Tag: Stability Storage

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

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

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

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

How to Address Stability Testing for Combination Antiretroviral Therapy (cART) under Regulatory Guidelines

How to Address Stability Testing for Combination Antiretroviral Therapy (cART) under Regulatory Guidelines Stability Testing for Combination Antiretroviral Therapy: A Regulatory Guide Introduction Combination Antiretroviral Therapy (cART) is a critical treatment regimen for managing HIV/AIDS, involving the use of multiple antiretroviral drugs in a single formulation. Stability testing for cART is essential to ensure the…

'How to' - Stability Studies

How to Conduct Stability Testing for Biosimilars in Compliance with WHO Guidelines

How to Conduct Stability Testing for Biosimilars in Compliance with WHO Guidelines Stability Testing for Biosimilars: A WHO Compliance Guide Introduction Biosimilars, which are biological products highly similar to their reference biologics, require comprehensive stability testing to ensure their safety, efficacy, and quality. The World Health Organization (WHO) provides guidelines for stability testing of biosimilars,…

'How to' - Stability Studies

How to Implement Stability Testing for Pediatric Formulations under US FDA and EMA Guidelines

How to Implement Stability Testing for Pediatric Formulations under US FDA and EMA Guidelines Stability Testing for Pediatric Formulations: A Regulatory Compliance Guide Introduction Pediatric formulations, which are specifically designed for children, require tailored stability testing to ensure their safety, efficacy, and quality. The US FDA and EMA have established guidelines that address the unique…

'How to' - Stability Studies

How to Conduct Stability Studies for Drug Products Stored at Subzero Temperatures under Regulatory Guidelines

How to Conduct Stability Studies for Drug Products Stored at Subzero Temperatures under Regulatory Guidelines Stability Studies for Drug Products at Subzero Temperatures: A Regulatory Guide Introduction Drug products stored at subzero temperatures, such as biologics, vaccines, and certain advanced therapies, require specific stability studies to ensure their safety, efficacy, and quality throughout their shelf…

'How to' - Stability Studies