Tag: Long-term stability testing

Documentation of Climatic Conditions for Stability Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish the process for accurately recording and documenting the climatic conditions (temperature, humidity, etc.) during stability studies. This ensures that the environmental conditions are consistently monitored and reported, maintaining the integrity of the stability data. Scope This…

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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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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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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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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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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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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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Lux Meter Usage Procedure Purpose The purpose of this Standard Operating Procedure (SOP) is to establish the procedures for the proper operation of a lux meter. This ensures accurate measurement of light intensity in photostability chambers and other laboratory environments. Scope This SOP applies to all personnel using lux meters for measuring light intensity within…

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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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UV Meter Usage Procedure Purpose The purpose of this Standard Operating Procedure (SOP) is to establish the procedures for the proper operation of a UV meter. This ensures accurate measurement of ultraviolet light intensity in photostability studies and other laboratory environments. Scope This SOP applies to all personnel using UV meters for measuring ultraviolet light…

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