Tag: Stability study protocol

Analytical Data Record for Conducting Stability Studies for Intrathecal Drugs

Analytical Data Record for Conducting Stability Studies for Intrathecal Drugs Comprehensive Analytical Data Record for Intrathecal Drug Stability Studies This template is used to record the stability data of drugs administered intrathecally, with a focus on sterility, potency, and chemical stability under stringent storage conditions. Parameter Details Product Name [Intrathecal Drug Name] Batch Number [Batch…

Stability Documentation

How to Implement ICH Q8 for Stability Testing in Pharmaceutical Development

How to Implement ICH Q8 for Stability Testing in Pharmaceutical Development Applying ICH Q8 for Stability Testing in Pharmaceutical Development Introduction The ICH Q8 guideline, “Pharmaceutical Development,” emphasizes a systematic approach to development that ensures product quality through design, understanding, and control of manufacturing processes. Implementing ICH Q8 principles in stability testing helps to optimize…

'How to' - Stability Studies

Analytical Data Record for Evaluating Stability for Drugs in Multi-Dose Containers

Analytical Data Record for Evaluating Stability for Drugs in Multi-Dose Containers Comprehensive Analytical Data Record for Multi-Dose Container Drug Stability Studies This template records the data from stability studies for drugs stored in multi-dose containers, focusing on potency, contamination, and chemical degradation during repeated dosing. Parameter Details Product Name [Multi-Dose Drug Product Name] Batch Number…

Stability Documentation

SOP for Conducting Photostability Testing of Drug Products

SOP for Conducting Photostability Testing of Drug Products Procedure for Photostability Testing of Drug Products 1) Purpose The purpose of this SOP is to provide a detailed procedure for conducting photostability testing of drug products to evaluate their stability when exposed to light, in order to determine suitable packaging and storage conditions. 2) Scope This…

Stability Studies SOP

How to Prepare Stability Data for Compliance with FDA’s Quality by Design (QbD) Approach

How to Prepare Stability Data for Compliance with FDA’s Quality by Design (QbD) Approach Stability Data Preparation for Compliance with FDA’s QbD Approach Introduction The FDA’s Quality by Design (QbD) approach emphasizes building quality into pharmaceutical products through a systematic understanding of processes and product characteristics. Preparing stability data under the QbD framework involves integrating…

'How to' - Stability Studies

Analytical Data Record for Conducting Stability Studies for Hormone Replacement Therapies

Analytical Data Record for Conducting Stability Studies for Hormone Replacement Therapies Comprehensive Analytical Data Record for Hormone Replacement Therapy (HRT) Stability Studies This template documents the data collected from stability studies of hormone replacement therapies (HRT). It tracks parameters such as hormone potency, degradation products, and microbial stability under different conditions. Parameter Details Product Name…

Stability Documentation

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

How to Conduct Stability Studies for Dermatological Products in Compliance with Regulatory Guidelines Stability Testing for Dermatological Products: A Regulatory Guide Introduction Dermatological products, including creams, ointments, gels, and lotions, require specific stability testing to ensure their safety, efficacy, and quality. These products are often sensitive to environmental factors such as light, temperature, and humidity,…

'How to' - Stability Studies

How to Implement Stability Studies for Drug Products in Multi-Layered Packaging under Regulatory Guidelines

How to Implement Stability Studies for Drug Products in Multi-Layered Packaging under Regulatory Guidelines Stability Testing for Drug Products in Multi-Layered Packaging: Regulatory Compliance Guide Introduction Drug products in multi-layered packaging, such as blister packs or pouches, require specific stability testing to ensure their safety, efficacy, and quality throughout their shelf life. Multi-layered packaging can…

'How to' - Stability Studies

Analytical Data Record for Assessing the Stability of Chiral Drugs

Analytical Data Record for Assessing the Stability of Chiral Drugs Comprehensive Analytical Data Record for Stability Studies of Chiral Drugs This template is used to capture stability data for chiral drugs, focusing on enantiomeric purity, degradation, and stability across different storage conditions. Parameter Details Product Name [Chiral Drug Name] Batch Number [Batch Number] Test Parameters…

Stability Documentation

SOP for Determining the Impact of Temperature on Drug Stability

SOP for Determining the Impact of Temperature on Drug Stability Procedure for Evaluating the Effect of Temperature on Drug Stability 1) Purpose The purpose of this SOP is to provide a detailed procedure for determining the impact of temperature on the stability of drug substances and products. This evaluation helps in understanding the effects of…

Stability Studies SOP