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rhett82

金虫 (小有名气)

菩提本无树,明镜亦非台,本来 ...

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虫号: 245946
注册: 2006-04-29
性别: GG
专业: 药学

[交流] CGMP的十项基本原则（中英文对照），觉得对您有用就顶一下！

TEN PRINCIPLES OF GOD MANUFACTURING PRACTICE
1.write procedures!
we shall write procedures to describe each operation-to enable each one of us to understand
how to carry out the operations consistently.
it could be a proceduer for testing material,manufacturing a batch,operating an equipment
2.follow the written proceduer!
we shall follow the procedures we have written-we have to "comply" with what is written
in the procedure and  should not "deviate"
3.document(record) the work!
we have to record our work. this is a proof of the operation we carried out-to ourselves and the
outsiders-the inspectors and customers
4.validate the work!
we need to prove that our work(operation) produces a consistent result-validation-
"a documented evidence that each procedure,process or method produces a result that
consistently meets the pre-determined criteria"
to put it simply,everytime we manufacture a product or operate an eqripment or test a material,
we have to get the same result.
5.design and build proper facilities and equipment!
our uesponsibility towards the quality starts from our facilities.
external features: location(area,climate),surroundings,quality of construction,infrastructure,
availability of human resources
internal features
adequate storgge areas for proper segregation of material
unidirectional flow of materials following the logical sequence of activities
adequate change uooms to facilitate appropriate entry &exit procedures of personnel
adequate ventilation air filtration and lighting
appropriate utility aystems such as water, steam, compressed air
adequate provisions for drainage and waste disposal
6.maintain the facilities and equipment!
after designing and constructing the facility and installing the equipment, we need to maintain them.
equipment should be designed suitably to perform the desired operations.
the equipment have to be installed and qualified for its operation and performance
the equipment should enable proper cleaning
7.be competent!
we can be competent(capable) as a result of: education-you already possess;training-you
are/will receive(ing); experience- you well achieve
8.be clean!
  we can be a source of contamination! it is very important for us to maintain our hygiene not only for
us to maintain our hygiene not only for our well being but also for the products we manufacture.
9.control for quality!
the quality of our products is of great importance as it has a direct bearing on the health of the patient.
we need to have strict quality control masures to ensure a quality product.
10.audit for compliance!
  enternal audit is an important tool to ensure implementation of GMP, compliance to the SOPs and  their

approved procedures.

CGMP 十项基本原则
1.明确各岗位人员的工作职责。
2.在厂房，设施和设备的设计，建造过程中，充分考虑生产能力，产品质量和员工的身心健康。
3.对厂房，设施和设备进行适当的维护，以保证始终处于良好的状态。
4.将清洁工作作为日常的习惯，防止产品污染。
5.开展验证工作，证明系统的有效性，正确性和可靠性。
6.起草详细的规程，为取得始终如一的结果提供准确的行为指导。
7.认真遵守批准的书面规程，防止污染，混淆和差错。
8.对操作或工作及时，准确地记录归档，以保证可追溯性，符合GMP要求。
9.通过控制与产品有关的各个阶段，将质量建立在产品生产过程中。
10.定期进行有计划的自检。

[ Last edited by rhett82 on 2006-5-16 at 16:15 ]

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