Tag: Humidity Effects on Drugs

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

How to Apply Stability Testing Guidelines for New Drug Submissions to EMA

How to Apply Stability Testing Guidelines for New Drug Submissions to EMA Stability Testing for New Drug Submissions: Compliance with EMA Guidelines Introduction New drug submissions to the European Medicines Agency (EMA) require comprehensive stability testing to demonstrate that the drug product will maintain its quality, safety, and efficacy over its shelf life. The EMA…

'How to' - Stability Studies

How to Conduct Stability Testing for Sterile Products as per Regulatory Requirements

How to Conduct Stability Testing for Sterile Products as per Regulatory Requirements Stability Testing for Sterile Products: Compliance with Regulatory Standards Introduction Sterile products, including injectables, ophthalmic solutions, and other aseptically processed products, require stringent stability testing to ensure they remain sterile, safe, and effective throughout their shelf life. Regulatory authorities such as the US…

'How to' - Stability Studies

SOP for Evaluating the Impact of Light Exposure on Drug Products

SOP for Evaluating the Impact of Light Exposure on Drug Products Procedure for Assessing the Impact of Light Exposure on Drug Products 1) Purpose The purpose of this SOP is to provide a standardized procedure for evaluating the impact of light exposure on the stability of drug products. This assessment helps in determining suitable packaging…

Stability Studies SOP

How to Address Stability Testing Requirements for Herbal Medicines per Regulatory Guidelines

How to Address Stability Testing Requirements for Herbal Medicines per Regulatory Guidelines Stability Testing for Herbal Medicines: Meeting Regulatory Standards Introduction Herbal medicines, derived from plant materials, require specific stability testing to ensure their quality, safety, and efficacy over their shelf life. Regulatory authorities, such as the US FDA, EMA, and WHO, provide guidelines for…

'How to' - Stability Studies

How to Conduct Stability Testing as per ICH Q5C for Biotechnological/Biological Products

How to Conduct Stability Testing as per ICH Q5C for Biotechnological/Biological Products Implementing ICH Q5C Guidelines for Stability Testing of Biological Products Introduction Biotechnological and biological products, such as monoclonal antibodies, therapeutic proteins, and vaccines, require specific stability testing to ensure they maintain their quality, safety, and efficacy throughout their shelf life. The ICH Q5C…

'How to' - Stability Studies

How to Conduct Stability Testing for Biotech Products in Compliance with US FDA Guidelines

How to Conduct Stability Testing for Biotech Products in Compliance with US FDA Guidelines Stability Testing for Biotechnological Products: FDA Compliance Introduction Biotechnological products, such as monoclonal antibodies, recombinant proteins, and gene therapy products, require rigorous stability testing to ensure their quality, safety, and efficacy throughout their shelf life. The US FDA provides specific guidelines…

'How to' - Stability Studies

How to Implement Stability Testing for Temperature-Sensitive Products per ICH Q1A(R2)

How to Implement Stability Testing for Temperature-Sensitive Products per ICH Q1A(R2) Stability Testing for Temperature-Sensitive Products: Applying ICH Q1A(R2) Guidelines Introduction Temperature-sensitive products, such as biological drugs, vaccines, and certain chemical compounds, require specialized stability testing to ensure they maintain their quality, safety, and efficacy throughout their shelf life. The ICH Q1A(R2) guidelines provide specific…

'How to' - Stability Studies

How to Address Stability Testing Requirements for Pediatric Drug Products per Regulatory Guidelines

How to Address Stability Testing Requirements for Pediatric Drug Products per Regulatory Guidelines Stability Testing for Pediatric Drug Products: Meeting Regulatory Requirements Introduction Pediatric drug products require specific stability testing to ensure they remain safe and effective for use in children throughout their shelf life. Regulatory authorities such as the US FDA, EMA, and Health…

'How to' - Stability Studies