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| Address : |
1262 West Yanan Road ,Shanghai |
| Tel : |
62803189 |
| Zip : |
200052 |
| Fax : |
62801807 |
| Email: |
sibp@siobp.com |
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| Quality Assurance |
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| Manufacturing Institution |
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Manufacturing Department is a functional institution responsible for the management of the manufacturing in the whole institute under the leadership of the director.
1. Main Responsibilities:
Plan Management: Based on the requirement of the market, on the principle of balance between production and marketing, making efforts to make, adjust and carry out the annual, quarterly, and monthly production plans.
Scheduling Management: Based on the production of every office, coordinating the relationships among all the manufacturing offices, the relationships between manufacturing offices and other departments, and assure to carry out the production plan.
Technical Management: Based on the quality problems during the production and the requirement of the market, making plans about the improvement of the quality of the products with Quality Assurance Department and R&D Department, and inspecting the progressing of the technical breakthrough and technical improvement programs.
Security Management: Under the leadership of the Security Council, urging all the manufacturing offices to do the security work.
Equipment Management: Coordinating the manufacturing offices to do the repairing, maintaining, alternation, and renewing of the production equipments.
Environmental Management: Urging the manufacturing offices to carry out the national laws and regulations on environment protection.
2. Subordinate Manufacturing Offices:
First Vaccine Production Department
Second Vaccine Production Department
Center for Biotechnology
Blood Product Production Workshop
Filling and Package and Medium Department
Laboratory Animal Center
Shengsuo Reagent Departmen
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| GMP Workshops GMP |
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SIBP possesses highly clean premises, facilities and management system that meet the requirements of GMP.
Blood products are produced by advanced technique of press filtration in the closed pipes. Construction of the building of vaccine production with advanced facilities in which influenza split vaccine and lyophilized live attenuated varicella vaccine are produced by advanced international production techniques was aided by World Bank loan. The workshops of vaccine production, lyophilized powder for injection and filling designed and rebuilt on its own has obtained Certificate of GMP issued by State Food and Drug Administration. In the workshops, high quality products including BCG vaccine for intradermal injection, group A meningococcal polysaccharide vaccine, live attenuated measles, mumps and rubella combined vaccine, live attenuated rubella vaccine, live attenuated measles vaccine, Vi polysaccharide typhoid vaccine, recombinant human interferon-α1b, recombinant human interferon-γ, diphtheria, tetanus and pertussis combined vaccine are produced. The production of these products complies with the Chinese Pharmacopoeia, and on each batch of products, control tests are carried out as required by the authorities concerned. Some products at present are exported to foreign countries.
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| Quality Assurance System |
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Quality Assurance Department is responsible for quality control and inspection of the whole production process. The Department is staffed with personnel of professional quality control and inspection, as well as equipped with sufficient premises, instrument and facility adequate to the requirements of product, specification and quality control. Under the department, there are QA Office and Quality Control Office.
QA Office is responsible for implement of rules and regulations issued by state, and quality control of the whole production process, distribution of find products, establishment of document management system, and preparation, revision and review of manufacturing and quality control documents. It is responsible for monitoring cleanliness, water used in production, sterilization and filling system periodically, application for GMP validation, carrying out GMP self-inspection, and sampling and testing as required by the higher authorities. It is also responsible for feedback of product quality, evaluation of product stability, and reporting the quality situation in production at regular intervals to the director and higher authorities. Complete quality control system is the guarantee of the safety, effectiveness and high quality of products.
Quality control office is responsible for quality control of starting materials, bulk, final bulk and final product, establishment of new items of control test, and three-tier management of bacterial seed, virus seed and continuous cell. It is also responsible for purchase, preservation and distribution of standards, standard solutions and dangerous substances, and preparation of management documents regarding equipment, instruments reagents, standards, and titration solutions used in quality control.
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| Information About Quality Assurance |
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Reliable products, higher quality standard
Blood Product Production Workshop
Blood Product Production Workshop is a department of blood product production. The main products are human albumin, human immunoglobulin for intravenous injection, human immunoglobulin, human hepatitis B immunoglobulin, freeze-dried human fibrinogen, freeze-dried human prothrombin complex and human histaglobulin. The workshop obtained Certificate of GMP for Human Drugs in Sep.9th, 1999.
First Vaccine Production Department
First Vaccine Production Department is specialized in bacterial vaccine production. The products are the BCG, tetanus, whole-cell pertussis, acellular pertussis, tracheitis, furunculosis, diphtheria, epidemic encephalitis, typhoid, corynebacterium parvum, leptospira, and Schick Text Toxin. The bacterial vaccine workshop obtained Certificate of GMP for Human Drugs in Dec.24th, 2003.
Second Vaccine Production Department
Second Vaccine Production Department is responsible for viral vaccine production. The main products are live attenuated measles vaccine, live attenuated mumps vaccine, live attenuated measles and mumps combined vaccine, live attenuated rubella vaccine and inactivated Japanese encephalitis vaccine. The viral vaccine workshop obtained Certificate of GMP for Human Drugs in Mar.17th, 2003.
Center for Biotechnology
Center for Biotechnology is the national key project aided by World Bank loan. It is responsible for the production of recombinant human interferon-α1b for injection, recombinant human interferon-γfor injection, freeze-dried live attenuated varicella vaccine, split influenza virus vaccine, and live attenuated Japanese encephalitis vaccine. All the workshops have obtained Certificate of GMP for Human Drugs before March of 2003.
Filling and Package Workshop
Filling and Package Workshop includes lyophilized powder for injection workshop and small volume injections workshop, the main function of which are filling and packaging of the vaccine products. Filling and Package Workshop obtained Certificate of GMP for Human Drugs in Mar.17th, 2003. |
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