最新的GMP审核验厂检查表完整版
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2
0
0
Are there adequate environmental controls for the building?If the product under assessment requires environmental controls, ensure that the supplier has controlled and verified temperature at critical areas. If environmental control is inadequate, the answer is NO. If environmental control is not applicable to the production, the answer is N/A.
虫害控制程序是否合适？确保有外发的定期虫害控制合约，合约至少包括a)服务内容和所有材料b)鼠笼的安放位置图c)虫害防治公司的营业执照，检查12个月的虫害控制记录，鼠笼等设备有编号，可以追溯。鼠笼等设备合适安装并定期检查证据
3
0
0
Are the washrooms and toilets clean and in good working order?Clean, stocked with Antibacterial Soap and single use napkin/towel, running hot water.
工厂是否干净（评估的整个过程都要观察工厂清洁情况，工厂应该有定义清洁的环境要素并持续改善清洁状况）
2
0
0
Are there written procedures addressing the maintenance of the facility?Preventive Maintenance policies and schedules should be documented. Records should be available for review and should contain information regarding daily pre-operation equipment inspection, daily monitoring of equipment function, daily housekeeping activities, sanitation activities and any other necessary activities to maintain the safety and quality of product.有没有书面的厂房/设施维护程序？预防性维护的政策和程序。每日开机检查记录，每日设备功能检查记录，每日打扫卫生记录，以及其他所需的工作来保证产品的安全和质量……
建筑物是否有合适的环境控制，如果产品有环境控制需求，请确保供应商有控制和确认温度。
3
0
0
Is the lighting adequate for the building?
建筑内部照明是否充足
1
0
0
Is the pest control program adequate?Ensure that a contract exists that documents a regularly scheduled pest control service program. The contract package should include at a minimum: a) written documentation regarding the service performed and type of materials used; b) a current map indicating the locations of all rodent traps; c) copies of the licenses and certificates of insurance for the pest control company and current license for inspectors. Review a representative sample of inspection records from the last 12 months. Ensure that any pest problems noted have been addressed and had been addressed prior to the next inspection. Ensure the traps/devices are traceable either by numerical labeling, bar coding or other method. Ensure that the pest control inspector has initialed or provided some other documentation to support that all traps had been properlyinspected. Finally, to receive a YES for this question, no sign of rodent activity was noted during the course of this assessment.
存储化学品的设施是否合适/充足？确保所有化学品都按照其MSDS要求合适存储，避免污染。否则答案为“NO”
3
0
0
Is the facility in satisfactory structural condition?NoRodent Entry Points, No broken Glass or Windows, Ceiling does not indicate water damage or structural defects.
是否有清洁用化学品清单。这些用来清洁的化学品应该有合适的批准程序批准，有MSDS数据。如果发现任何没有在清单中的化学品，或则没有MSDS，答案就应该是“No”
1
0
0
Is storage of chemicals used in the facility adequate?Ensure that all chemicals are stored in a manner consistent with the instructions per their MSDS sheets. Additionally, ensure that the method ofstorage is in such a manner to eliminate product contamination. Answer is NOif storage conflicts with either requirement above.
肥料处理是否合适，垃圾桶附近干净整洁。
1
0ห้องสมุดไป่ตู้
0
Is the design of the facility adequate to allow for smooth flow of materials and reduce potential for contamination?
工厂平面结构设计是否合理，可以是物料流转顺畅，避免潜在的污染风险
组织架构图？最新，有批准和受控
2
0
0
Is quality assurance independent of manufacturing?Ensure that the ToO describes separation of manufacturing authority and quality assurance authority.
FE1
Is the facility clean (internal/external)?Throughout the course of the assessment, observation of cleanliness should be taken. Cleanliness should be defined as an environment that reduces and/or eliminates the potential for contamination.
备件仓是否组织良好？备件仓需同生产隔离。关键零件必须要备件并有清单控制
1
0
0
TOTAL SCORE FOR THIS SECTION
25
0
0
Is a Table of Organization (ToO) available for review?Current? Approved? Controlled? Must be able to say YES to these subsequent requirements in order to score YES.
