Stability Studies SOP

This SOP outlines the procedures for implementing risk management principles based on the ICH Q9 guidelines for stability testing. The goal is to identify, assess, and control risks that may impact the stability testing of drug products, ensuring consistent quality and regulatory compliance.
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The purpose of this SOP is to establish a standardized procedure for conducting stability studies on topical drug products in compliance with the regulatory guidelines of the US FDA and EMA. This ensures that topical products maintain their quality, efficacy, and safety throughout their intended shelf life.
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The purpose of this SOP is to define the procedures for conducting stability studies required for Investigational New Drug (IND) applications. This SOP ensures that stability data is generated in compliance with regulatory guidelines to support the safety and efficacy of the drug product during clinical trials.
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The purpose of this SOP is to define the procedures for conducting stability testing on drug-device combination products in accordance with the International Council for Harmonisation (ICH) Q1A(R2) guidelines. This ensures that such products maintain their intended quality, safety, and efficacy throughout their shelf life.
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The purpose of this SOP is to establish the procedure for conducting stability studies in compliance with the guidelines of the Brazilian Health Regulatory Agency (ANVISA). This ensures that drug products marketed in Brazil 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 testing on large molecule drugs (biologics) in accordance with US FDA guidelines. This ensures that such drugs maintain their quality, safety, and efficacy throughout their shelf life.
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The purpose of this SOP is to provide a structured approach for conducting stability testing of temperature-sensitive biologics in compliance with global regulatory guidelines. This ensures that biologics remain stable and effective under the required storage conditions.
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The purpose of this SOP is to establish a procedure for conducting stability testing of drugs intended for special populations (e.g., pediatric, geriatric, pregnant women) in compliance with relevant regulatory guidelines. This ensures that the drug product maintains its safety, efficacy, and quality for the intended population throughout its shelf life.
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The purpose of this SOP is to establish a standardized procedure for conducting stability studies for oncology drugs in compliance with the regulatory guidelines of the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This ensures the drugs maintain their intended quality, safety, and efficacy throughout their shelf life.
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The purpose of this SOP is to establish a standardized procedure for conducting stability testing on ophthalmic drug 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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