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Purpose : To describe the general procedure for usage of the equipment and cleaning. Scope : This procedure is applicable for equipment used for manufacturing at Arch Pharmalabs Ltd Tarapur

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Definitions : None Responsibilities : Production-Chemist Production-Executive Production-Manager Manager QA Activities / Procedure : Precautions : None All the equipment must be cleaned as per the respective Standard Operating Procedures/Equipment cleaning records, if possible immediately after use. If the equipment is clean, then the status shall be mentioned as CLEANED on the status board. If the equipment is not clean, then the status shall be mention as "TO BE CLEANED on the status board. Equipment shall be cleaned as early as possible. The status board contains following details: STATUS BOARD EQUIPMENT NO PRODUCT NAME STAGE BATCH NO BATCH SIZE STATUS DATE :::::::SIGN :KGS

: To update the status board and cleaning record of equipment. : To ensure and monitor the updation of records. : To implement the system and facility. : To ensure the effective system are in use.

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6.0

If any equipment is not used within 24 hours of cleaning then it must be cleaned again as per the Standard Operating Procedure before using it for manufacturing. Cleaning and Usage record shall be maintained as per (PRD/SOP/009/F1/0). Cleaning and usage log shall be maintained separately for each piece of equipment. Record the usage of the equipment used for a particular product on a campaign basis in Format No. (PRD/SOP/009/F1/0). Flow Chart : None Abbreviation : None

7.0

Annexure /Reference Documents / Records/ Formats :

Reference Documents : 7.1 Cleaning and Usage record (PRD/SOP/009/F1/0). Annexure : None 8.0 00 Revision History: Reason for Revision New Document

Rev No Effective Date