厂房结构是否令人满意，没有虫害入侵点，没有破碎的玻璃或窗户。天花板没有漏水的痕迹。
3
0
0
Is waste material handled appropriately?Ensure the dumpster areas are clean and well organized. External waste is not excessive.
水房和厕所是否良好？干净，有防菌肥皂和一次性纸巾，热水
3
0
0
Is an organized spare parts inventory kept on hand at the factory?Look for a room or area separate from production that contains spare parts for the production equipment. Does not need to be all spare parts, but at a minimum should be critical parts needed to keep the equipment running. Factory should have inventory list.
有没有独立于生产的品质保证部门。组织架构同应该有体现
2
0
0
Are up to date biographies (CVs) available for supervisory personnel shown on the ToO?
主管以上人员必须要简历保存
1
0
0
Does the quality department have adequate coverage during all shifts?Review last 30 days of shift schedules. For every production shift, there must be documented QC coverage to score a YES. *Guidance:“Documented QC Coverage”may be demonstrated through a combination of both of the following practices: 1) Designation of“Quality Responsible”operator(s) during a 2nd or 3rd shift. This is acceptable so long as verification of training may be provided and conclusion drawn that designated“Quality Responsible”operators have the education, experience and knowledge to act in the role of QC. 2) The vendor must have procedure and records to ensure that QA reviews and releases all batches prior to shipment.品质部门是否有足够的人员去覆盖所有的生产班次?检查最近30天的生产安排，每个生产班，都必须有品质文件，“品质文件”是指：1）每班有指定合格的品质负责人，且品质负责人有合适的培训，经验和知识2)供应商必须有程序和记录确保出货前qa检查每批货物。
2
0
0
Is there a list of approved chemicals for maintaining the sanitation of the facility?Chemicals used for any of the above activities should be defined within the approved procedures and policies. Material Safety Data Sheets should be maintained for all chemicals. An appropriate sample of chemicals should be selected and MSDS requested for each. If any chemicals are observed in use without approval or if any of the chemicals selected do not have MSDS provided, the answer is NO.
0
0
Are there adequate environmental controls for the building?If the product under assessment requires environmental controls, ensure that the supplier has controlled and verified temperature at critical areas. If environmental control is inadequate, the answer is NO. If environmental control is not applicable to the production, the answer is N/A.
虫害控制程序是否合适？确保有外发的定期虫害控制合约，合约至少包括a)服务内容和所有材料b)鼠笼的安放位置图c)虫害防治公司的营业执照，检查12个月的虫害控制记录，鼠笼等设备有编号，可以追溯。鼠笼等设备合适安装并定期检查证据
3
0
0
Are the washrooms and toilets clean and in good working order?Clean, stocked with Antibacterial Soap and single use napkin/towel, running hot water.
工厂是否干净（评估的整个过程都要观察工厂清洁情况，工厂应该有定义清洁的环境要素并持续改善清洁状况）
2
0
0
Are there written procedures addressing the maintenance of the facility?Preventive Maintenance policies and schedules should be documented. Records should be available for review and should contain information regarding daily pre-operation equipment inspection, daily monitoring of equipment function, daily housekeeping activities, sanitation activities and any other necessary activities to maintain the safety and quality of product.有没有书面的厂房/设施维护程序？预防性维护的政策和程序。每日开机检查记录，每日设备功能检查记录，每日打扫卫生记录，以及其他所需的工作来保证产品的安全和质量……
建筑物是否有合适的环境控制，如果产品有环境控制需求，请确保供应商有控制和确认温度。
3
0
0
Is the lighting adequate for the building?
建筑内部照明是否充足
1
0
0
Is the pest control program adequate?Ensure that a contract exists that documents a regularly scheduled pest control service program. The contract package should include at a minimum: a) written documentation regarding the service performed and type of materials used; b) a current map indicating the locations of all rodent traps; c) copies of the licenses and certificates of insurance for the pest control company and current license for inspectors. Review a representative sample of inspection records from the last 12 months. Ensure that any pest problems noted have been addressed and had been addressed prior to the next inspection. Ensure the traps/devices are traceable either by numerical labeling, bar coding or other method. Ensure that the pest control inspector has initialed or provided some other documentation to support that all traps had been properlyinspected. Finally, to receive a YES for this question, no sign of rodent activity was noted during the course of this assessment.
