Carry out daily production activities according to production
instructions and SOPs, including production, cleaning and daily maintenance.

• All operations must
comply with the operation/equipment operating procedures in the relevant area
of responsibility.

• According to
production requirements, the process is constantly monitored to ensure that all
process parameters are within the control range.

• Carry out Dispensing
of API material and Manufacturing activities in area.

• Monitoring and
Control of Production environment and filling the related records.

• To ensure that all
materials are stored under the appropriate conditions as per specification
according to SOPs.

• To fill, check and
sign all production records without delay according to requirement.

• To fill out the
Status labelling of containers, equipments and materials correctly according to
SOPs.

• Strict adherence to
safety, health & environment.

• Carry out operations
as Cipla EHS codes and local norms.

• Dispose the
production waste according to the waste disposal procedure to ensure no
pollution to the environment.

• According to the
requirements of the verification/qualification protocol, carry out the
verification/qualification activities.

• Immediately report
the abnormal situation in the workshop to relevant personnel and fill in
relevant records in a timely manner.

• Receive training
organized by the related department, including job training, GMP, safety,
hygiene, application and production principles. Line clearance during batch /
product change over.

• Carry out the daily
mfg. in clean area to ensure compliance with Cipla quality codes and local
norms.

根据生产说明和SOP开展日常生产活动，包括生产、清洁和日常维护。
•所有操作必须符合相关责任区域的操作/设备操作程序。
•根据生产要求，对工艺进行持续监控，以确保所有工艺参数都在控制范围内。
•在该地区开展API材料配送和生产活动。
•监控生产环境并填写相关记录。
•确保所有材料按照SOP的规范在适当的条件下储存。
•根据要求及时填写、检查和签署所有生产记录。
•根据SOP正确填写容器、设备和材料的状态标签。
•严格遵守安全、健康和环境。
•按照Cipla EHS规范和当地规范进行操作。

处理
根据废物处理程序生产废物，确保没有对环境的污染。
•根据
验证/资格协议的要求，执行
验证/鉴定活动。
•立即报告
车间异常情况向相关人员反映并填写
及时做好相关记录。
•接受培训
由相关部门组织，包括岗位培训、GMP、安全、，
卫生、应用和生产原理。
批处理过程中的管线清理/
产品转换。
•开展日常工作
在洁净区制造，以确保符合Cipla质量规范和当地标准
规范。