SOP For Laboratory Incident

OBJECTIVE: The purpose of this SOP is to lay down the procedure for reporting, initiation, review, approval, compliance and closing of Laboratory incident.     SCOPE: This SOP is applicable for reporting, initiation, review, approval, compliance and closing of Laboratory incident Which occurs in Quality Control laboratory at the manufacturing facility.      RESPONSIBILITY: Quality …

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SOP For Recording Temperature and Humidity of Stability Chamber

OBJECTIVE: The purpose of this SOP is to lay down a procedure for recording temperature and humidity of stability chamber. SCOPE:  This SOP is applicable Stability chambers in Quality Control Department at manufacturing facility. RESPONSIBILITY: Analyst / Section Head or his designee shall be responsible for follow the SOP. The Head of Quality Control Department …

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SOP For Storage and Handling of Raw Material Control Sample

OBJECTIVE: The objective of this Standard Operating Procedure (SOP) is to lay down a procedure for handling, storage and destruction of control samples of Raw material. SCOPE:  This SOP is applicable to Control samples of all raw material in Quality Control Department at manufacturing facility. RESPONSIBILITY: Analyst / Section Head or his designee shall be …

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SOP For Operating, Calibration , Maintaining and Cleaning of FTIR Spectrophotometer

OBJECTIVE: The purpose of this SOP is to lay down a procedure for operating, calibration, maintaining and cleaning of the FTIR Spectrophotometer. SCOPE:  This SOP is applicable to FTIR spectrophotometer (Make: Bruker, Model: Alpha – E) at Quality Control Department at manufacturing facility.    RESPONSIBILITY: Analyst or his designee shall be responsible for follow the …

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SOP For Rounding Digits

OBJECTIVE: The purpose of this SOP is to lay down a procedure for rounding to significant figures without affecting the safety, identity, strength, purity and quality of the Product. SCOPE:  This SOP is applicable to Quality Control Department at manufacturing facility.    RESPONSIBILITY: Analyst or his designee shall be responsible for follow the SOP. The …

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SOP For Operation and Calibration of Total Organic Carbon (TOC)

OBJECTIVE:  The purpose of this SOP is to lay down a procedure for Handling, Operation, Maintenance and Calibration of Total Organic Carbon (TOC) analyser in Quality Control Department. SCOPE: This SOP is applicable to TOC analyser in Quality Control Department at manufacturing facility.     RESPONSIBILITY:   Officer/ Executive shall be responsible for the effective …

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SOP For Sending Sample For Analysis To External Laboratory

OBJECTIVE: The purpose of this SOP is to lay down a procedure for sending sample for analysis to external laboratory. SCOPE:  This SOP is applicable to Quality Control Department at manufacturing facility.     RESPONSIBILITY: Analyst or his designee shall be responsible for follow the SOP. The Head of Quality Control Department or his designee …

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SOP For Receiving of current updates on Pharmacopoeias

OBJECTIVE: The purpose of this SOP is for Receiving of current updates on Pharmacopoeias in Quality Control Department. SCOPE:  This SOP is applicable to Quality Control Department at manufacturing facility .    RESPONSIBILITY: Authorized designee of Quality Control department shall be responsible for Receiving / reviewing of current updates on Pharmacopoeias. The Head of Quality …

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SOP For Operation and Calibration of the Cold Chamber

  OBJECTIVE:  The purpose of this Standard Operating Procedure (SOP) is to describe the operation and Calibration of the Cold Chamber.   SCOPE: This SOP is applicable to Quality Control Department at manufacturing facility.       RESPONSIBILITY:     Officer/ Executive shall be responsible for the effective handling, operation, maintenance, calibration and validation of …

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