Pharma Stability: Insights, Guidelines, and Expertise
Preparing a Schedule for Withdrawal of Stability Samples Completing Storage Period Purpose The purpose of this SOP is to outline the procedure for preparing a schedule for the withdrawal of stability samples that have completed their designated storage period. Scope This SOP applies to all stability studies conducted within the pharmaceutical company where samples are…
Determining Batch Quantity and Size for Stability Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the process for determining the number and size of batches required for stability testing to ensure representativeness, consistency, and regulatory compliance. Scope This SOP applies to all stability studies conducted on drug substances and drug…
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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…
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…
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…
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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