Pharma Stability: Insights, Guidelines, and Expertise
The purpose of this SOP is to provide a standardized procedure for developing a stability-indicating analytical method that complies with ICH Q2(R1) guidelines to ensure the accuracy, precision, and reliability of stability testing.
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The purpose of this SOP is to establish a procedure for addressing stability issues in Abbreviated New Drug Applications (ANDA) submissions to the US FDA to ensure compliance with regulatory requirements.
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The purpose of this SOP is to provide a standardized procedure for conducting stability studies on biologic drug products in compliance with US FDA guidelines, ensuring the product’s safety, potency, and efficacy throughout its shelf life.
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The purpose of this SOP is to provide a standardized approach for conducting stability studies for drug products in compliance with US FDA CFR Title 21, ensuring that they meet the required quality standards over their shelf life.
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The purpose of this SOP is to provide a standardized procedure for preparing a stability protocol in compliance with the ICH Q1A(R2) guidelines to ensure the quality, safety, and efficacy of drug substances and products over their shelf life.
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The purpose of this SOP is to establish a standardized approach for conducting stability testing for drug products in compliance with the ASEAN (Association of Southeast Asian Nations) guidelines to ensure their quality, safety, and efficacy.
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The purpose of this SOP is to outline a procedure for conducting stability studies in compliance with the European Medicines Agency (EMA) guidelines to ensure that drug substances and products maintain their safety, quality, and efficacy.
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The purpose of this SOP is to provide a standardized procedure for reporting stability data in the Common Technical Document (CTD) format for regulatory submissions to health authorities.
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The purpose of this SOP is to outline the procedure for conducting bracketing and matrixing in stability studies in compliance with ICH Q1D guidelines, optimizing the testing of multiple strengths and packaging configurations.
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The purpose of this SOP is to establish a standardized procedure for conducting stability testing of drug products to ensure compliance with US FDA stability testing requirements, thereby confirming the quality, safety, and efficacy of the products throughout their shelf life.
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