Tag: Stability testing

Determining Sample Quantity for Stability Testing Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for determining the number of samples required for performing stability tests to ensure adequate and representative sampling throughout the study duration. Scope This SOP applies to all stability studies conducted on drug substances and drug…

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Sample Labeling Procedure for Stability Testing Purpose The purpose of this Standard Operating Procedure (SOP) is to establish a standardized method for labeling stability study samples to ensure accurate identification, traceability, and compliance with regulatory requirements. Scope This SOP applies to all stability study samples of drug substances and drug products within the pharmaceutical company’s…

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Sample Storage Setup for Stability Testing Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the process for configuring the storage environment for stability study samples to ensure consistency, compliance, and integrity of the samples. Scope This SOP applies to all stability study samples of drug substances and drug products within the…

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Controlled Storage of Stability Study Samples Before Analysis Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for storing stability study samples under controlled conditions prior to analysis to ensure sample integrity and compliance with regulatory requirements. Scope This SOP applies to all stability study samples of drug substances and drug…

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Conducting Stress Tests on Bulk Drug Substances for Stability Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for conducting stress tests on bulk drug substances to assess their stability under various stress conditions, thereby identifying potential degradation products and establishing degradation pathways. Scope This SOP applies to all…

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Scheduling and Environmental Conditions for US Pivotal/Bioequivalence Stability Testing Purpose The purpose of this Standard Operating Procedure (SOP) is to define the intervals and climatic conditions for conducting pivotal or bioequivalence stability studies of drug substances and drug products intended for the US market. This ensures compliance with regulatory guidelines and generates reliable stability data…

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Scheduling and Environmental Conditions for US Stability Testing Purpose The purpose of this Standard Operating Procedure (SOP) is to establish the intervals and climatic conditions for conducting stability studies of drug substances and drug products intended for the US market. This ensures compliance with regulatory guidelines and generates reliable stability data. Scope This SOP applies…

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Scheduling and Environmental Conditions for US Validation/PM Stability Testing Purpose The purpose of this Standard Operating Procedure (SOP) is to establish the intervals and climatic conditions for conducting validation or post-marketing (PM) stability studies of drug substances and drug products intended for the US market. This ensures compliance with regulatory guidelines and generates reliable stability…

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Stability Testing of Reference Listed Drug (RLD) Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the process for placing the Reference Listed Drug (RLD) on stability testing. This is to ensure that the RLD is evaluated under specified conditions to generate stability data necessary for regulatory submissions and comparison with test…

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Packaging and Labeling of Stability Testing Samples Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for packaging stability samples. This ensures that the samples are protected from environmental factors and remain in a suitable condition for stability testing. Scope This SOP applies to all stability samples, including drug substances…

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