Stability Studies SOP

The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for preparing a stability protocol for drug substances and drug products in compliance with the ICH Q1A(R2) guidelines. This SOP ensures that the stability protocol is comprehensive, clear, and in line with regulatory requirements.
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The purpose of this SOP is to provide a standardized procedure for conducting stability studies in compliance with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) guidelines to ensure the safety, quality, and efficacy of drug products.
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The purpose of this SOP is to provide a standardized approach for managing stability testing following post-approval changes to drug substances and products in compliance with US FDA guidelines.
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The purpose of this SOP is to provide a standardized procedure for conducting stability testing of new dosage forms in compliance with ICH Q1C guidelines to ensure their quality, safety, and efficacy over their intended shelf life.
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The purpose of this SOP is to provide a standardized procedure for developing stability study reports for Abbreviated New Drug Applications (ANDAs) to the US FDA, ensuring compliance with regulatory requirements.
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The purpose of this SOP is to provide a standardized procedure for documenting stability studies in support of New Drug Applications (NDAs) to the US FDA to ensure compliance with regulatory requirements.
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The purpose of this SOP is to provide a standardized approach for conducting stability studies for modified-release products in compliance with US FDA and ICH guidelines to ensure their safety, quality, and efficacy throughout their shelf life.
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The purpose of this SOP is to establish a procedure for designing stability studies for combination products, such as drug-device combinations, in compliance with applicable regulatory guidelines to ensure their safety, efficacy, and quality over their shelf life.
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The purpose of this SOP is to provide a standardized procedure for evaluating stability data in compliance with ICH Q1E guidelines to ensure the quality, safety, and efficacy of drug substances and products throughout their shelf life.
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The purpose of this SOP is to outline the procedure for conducting stability studies for drug substances in compliance with US FDA guidelines to ensure their quality, safety, and efficacy throughout the intended shelf life.
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