-
GMP INSPECTION GUIDELINE FOR BIO-PRODUCT
生物制品
GMP
检查指南
< br>
GMP INSPECTION GUIDELINE FOR BIO-
PRODUCT
由国家食品药品监督管理局颁发
ISSUED BY SFDA OF CHINA
1.
机构与人员
COMPANY
ORGANIZATION AND PERSONNEL
?
0402
：
生物制品生产企业生产和质
量管理负责人是否具有相应的专业知识（细菌学、病
毒学、生物学、分子生物学、生物化
学、免疫学、医学、药学等），并具有丰富的实践
经验以确保在其生产、质量管理中履行
其职责。
Whether the personnel
who are in charge of the bio-products production
and quality
management that have the
corresponding knowledge background on
Bacteriology,
Virology, Biology,
Molecular Biology, Biochemistry, Immunology,
Medicine,
Pharmaceutics etc. and to
possess abundant experience to insure fulfilling
the
responsibilities in the production
and quality management.
?
0702
：从事生物制品制造的全体人员（包括清洁人员、维修人员
）是否根据其生产的制
品和所从事的生产操作进行专业（卫生学、微生物学等）和安全防
护培训。
Whether all the
personnel (including the cleaning stuff and
maintenance stuff) that
related with
the bio-products production who have received the
professional training on
production and
corresponding knowledge (Hygiene, Microbiology
etc.) and security
training.
2.
厂房与设施
PREMISE AND FACILITY
?
＊
220
1
：生产用菌毒种与非生产用菌毒种、生产用细胞与非生产用细胞、强毒与弱毒、
死毒与活毒、脱毒前与脱毒后的制品和活疫苗与灭活疫苗、人血液制品、预防制品等加
工或灌装是否同时在同一生产厂房内进行。
Whether the process or filling
procedure about the production or non-production
cell
bank or seed bank, strong or weak
strain, inactive or active strain, before or after
detoxicant, dead or living strain,
human blood product, preventive product etc. are
proceeding in the same facility at the
same time.
?
＊
2202
：生产用菌毒种与非生产用菌毒种
、生产用细胞与非生产用细胞、强毒与弱毒、
死毒与活毒、脱毒前与脱毒后的制品和活疫
苗与灭活疫苗、人血液制品、预防制品等贮
存是否严格分开。
Whether the storage about the
production or non-production cell bank or seed
bank,
strong or weak strain, inactive
or active strain, before or after detoxicant, dead
or living
strain, human blood product,
defendant product etc. are strictly separated.
?
＊
220
3
：不同种类的活疫苗的处理、灌装是否彼此分开。
Whether the process and filling for
various living vaccines are separated from each
others.
1
GMP INSPECTION GUIDELINE FOR BIO-
PRODUCT
?
＊
2204
：
强毒微生物操作区是否与相邻区域保持相
对负压，
是否有独立的空气净化系统，
排出的空气是否循环使用
。
Whether the pressure in
the operation area for the strong strain to be
kept relatively
negative comparing to
the abut areas. And is there independent air
system and is the
air re-circulated?
?
＊
220
5
：
芽孢菌制品操作区是否与相邻区域保持相对负压，
是否有独立的空气净化系统，
排出的空气是否循环使用，芽孢菌制品的操
作直至灭活过程完成之前是否使用专用设备。
Whether
the pressure in the operation area for the spore
bacteria preparation to be kept
relatively negative comparing to the
abut areas. And is there independent air system
and is the air re-circulated? Is there
specified equipment to be applied although the
duration of spore bacteria product
preparation until the inactivation procedure?
?
＊
2206
：各类生物制品生产中涉及高危致病因子的操作，其空气净
化系统等设施是否符
合特殊要求。
Whether the air system for various bio-
products related to high risk pathogenic factors
which are in compliance with the
special requirement.
?
＊
220
7
：生物制品生产过程中使用某些特定活生物体阶段的设备是否专用，是否在隔离
或封闭系统内进行。
Whether
the equipment to be used in special phase of
production for some living
organisms in
the manufacture of bio-product which is separated
and been applied in the
isolated
environment.
?
<
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＊
2208
：卡介苗生产厂房和结核菌素
生产厂房是否与其它制品生产厂房严格分开，卡介
苗生产设备要专用。
< br>
Whether the premise for the BCG
vaccine or tuberculin production which is strictly
separated with others premise. And the
equipment for BCG vaccine production must be
specified.
