Tag: Stability Protocols for New Drugs

SOP for Performing Stability Studies for Ophthalmic Products

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,…

Stability Studies SOP

How to Conduct Stability Studies for Drug Products in Compliance with Indian Regulatory Requirements (CDSCO)

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' - Stability Studies

How to Apply ICH Guidelines to Stability Testing for Radiopharmaceuticals

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…

'How to' - Stability Studies

How to Implement Stability Testing for Cell Therapy Products under ICH Q5A

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…

'How to' - Stability Studies

SOP for Conducting Stability Studies for Controlled-Release Formulations

SOP for Conducting Stability Studies for Controlled-Release Formulations Procedure for Stability Studies of Controlled-Release Formulations 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability studies on controlled-release formulations to evaluate their shelf life, drug release profile, and storage conditions under various environmental factors such as temperature, humidity, and…

Stability Studies SOP

How to Conduct Stability Testing for Gene Therapy Products as per FDA Guidelines

How to Conduct Stability Testing for Gene Therapy Products as per FDA Guidelines Stability Testing for Gene Therapy Products: Compliance with FDA Guidelines Introduction Gene therapy products, which involve the transfer of genetic material into cells to treat or prevent diseases, require rigorous stability testing to ensure they maintain their quality, safety, and efficacy throughout…

'How to' - Stability Studies

How to Perform Stability Studies for Vaccines in Compliance with WHO Guidelines

How to Perform Stability Studies for Vaccines in Compliance with WHO Guidelines Stability Testing for Vaccines: Compliance with WHO Guidelines Introduction Vaccines, which are crucial for preventing infectious diseases, require stringent stability testing to ensure they remain safe and effective throughout their shelf life. The World Health Organization (WHO) provides specific guidelines for conducting stability…

'How to' - Stability Studies

How to Conduct Stability Studies for Injectable Products per ICH Guidelines

Stability Testing for Injectable Products: Applying ICH Guidelines Introduction Injectable products, such as solutions, emulsions, and suspensions for injection, require rigorous stability testing to ensure their safety, efficacy, and quality throughout their shelf life. The International Council for Harmonisation (ICH) provides specific guidelines, including ICH Q1A(R2) and ICH Q1E, for conducting stability studies for…

'How to' - Stability Studies

SOP for Developing Stability Protocols for Global Markets

SOP for Developing Stability Protocols for Global Markets Procedure for Creating Stability Protocols for Global Regulatory Markets 1) Purpose The purpose of this SOP is to provide a standardized procedure for developing stability study protocols that comply with the regulatory requirements of multiple global markets to ensure successful product registration and commercialization. 2) Scope This…

Stability Studies SOP

How to Implement Stability Testing for Veterinary Drugs as per US FDA and EMA Guidelines

How to Implement Stability Testing for Veterinary Drugs as per US FDA and EMA Guidelines Stability Testing for Veterinary Drugs: Compliance with FDA and EMA Guidelines Introduction Veterinary drugs, like human pharmaceuticals, require stability testing to ensure they maintain their quality, safety, and efficacy throughout their shelf life. The US FDA and the EMA provide…

'How to' - Stability Studies