Author: digi

SOP for Determining Degradation Pathways in Stability Studies

SOP for Determining Degradation Pathways in Stability Studies Procedure for Identifying Degradation Pathways in Stability Studies 1) Purpose The purpose of this SOP is to provide a standardized procedure for identifying degradation pathways of drug products through stability studies. Understanding these pathways helps in determining the causes of degradation and developing strategies to enhance product…

Stability Studies SOP

How to Conduct Stability Studies for Complex Parenteral Products in Compliance with Regulatory Guidelines

How to Conduct Stability Studies for Complex Parenteral Products in Compliance with Regulatory Guidelines Stability Testing for Complex Parenteral Products: A Regulatory Guide Introduction Complex parenteral products, such as injectable emulsions, suspensions, and liposomes, require rigorous stability testing to ensure their safety, efficacy, and quality throughout their shelf life. These products present unique challenges due…

'How to' - Stability Studies

How to Implement Stability Testing for Solid Dispersions in Compliance with Regulatory Guidelines

How to Implement Stability Testing for Solid Dispersions in Compliance with Regulatory Guidelines Stability Testing for Solid Dispersions: A Regulatory Compliance Guide Introduction Solid dispersions, which improve the solubility and bioavailability of poorly water-soluble drugs, require specific stability testing to ensure their safety, efficacy, and quality. These formulations present unique challenges due to the potential…

'How to' - Stability Studies

Analytical Data Record for Conducting Stability Studies for Temperature-Sensitive Biologics

Analytical Data Record for Conducting Stability Studies for Temperature-Sensitive Biologics Comprehensive Analytical Data Record for Temperature-Sensitive Biologic Stability Studies This template captures data from stability studies for biologic products that are highly sensitive to temperature variations, tracking activity retention, potency, and degradation. Parameter Details Product Name [Biologic Product Name] Batch Number [Batch Number] Test Parameters…

Stability Documentation

How to Conduct Stability Studies for Combination Vaccines under WHO and FDA Guidelines

How to Conduct Stability Studies for Combination Vaccines under WHO and FDA Guidelines Stability Testing for Combination Vaccines: A Guide to WHO and FDA Compliance Introduction Combination vaccines, which protect against multiple diseases with a single injection, require rigorous stability testing to ensure their safety, efficacy, and quality. Regulatory authorities, including the WHO and FDA,…

'How to' - Stability Studies

Analytical Data Record for Performing Stability Studies for Sterile Products

Analytical Data Record for Performing Stability Studies for Sterile Products Comprehensive Analytical Data Record for Sterile Product Stability Studies This template records stability data for sterile pharmaceutical products, focusing on sterility, degradation, and physical integrity under various storage conditions. Parameter Details Product Name [Sterile Product Name] Batch Number [Batch Number] Test Parameters – Sterility –…

Stability Documentation

SOP for Conducting Stability Studies for Biologics

SOP for Conducting Stability Studies for Biologics Procedure for Performing Stability Studies for Biologic Drug Products 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability studies on biologic drug products to evaluate their shelf life and storage conditions under various environmental factors such as temperature, humidity, and light….

Stability Studies SOP

How to Implement Stability Testing for Nanomedicines under Regulatory Guidelines

How to Implement Stability Testing for Nanomedicines under Regulatory Guidelines Stability Testing for Nanomedicines: Navigating Regulatory Requirements Introduction Nanomedicines, which utilize nanoscale materials to deliver therapeutic agents, pose unique challenges in stability testing due to their complex structures, surface properties, and interactions with biological systems. Regulatory authorities, including the US FDA, EMA, and WHO, have…

'How to' - Stability Studies

Analytical Data Record for Assessing Stability for Enzyme-Based Drugs

Analytical Data Record for Assessing Stability for Enzyme-Based Drugs Comprehensive Analytical Data Record for Enzyme-Based Drug Stability Studies This template captures stability data for enzyme-based drugs, focusing on activity retention, degradation products, and temperature sensitivity under different storage conditions. Parameter Details Product Name [Enzyme-Based Drug Name] Batch Number [Batch Number] Test Parameters – Enzyme Activity…

Stability Documentation

How to Conduct Stability Studies for Drug Products in Extreme Conditions per Regulatory Guidelines

How to Conduct Stability Studies for Drug Products in Extreme Conditions per Regulatory Guidelines Stability Testing for Drug Products in Extreme Conditions: Ensuring Regulatory Compliance Introduction Drug products intended for use in extreme conditions, such as high altitude, extreme temperatures, or high humidity, require specialized stability testing to ensure their safety, efficacy, and quality. Regulatory…

'How to' - Stability Studies