?
＊
220
9
：炭疽杆菌、肉毒梭状芽孢杆菌和破伤风梭状芽孢杆菌制品在相应专用设施内生
产。
Whether the ci,
Clostridium Botulinum and Clostridium tetanus
preparation
those are manufactured with
specified equipment.
?
＊
221
0
：设备专用于生产孢子形成体，当加工处理一种制品时是否集中生产，某一设施
或一套设施中分期轮换生产芽孢菌制品时，在规定时间内是否只生产一种制品。
The equipment must be specified in
the production of sporeformer. Is the production
centralized when processing one
preparation? When manufacturing different
varieties
of spore products with one
set of equipment in turn, is that only one product
to be
prepared in the established
period.
?
＊
2211
：生物制品生产的厂房与设施是否对原材
料、中间体和成品存在潜在污染。
Whether the
premise and facility which to be applied to
manufacture the bio-products
that will
pollute the raw material, intermediate product and
final product potentially.
?
＊
221
2
：聚合酶链反应试剂（
PCR
）的生
产和检定是否在各自独立的建筑物中进行，防
止扩增时形成的气溶胶造成交叉污染。
Whether the production and
inspection of PCR reagents to be proceeded in the
isolated
2
GMP
INSPECTION GUIDELINE FOR BIO-PRODUCT
area to prevent the cross-contamination
caused by aerosol in the amplification
procedure.
?
＊
221
3
：生产人免疫缺陷病毒（
HIV
）等
检测试剂，在使用阳性样品时，是否有符合相应
规定的防护措施和设施。
When manufacturing the HIV
relevant test reagents, is there any equipment or
facility in
compliance with the
established provision during the process of
manipulating the
positive sample.
?
＊
2214
：生产用种子批和细胞库，是否在规定储存条件下专库存放
，是否只允许指定的
人员进入。
Whether only authorized personnel are
permitted to enter the area where storing the
seed lot and cell bank and whether all
these materials are stored in the specified
warehouse pursuant to the specified
condition.
?
＊
2215
：以人血、人血浆或动物脏器、组
织为原料生产的制品是否使用专用设备，是否
与其他生物制品的生产严格分开。
Is there specified equipment to
be applied to the production which based on the
raw
material of human blood, human
plasma or animal tissue? Is this kind of
production to
be isolated strictly with
others bio-product preparation?
?
＊
221
6
：使用密闭系统生物发酵罐生产生物制品可以在同一区域同时生产（如单克隆抗
体和重组
DNA
制品）。
The bio-product manufactures which
manipulated with the air-locked bioreactor that
can be preceded in the same area at
same time (e.g. monoclonal antibody &
recombinant DNA preparation).
?
＊
2217
：各种灭活疫苗（包括重组
DNA
产品）、类毒素及细胞提取物，在其灭活或消毒
后可以与其他无
菌制品交替使用同一灌装间和灌装、冻干设施。但在一种制品分装后，
必须进行有效的清
洁和消毒，清洁消毒效果是否定期验证。
All kinds
of inactive vaccines (including recombinant DNA
products), toxoid and cell
extract
which can be filling and lyophilized in the same
equipment alternately with
others
sterile products after inactivation or
disinfecting process. But after the distribution
of one product, the equipment must be
effectively cleaned and disinfected right away
and verify the effectiveness of
cleaning and disinfecting periodically.
?
＊
2218
：操作有致病作用的微生物是否在专门的区域内进行，是否
保持相对负压。
Whether the process
of pathogenic microorganism is applied in the
specified area and
whether it kept
relatively negative pressure in this area.
?
＊
221
9
：有菌（毒）操作区与无菌（毒）操作区是否有各自独立的空气净化系统，来自
病原体操作区的空气是否循环使用。
Are
there independent air decontamination systems
between toxic and non-toxic
working
areas and is the air in the pathogen process area
re-circulated?
?
＊
2220
：来自危险度为二类以上病原体的空气是否通过除菌
过滤器排放，滤器的性能是
否定期检查。使用二类以上的病原体强污染性材料进行制品生
产时，对其排出污物是否
有有效的消毒设施。
Whether the air from the rooms of
pathogen hazard class 2 or above which is filtered
3