Stability Studies SOP

The purpose of this SOP is to define a procedure for conducting stability testing for orally inhaled and nasal drug products (OINDP) in accordance with US FDA guidelines. This ensures that these products maintain their quality, safety, and efficacy throughout their shelf life.
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The purpose of this SOP is to define a procedure for conducting stability testing to meet global harmonization requirements as outlined by the International Council for Harmonisation (ICH) guidelines. This ensures that drug products comply with the stability testing standards of multiple regulatory authorities.
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The purpose of this SOP is to define a procedure for conducting stability testing for polymorphic drug substances in compliance with relevant regulatory guidelines. This ensures that polymorphic substances maintain their intended form, quality, safety, and efficacy throughout their shelf life.
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The purpose of this SOP is to establish a procedure for conducting stability studies for drug products stored at subzero temperatures in compliance with relevant regulatory guidelines. This ensures that these products maintain their quality, safety, and efficacy throughout their shelf life under subzero storage conditions.
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The purpose of this SOP is to define the procedures for conducting stability testing for pediatric formulations in compliance with US FDA and EMA guidelines. This ensures that pediatric formulations maintain their quality, safety, and efficacy throughout their shelf life.
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The purpose of this SOP is to establish a procedure for conducting stability testing for biosimilar products in compliance with the World Health Organization (WHO) guidelines. This ensures that biosimilars maintain their quality, safety, and efficacy throughout their shelf life.
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The purpose of this SOP is to establish a procedure for conducting stability testing for combination antiretroviral therapy (cART) in compliance with relevant regulatory guidelines. This ensures that cART products maintain their safety, efficacy, and quality throughout their shelf life.
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The purpose of this SOP is to define a procedure for conducting stability studies for drug products in multi-layered packaging in compliance with relevant regulatory guidelines. This ensures that these products maintain their intended quality, safety, and efficacy throughout their shelf life.
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The purpose of this SOP is to establish a procedure for conducting stability studies for dermatological products in compliance with relevant regulatory guidelines. This ensures that these products maintain their quality, safety, and efficacy throughout their shelf life.
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The purpose of this SOP is to define a procedure for preparing stability data in compliance with the US FDA’s Quality by Design (QbD) approach. This ensures that stability data supports product quality throughout its lifecycle by systematically understanding and controlling variability.
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