Pharma Stability: Insights, Guidelines, and Expertise
SOP for Determining the Impact of Temperature on Drug Stability Procedure for Evaluating the Effect of Temperature on Drug Stability 1) Purpose The purpose of this SOP is to provide a detailed procedure for determining the impact of temperature on the stability of drug substances and products. This evaluation helps in understanding the effects of…
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How to Address Stability Testing for Combination Antiretroviral Therapy (cART) under Regulatory Guidelines Stability Testing for Combination Antiretroviral Therapy: A Regulatory Guide Introduction Combination Antiretroviral Therapy (cART) is a critical treatment regimen for managing HIV/AIDS, involving the use of multiple antiretroviral drugs in a single formulation. Stability testing for cART is essential to ensure the…
How to Conduct Stability Testing for Biosimilars in Compliance with WHO Guidelines Stability Testing for Biosimilars: A WHO Compliance Guide Introduction Biosimilars, which are biological products highly similar to their reference biologics, require comprehensive stability testing to ensure their safety, efficacy, and quality. The World Health Organization (WHO) provides guidelines for stability testing of biosimilars,…
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How to Implement Stability Testing for Pediatric Formulations under US FDA and EMA Guidelines Stability Testing for Pediatric Formulations: A Regulatory Compliance Guide Introduction Pediatric formulations, which are specifically designed for children, require tailored stability testing to ensure their safety, efficacy, and quality. The US FDA and EMA have established guidelines that address the unique…
How to Conduct Stability Studies for Drug Products Stored at Subzero Temperatures under Regulatory Guidelines Stability Studies for Drug Products at Subzero Temperatures: A Regulatory Guide Introduction Drug products stored at subzero temperatures, such as biologics, vaccines, and certain advanced therapies, require specific stability studies to ensure their safety, efficacy, and quality throughout their shelf…
How to Implement Stability Testing for Polymorphic Drug Substances under Regulatory Guidelines Stability Testing for Polymorphic Drug Substances: Ensuring Regulatory Compliance Introduction Polymorphism in drug substances can significantly impact their stability, solubility, and bioavailability. Polymorphic forms of a drug may exhibit different physical and chemical properties, making stability testing essential to ensure the safety, efficacy,…
How to Address Stability Testing Requirements for Global Harmonization under ICH Guidelines Global Harmonization of Stability Testing: Navigating ICH Guidelines Introduction Global harmonization of stability testing is crucial for ensuring consistent quality, safety, and efficacy of pharmaceutical products across different markets. The International Council for Harmonisation (ICH) provides guidelines that unify stability testing requirements for…
SOP for Establishing Shelf Life Using Stability Data Procedure for Determining Shelf Life of Pharmaceuticals Using Stability Data 1) Purpose The purpose of this SOP is to provide guidelines for establishing the shelf life of pharmaceutical products using data obtained from stability studies. 2) Scope This SOP applies to all stability studies conducted to determine…
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How to Implement Stability Testing for Orally Inhaled and Nasal Drug Products (OINDP) under FDA Guidelines Ensuring Stability of Orally Inhaled and Nasal Drug Products: A Guide to FDA Compliance Introduction Orally Inhaled and Nasal Drug Products (OINDPs), including inhalers, nasal sprays, and nebulizers, are complex formulations that require rigorous stability testing to ensure their…
How to Conduct Stability Studies for Controlled Drugs under Regulatory Guidelines Ensuring Compliance in Stability Studies for Controlled Drugs Introduction Controlled drugs, including narcotics and psychotropics, require stringent stability testing to ensure their safety, efficacy, and quality throughout their shelf life. Regulatory authorities, such as the US DEA, FDA, and international bodies, provide specific guidelines…
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