Pharma Stability: Insights, Guidelines, and Expertise
SOP for Evaluating the Impact of Oxygen on Drug Stability Procedure for Assessing the Impact of Oxygen on Drug Stability 1) Purpose The purpose of this SOP is to provide a standardized procedure for evaluating the impact of oxygen on the stability of drug products to determine appropriate packaging and storage conditions to prevent oxidation….
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How to Prepare Stability Testing Reports for US FDA Inspections Preparing Stability Testing Reports for US FDA Inspections Introduction Stability testing reports are crucial documents that must be prepared accurately to demonstrate compliance with regulatory standards during US FDA inspections. These reports provide comprehensive data on the stability of drug products, ensuring that they maintain…
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SOP for Conducting Stability Studies for Topical Products Procedure for Stability Studies on Topical Drug Products 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability studies on topical drug products to evaluate their shelf life, consistency, and storage conditions under various environmental factors such as temperature, humidity, and…
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How to Design Stability Studies for Drug Products with Extended Shelf Life under Regulatory Guidelines Stability Testing for Drug Products with Extended Shelf Life: Compliance with Regulatory Guidelines Introduction Drug products with an extended shelf life require robust stability testing to demonstrate that they maintain their quality, safety, and efficacy over longer periods. Regulatory authorities,…
How to Conduct Stability Testing for Advanced Therapy Medicinal Products (ATMPs) per EMA Guidelines Stability Testing for Advanced Therapy Medicinal Products: Compliance with EMA Guidelines Introduction Advanced Therapy Medicinal Products (ATMPs), including gene therapies, cell therapies, and tissue-engineered products, require rigorous stability testing to ensure they maintain their quality, safety, and efficacy throughout their shelf…
How to Implement Stability Testing for Drugs with Novel Delivery Systems under US FDA Guidelines Stability Testing for Drugs with Novel Delivery Systems: Compliance with FDA Guidelines Introduction Drugs with novel delivery systems, such as transdermal patches, nanoparticles, or implantable devices, require specialized stability testing to ensure their quality, safety, and efficacy throughout their shelf…
SOP for Performing Stability Studies for Ophthalmic Products Procedure for Conducting Stability Studies on Ophthalmic Drug Products 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability studies on ophthalmic drug products to evaluate their shelf life, sterility, and storage conditions under various environmental factors such as temperature, humidity,…
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How to Conduct Stability Studies for Drug Products in Compliance with Indian Regulatory Requirements (CDSCO) Stability Testing for Drug Products: Meeting CDSCO Guidelines in India Introduction Drug products marketed in India require stability testing to demonstrate that they maintain their quality, safety, and efficacy throughout their shelf life. The Central Drugs Standard Control Organization (CDSCO),…
How to Apply ICH Guidelines to Stability Testing for Radiopharmaceuticals Stability Testing for Radiopharmaceuticals: Compliance with ICH Guidelines Introduction Radiopharmaceuticals, which are radioactive compounds used for diagnosis or therapy, require specific stability testing to ensure they maintain their safety, efficacy, and quality throughout their shelf life. The International Council for Harmonisation (ICH) provides guidelines that…
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How to Implement Stability Testing for Cell Therapy Products under ICH Q5A Stability Testing for Cell Therapy Products: Compliance with ICH Q5A Guidelines Introduction Cell therapy products, which involve the use of living cells for therapeutic purposes, require specific stability testing to ensure they maintain their quality, safety, and efficacy throughout their shelf life. The…
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