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.

根據生產說明和SOP開展日常生產活動，包括生產、清潔和日常維護。
?所有操作必須符合相關責任區(qū)域的操作/設備操作程序。
?根據生產要求，對工藝進行持續(xù)監(jiān)控，以確保所有工藝參數都在控制范圍內。
?在該地區(qū)開展API材料配送和生產活動。
?監(jiān)控生產環(huán)境并填寫相關記錄。
?確保所有材料按照SOP的規(guī)范在適當的條件下儲存。
?根據要求及時填寫、檢查和簽署所有生產記錄。
?根據SOP正確填寫容器、設備和材料的狀態(tài)標簽。
?嚴格遵守安全、健康和環(huán)境。
?按照Cipla EHS規(guī)范和當地規(guī)范進行操作。

處理
根據廢物處理程序生產廢物，確保沒有對環(huán)境的污染。
?根據
驗證/資格協(xié)議的要求，執(zhí)行
驗證/鑒定活動。
?立即報告
車間異常情況向相關人員反映并填寫
及時做好相關記錄。
?接受培訓
由相關部門組織，包括崗位培訓、GMP、安全、，
衛(wèi)生、應用和生產原理。
批處理過程中的管線清理/
產品轉換。
?開展日常工作
在潔凈區(qū)制造，以確保符合Cipla質量規(guī)范和當地標準
規(guī)范。