大連金港安迪生物製品有限公司

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基本信息

• 中文名稱：大連金港安迪生物製品有限公司

2009年1月初，中國藥品生物製品檢定所在對狂犬疫苗監督檢驗中發現，遼寧大連金港安迪生物製品有限公司2008年生產的部分人用狂犬病疫苗中檢出違法添加的核酸物質，屬故意造假行為。其造假手段類似在奶粉中添加“三聚氰胺”，只是換成了名為“聚肌胞注射液”的添加物，添加後不僅在檢測時能提高抗原含量，還可以使企業的生產成本降低約一半。但是，這樣做的後果是，被狗咬傷的傷者注射疫苗後由於劑量不足，難以起到防疫的效果。事件原因在於企業“針對標準造假”，由於核酸不在疫苗的成分之列，正常的出廠檢驗不包含這項檢測，監管部門只有對其產品做核酸成分的補充檢查時，才能發現問題。藥品監管部門按照藥品管理有關法律法規的相關規定作出處罰決定：吊銷大連金港安迪生物製品有限公司的《藥品生產許可證》；註銷該公司人用狂犬病疫苗的藥品批准證明檔案及其藥品GMP證書；該公司直接責任人10年內不得從事藥品生產經營活動。
JGAD概況
JGAD在中國國家工商局註冊了“JGAD”的商標。電、水、煤氣、通訊等基礎設施符合疫苗生產的要求。JGAD占地55,000 m2 ，綠化面積占總面積的45%。為避免花粉污染產品和生產環境，廠區內禁止種植花卉。廠區環境、路面、運輸都不產生污染。所有生產、行政、生活和輔助區域分別獨立，布局合理。生產車間根據工藝流程和空氣潔淨度等級要求進行合理布局。JGAD擁有自己的污水處理站。處理後中水主要用於綠化和冷卻水循環系統。其餘水排到城市排水系統。廠房依據GMP的要求設計。JGAD各級組織機構中擁有足夠數量的管理和技術人員，他們具有豐富的技術和經驗，能夠滿足GMP的要求。
目前，JGAD有兩個產品生產車間，各個車間內的清潔區分3級：100.000級區（相當於WHO的D級），10.000級區（相當於WHO的 C級）,100級區（相當於WHO的B級，但在無菌分裝區域相當於WHO的A級）。根據不同的生產工藝的要求，每個級別的潔淨區內分別有獨立的操作間。潔淨室的空氣品質進行常規檢測動態和靜態條件下的塵埃粒子和微生物數。
JGAD的產品為非最終滅菌的產品，因此生產的每一步驟都應該是無菌的。空氣淨化系統、水系統、滅菌櫃、灌裝線、凍乾機、房間的溫度調節系統、過濾器等關鍵設備在使用前需要經過驗證和定期的再驗證。生產和QC的程式需要驗證後實行。疫苗生產使用的原料和工具在使用前需要經過滅菌。細胞培養基和其他生產需要的物品使用前需經過濕熱滅菌或除菌過濾。
JGAD的員工必須接受入職和定期的GMP培訓、公司的政策、生產和QC操作技能培訓，衛生學和安全方面培訓。嚴格執行更衣和衛生程式以減少對產品產生污染的危險。
潔淨室的清潔和消毒依據驗證程式進行，環境監測程式檢測其效果。根據環境監測的結果對潔淨室進行熏蒸消毒以去除難以清潔位置的微生物的污染。
JGAD的檔案包括標準管理規程(SMP)，標準操作規程 (SOP)，技術標準 (JSB)，驗證程式 (YZ)以及各種工作記錄、證、卡等。每一個產品都有詳細的生產操作規程，關鍵步驟經過驗證。
JGAD的主要人員，包括總經理、生產經理、質量控制經理、QA和質量授權人。他們都是全職工作。生產和質量控制部門相互獨立。QP為JGAD產品質量最終負責，並直接向總經理匯報。
JGAD的使命：穩定而高效的管理團隊，領先的技術、安全有效的產品，致力於改善人類的健康水平。
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”.