Author: digi

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

How to Apply ICH Q6A for Specification Setting in Stability Testing

How to Apply ICH Q6A for Specification Setting in Stability Testing Applying ICH Q6A for Specification Setting in Stability Studies Introduction ICH Q6A, “Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products,” provides guidelines for setting specifications that define the quality of a drug substance or product. Applying ICH Q6A…

'How to' - Stability Studies

Analytical Data Record for Conducting Stability Studies for Drug Implants

Analytical Data Record for Conducting Stability Studies for Drug Implants Comprehensive Analytical Data Record for Drug Implant Stability Studies This document records data from stability studies for drug implants, evaluating mechanical integrity, drug release, and sterility under various storage conditions. Parameter Details Product Name [Drug Implant Name] Batch Number [Batch Number] Test Parameters – Mechanical…

Stability Documentation

SOP for Interpreting Stability Data for Regulatory Submissions

SOP for Interpreting Stability Data for Regulatory Submissions Guidelines for Interpreting Stability Data for Regulatory Submissions 1) Purpose The purpose of this SOP is to provide a standardized procedure for interpreting stability data to ensure it meets the requirements for regulatory submissions. The aim is to determine if the stability data supports the proposed shelf…

Stability Studies SOP

How to Conduct Stability Testing for Liposomal Drug Products under Regulatory Guidelines

How to Conduct Stability Testing for Liposomal Drug Products under Regulatory Guidelines Stability Testing for Liposomal Drug Products: A Regulatory Compliance Guide Introduction Liposomal drug products, which utilize lipid-based carriers to deliver active ingredients, require specific stability testing to ensure their safety, efficacy, and quality throughout their shelf life. These formulations present unique challenges due…

'How to' - Stability Studies