁净室的清洁和消毒依据验证程序进行，环境监测程序检测其效果。根据环境监测的结果对洁净室进行熏蒸消毒以去除难以清洁位置的微生物的污染。

JGAD的文件包括标准管理规程(SMP)，标准操作规程 (SOP)，技术标准 (JSB)，验证程序 (YZ)以及各种工作记录、证、卡等。每一个产品都有详细的生产操作规程，关键步骤经过验证。

JGAD的主要人员，包括总经理、生产经理、质量控制经理、QA和质量授权人。他们都是全职工作。生产和质量控制部门相互独立。QP为JGAD产品质量最终负责，并直接向总经理汇报。

JGAD的使命：稳定而高效的管理团队，领先的技术、安全有效的产品，致力于改善人类的健康水平。

JGAD Overview

Dalian JGAD Bio-products Co. Ltd. is located in High-tech Park, DD Port, Dalian. The facilities of JGAD were built in 2003. The GMP certificate was issued by the Chinese Food and Drug Administration (SFDA) for the manufacture of the rabies vaccine (Vero cell) for human use (small-volume liquid form) in April, 2004 and the certificate for the manufacture of the freeze-dried form of the same vaccine in August, 2006. In 2005, JGAD built new facilities next to the rabies vaccine facility for live attenuated mumps vaccine and other bio-products and the GMP certificate was issued by SFDA for mumps vaccine production in December, 2006. Each time JGAD successfully passed the GMP audit by SFDA without major deviations. JGAD has registered the trade mark “JGAD” in the Chinese National Industrial and Commercial Bureau. The basic infrastructure, like electricity, water, propane gas supply and communication system etc., meets the requirements for vaccine manufactures. JGAD occupies 55,000 m2 with 45% green areas. It is forbidden to grow flowers inside the factory gardens, to avoid contamination of the products and the manufacture environment by pollens. There is no pollution from the factory ground, road surface and transportation. The overall arrangement of the manufacture, administration, living and subsidiary areas are reasonable and independent. Workshops are rationally distributed according to manufacture process flow and its requirements for the clean air classification. JGAD has its own sewage treatment station. The treated water is mainly used for the gardening, the scenery and the cooling recycling water system. The rest flows to the city drainage system. The facilities are designed based on GMP requirements. Each level of the JGAD organization consists of an adequate numbers of managing and technical staff with adequate skills and experiences, meeting GMP requirements.

At present there are two production units in JGAD. Clean areas in these units are divided into 3 grades: class 100.000 (equals to WHO standard grade D), class 10.000 (equals to WHO standard grade C), class 100 (equal to WHO standard grade B, but in aseptic filling areas it equals to WHO grade A). Each clean area has its individual independent operation rooms for various manufacture process needs. The air quality in the clean rooms is monitored routinely for particles and microbes at rest and in operation.

The products manufactured by JGAD are not terminally sterilized products, so each step of the manufacturing process should be aseptic. Critical equipment like air conditioning system, water system, autoclaves, filling lines, lyophilizers, thermostatic rooms and filters are initially validated prior to use and re-validated periodically. Manufacturing and QC procedures are carried out after validation. Materials and manufacturing tools used for vaccine manufactures are sterilized before use. Culture media used in cell cultures and other processes are sterilized by moisture heat or sterilized by filtration before use.

JGAD personnel receives initial and continuing training on GMP , JGAD general policies, technical training to qualify for respective production and QC activities, sanitation, personal hygiene and safety issues. Adequate gowning and sanitation procedures are followed to reduce the risk of contamination of the product.

Clean rooms are cleaned and disinfected following validated procedures and the effect is checked in the environmental monitoring program. Depending on the results of the environmental monitoring the clean rooms are fumigated to eliminate microbiological contamination in inaccessible places.

JGAD documents include Standard Management Procedures (SMP), Standard Operation Procedures (SOP), Quality Standards and Process Standards (JSB) and Validation procedures (YZ) as well as various work sheets, certificates, cards etc. Each product has its detailed manufacturing process procedures described in standard operation procedures and critical steps in the processes are validated.

Key personnel in JGAD include General

Manager, Production Manager, Quality Control manager,

QA manager and the Qualified Person. All are full-time

staff. Production department and quality control department

are independent from each other. The QP has final

responsibility for the quality of the JGAD products and

reports directly to the General Manager.

The mission of JGAD is “stable and efficient management team; leading research/development and technology; safe and effective products; improving human’s health level”.