Tag: Pharmaceutical stability testing,

SOP for Review of Temperature and Humidity Recording Charts

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Monitoring and Management of Temperature and Humidity Records Purpose The purpose of this Standard Operating Procedure (SOP) is to establish the process for reviewing and controlling temperature and humidity recording charts used in stability studies. This ensures that environmental conditions are consistently monitored, recorded accurately, and deviations are promptly addressed to maintain the integrity of…

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Stability Studies SOP

SOP for Revalidation of Climatic Rooms and Chambers

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Revalidation Procedure for Stability Chambers Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the process for the periodic revalidation of climatic rooms and chambers used in stability studies. This ensures that these environments consistently meet specified conditions and maintain the integrity of the stability data. Scope This SOP applies to all…

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Stability Studies SOP

SOP for Sanitation and Housekeeping of Climatic Chambers

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Cleaning and Maintenance of Stability Chambers Purpose The purpose of this Standard Operating Procedure (SOP) is to establish the sanitation and housekeeping requirements for climatic chambers used in stability studies. This ensures that the chambers are maintained in a clean and orderly condition, preventing contamination and ensuring accurate stability data. Scope This SOP applies to…

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Stability Studies SOP

SOP for Conducting Photostability Study

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Photostability Testing Procedure Purpose The purpose of this Standard Operating Procedure (SOP) is to establish the procedures for conducting photostability studies on drug substances and drug products. This ensures that the products are tested under controlled light conditions to determine their stability when exposed to light. Scope This SOP applies to all drug substances and…

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Stability Studies SOP

SOP for Operation of Photostability Chamber

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Photostability Chamber operation Procedure Purpose The purpose of this Standard Operating Procedure (SOP) is to establish the procedures for the proper operation of photostability chambers used in stability studies. This ensures that the chambers are used correctly to provide accurate and reliable photostability data. Scope This SOP applies to all personnel operating photostability chambers for…

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Stability Studies SOP

SOP for Calibration of Photostability Chamber

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Photostability Chamber Calibration Procedure Purpose The purpose of this Standard Operating Procedure (SOP) is to establish the procedures for the calibration of photostability chambers. Proper calibration ensures that the chambers provide accurate and reliable light intensity and environmental conditions for stability studies. Scope This SOP applies to all photostability chambers used for stability studies within…

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Stability Studies SOP

SOP for Calibration of Lux Meter

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Lux Meter Calibration Procedure Purpose The purpose of this Standard Operating Procedure (SOP) is to establish the procedures for the calibration of lux meters used in photostability studies and other light intensity measurements. Proper calibration ensures accurate and reliable readings. Scope This SOP applies to all lux meters used for measuring light intensity within the…

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Stability Studies SOP