附录3:
Annex 3:
生物制品
BIOLOGICAL MEDICINAL
第一章 范围
Chapter 1. Scope
第一条 生物制品的制备方法是控制产品质量的关键因素。采用下列制备方法的生物制品属本附录适用的范围:
Article 1 The methods employed in the manufacture of biological medicinal products are a critical factor in shaping the appropriate quality control. Biological medicinal products prepared by the following methods of manufacture will fall
under the scope of this annex:
(一)微生物和细胞培养,包括DNA 重组或杂交瘤技术;
(二)生物组织提取;
(三)通过胚胎或动物体内的活生物体繁殖。
a) Microbial and cell cultures, including those resulting from recombinant DNA or hybridoma techniques;
b) Extraction from biological tissues
c) Propagation of live agents in embryos or animals作者: uaubc 时间: 2014-8-9 14:05
Article 2: Biological medicinal products in this annex include: bacterial vaccines
(including anatoxin), viral vaccines, antitoxins, antiserums, blood products,
cytokines, growth factors, enzymes and in vitro or in vitro diagnostic reagents
and other active biological agents, e.g., toxins, antigens, allergens, monoclonal
antibodies, antigen-antibody complexes, immunoregulators and
microbioecologics, etc.作者: uaubc 时间: 2014-8-9 14:06
第三条 生物制品的生产和质量控制应当符合本附录要求和国家相关规定。
Article 3: The production and quality control of biological medicinal products
should meet the requirements of the annex and related State regulations.作者: uaubc 时间: 2014-8-9 14:07
第二章 原则 Chapter 2 Principle
第四条 生物制品具有以下特殊性,应当对生物制品的生产过程和中间产品的检验进行特殊控制:
Article 4: The production of biological medicinal products and the test for
intermediates should involve certain specific controls arising from the following
nature of the products and the processes:
(一)生物制品的生产涉及生物过程和生物材料,如细胞培养、活生物体材料提取等。这些生产过程存在固有的可变性,因而其副产物的范围和特性也存在可变性,甚至培养过程中所用的物料也是污染微生物生长的良好培养基。
1. The production of biological medicinal products involves biological
processes and materials, such as cultivation of cells or extraction of material
from living organisms. These biological processes may display inherent
variability, so that the range and nature of by-products are variable. Moreover,
the materials used in these cultivation processes provide good substrates for
growth of microbial contaminants.
(二)生物制品质量控制所使用的生物学分析技术通常比理化测定具有更大的可变性。
2. Biological analytical techniques involved in the quality control of biological
medicinal products usually have a greater variability than physico-chemical
determinations.
(三)为提高产品效价(免疫原性)或维持生物活性,常需在成品中加入佐剂或保护剂,致使部分检验项目不能在制成成品后进行。
3. Some analytical tests cannot be carried out on the finished product due to
often added adjuvant and protective agents in the finished products to enhance
the potency (immunogenicity) or to maintain biological activity.作者: uaubc 时间: 2014-8-9 14:07
第五条 从事生物制品生产、质量保证、质量控制及其他相关人员(包括清洁、维修人员)均应根据其生产的制品和所从事的生产操作进行专业知识和安全防护要求的培训。
Article 5: All personnel involved in manufacture of biological products, quality
assurance, quality control and other related personnel (including those
concerned with cleaning and maintenance) should receive additional technical
and safety protection training specific to the products manufactured and to their
work.
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理解
1-培训要包括安全,尤其是生物安全的培训。
2-所有可能接触产品或者关键区域的人员,都应该接受相关培训。作者: uaubc 时间: 2014-8-9 14:08
第六条 生产管理负责人、质量管理负责人和质量受权人应当具有相应的专业知识(微生物学、生物学、免疫学、生物化学、生物制品学等),并能够在生产、质量管理中履行职责。
Article 6: Persons who are responsible for production and quality management
as well as Authorized Person should have an adequate background in relevant
scientific disciplines, such as microbiology, biology, immunology, biochemistry,
biological products, together with sufficient practical experience to enable them
to exercise their functions for the production and quality management
concerned.作者: uaubc 时间: 2014-8-9 14:08
第七条 应当对所生产品种的生物安全进行评估,根据评估结果,对生产、维修、检验、动物饲养的操作人员、管理人员接种相应的疫苗,并定期体检。
Article 7: All personnel engaged in production, maintenance, testing and animal care (and managers) should be vaccinated with appropriate specific
vaccines and have regular health checks based on the biological safety
evaluation for products.作者: uaubc 时间: 2014-8-9 14:09
相关疾病:
传染病皮肤病
第八条 患有传染病、皮肤病以及皮肤有伤口者、对产品质量和安全性有潜在不利影响的人员,均不得进入生产区进行操作或质量检验。未经批准的人员不得进入生产操作区。
Article 8: Personnel affected by an infectious disease, dermatosis, or having
open lesions on the exposed surface of the body, and could potentially affect the
quality and safety of the products should be excluded from production areas and
not allowed to engage in the production operations or quality inspections.