存储化学品的设施是否合适/充足？确保所有化学品都按照其MSDS要求合适存储，避免污染。否则答案为“NO”
3
0
0
Is the facility in satisfactory structural condition?NoRodent Entry Points, No broken Glass or Windows, Ceiling does not indicate water damage or structural defects.
是否有清洁用化学品清单。这些用来清洁的化学品应该有合适的批准程序批准，有MSDS数据。如果发现任何没有在清单中的化学品，或则没有MSDS，答案就应该是“No”
1
0
0
Is storage of chemicals used in the facility adequate?Ensure that all chemicals are stored in a manner consistent with the instructions per their MSDS sheets. Additionally, ensure that the method ofstorage is in such a manner to eliminate product contamination. Answer is NOif storage conflicts with either requirement above.
肥料处理是否合适，垃圾桶附近干净整洁。
1
0ห้องสมุดไป่ตู้
0
Is the design of the facility adequate to allow for smooth flow of materials and reduce potential for contamination?
工厂平面结构设计是否合理，可以是物料流转顺畅，避免潜在的污染风险
组织架构图？最新，有批准和受控
2
0
0
Is quality assurance independent of manufacturing?Ensure that the ToO describes separation of manufacturing authority and quality assurance authority.
FE1
Is the facility clean (internal/external)?Throughout the course of the assessment, observation of cleanliness should be taken. Cleanliness should be defined as an environment that reduces and/or eliminates the potential for contamination.
备件仓是否组织良好？备件仓需同生产隔离。关键零件必须要备件并有清单控制
1
0
0
TOTAL SCORE FOR THIS SECTION
25
0
0
Is a Table of Organization (ToO) available for review?Current? Approved? Controlled? Must be able to say YES to these subsequent requirements in order to score YES.
厂房结构是否令人满意，没有虫害入侵点，没有破碎的玻璃或窗户。天花板没有漏水的痕迹。
3
0
0
Is waste material handled appropriately?Ensure the dumpster areas are clean and well organized. External waste is not excessive.
水房和厕所是否良好？干净，有防菌肥皂和一次性纸巾，热水
3
0
0
Is an organized spare parts inventory kept on hand at the factory?Look for a room or area separate from production that contains spare parts for the production equipment. Does not need to be all spare parts, but at a minimum should be critical parts needed to keep the equipment running. Factory should have inventory list.
有没有独立于生产的品质保证部门。组织架构同应该有体现
2
0
0
Are up to date biographies (CVs) available for supervisory personnel shown on the ToO?
主管以上人员必须要简历保存
1
0
0
Does the quality department have adequate coverage during all shifts?Review last 30 days of shift schedules. For every production shift, there must be documented QC coverage to score a YES. *Guidance:“Documented QC Coverage”may be demonstrated through a combination of both of the following practices: 1) Designation of“Quality Responsible”operator(s) during a 2nd or 3rd shift. This is acceptable so long as verification of training may be provided and conclusion drawn that designated“Quality Responsible”operators have the education, experience and knowledge to act in the role of QC. 2) The vendor must have procedure and records to ensure that QA reviews and releases all batches prior to shipment.品质部门是否有足够的人员去覆盖所有的生产班次?检查最近30天的生产安排，每个生产班，都必须有品质文件，“品质文件”是指：1）每班有指定合格的品质负责人，且品质负责人有合适的培训，经验和知识2)供应商必须有程序和记录确保出货前qa检查每批货物。
2
0
0
Is there a list of approved chemicals for maintaining the sanitation of the facility?Chemicals used for any of the above activities should be defined within the approved procedures and policies. Material Safety Data Sheets should be maintained for all chemicals. An appropriate sample of chemicals should be selected and MSDS requested for each. If any chemicals are observed in use without approval or if any of the chemicals selected do not have MSDS provided, the answer is NO.