Unauthorized person should be excluded from production areas.作者: uaubc 时间: 2014-8-9 14:09
第九条 从事卡介苗或结核菌素生产的人员应当定期进行肺部X 光透视或其它相关项目健康状况检查。
Article 9: Production of BCG vaccine and tuberculin products should be
restricted to staff who are carefully monitored by regular checks of
immunological status or chest X-ray.作者: uaubc 时间: 2014-8-9 14:09
第十条 生产期间,未采用规定的去污染措施,员工不得从接触活有机体或动物体的区域穿越到生产其它产品或处理不同有机体的区域中去。
Article 10: During the manufacturing period, personnel should not pass from
areas where exposure to live organisms or animals to areas where other
products or organisms are handled unless they complied with clearly defined
decontamination measures作者: uaubc 时间: 2014-8-9 14:10
第十一条 从事生产操作的人员应当与动物饲养人员分开,不得兼任。
Article 11: Production personnel should not engage in animal care.作者: uaubc 时间: 2014-8-9 14:30
第十二条 生物制品生产环境的空气洁净度级别应当与产品和生产操作相适应,厂房与设施不应对原料、中间体和成品造成污染。
Article 12: Air cleanliness classification for production environment of biological medicinal products should be adapted to the requirements of product and
operation. The premises and facilities for production should not result in any
potential contamination risk to starting materials, intermediates and final
products.作者: uaubc 时间: 2014-8-9 14:30
十四条 生物制品的生产操作应当在符合下表中规定的相应级别的洁净区内进行,未列出的操作可参照下表在适当级别的洁净区内进行:
Article 14: Production operations for biological medicinal products should be
carried out in the corresponding classification of clean areas according to the
table as below. Those operations which are not listed out may consult this table
for appropriate classification of clean area:
第十五条 在生产过程中使用某些特定活生物体的阶段,应当根据产品特性和设备情况,采取相应的预防交叉污染措施,如使用专用厂房和设备、阶段性生产方式、使用密闭系统等。
Article 15: During those stages of the manufacturing process in which live
organisms are used, it may require relevant precautions to prevent the risk of
cross-contamination with respect to facilities and equipment, such as the use of
dedicated facilities and equipment, production on a campaign basis and the use
of closed systems.作者: uaubc 时间: 2014-8-9 14:40
第十六条 灭活疫苗(包括基因重组疫苗)、类毒素和细菌提取物等产品灭活后,可交替使用同一灌装间和灌装、冻干设施。每次分装后,应当采取充分的去污染措施,必要时应当进行灭菌和清洗。
Article 16: Inactive vaccines (including recombinant vaccine), toxoids, extracts of
bacterial species etc. can share the same filling room, and filling, freeze-drying
facilities on a campaign basis. However, the effective decontamination
procedures, such as cleaning and sterilization when necessary, should be
applied after each filling.作者: uaubc 时间: 2014-8-9 14:40
第十七条 卡介苗和结核菌素生产厂房必须与其它制品生产厂房严格分开,生产中涉及活生物的生产设备应当专用。
Article 17: Premises used for the production of BCG vaccine and tuberculin
products should be strictly separated with others. Dedicated facilities should be
separately used for live organisms.作者: uaubc 时间: 2014-8-9 14:41
第十五条 在生产过程中使用某些特定活生物体的阶段,应当根据产品特性和设备情况,采取相应的预防交叉污染措施,如使用专用厂房和设备、阶段性生产方式、使用密闭系统等。
Article 15: During those stages of the manufacturing process in which live
organisms are used, it may require relevant precautions to prevent the risk of
cross-contamination with respect to facilities and equipment, such as the use of
dedicated facilities and equipment, production on a campaign basis and the use
of closed systems.
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