Author: digi

How to Conduct Shelf Life Studies for Temperature-Sensitive Products

How to Conduct Shelf Life Studies for Temperature-Sensitive Products A Step-by-Step Guide to Shelf Life Studies for Temperature-Sensitive Products Introduction: Why Shelf Life Studies Matter for Temperature-Sensitive Products Temperature-sensitive products, including biologics, vaccines, and certain small molecules, require stringent stability testing to ensure efficacy and safety under specific storage conditions. These products are highly susceptible…

Shelf Life and Expiry Dating

SOP for Performing Stability Studies for Ophthalmic Ointments

SOP for Performing Stability Studies for Ophthalmic Ointments Guidelines for Stability Testing of Ophthalmic Ointments 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability studies on ophthalmic ointments. Stability testing is essential to ensure that these ointments maintain their safety, efficacy, and quality under various storage conditions throughout…

Stability Studies SOP

How to Conduct Thermal Cycling Tests for Controlled Substances

How to Conduct Thermal Cycling Tests for Controlled Substances Step-by-Step Guide to Thermal Cycling Tests for Controlled Substances Introduction to Thermal Cycling Tests Thermal cycling tests simulate the temperature fluctuations that controlled substances may experience during storage and transportation. These tests are critical for evaluating the stability and integrity of controlled substances under real-world conditions,…

Types of Stability Studies

Addressing Shelf Life Challenges in Multinational Drug Approvals

Addressing Shelf Life Challenges in Multinational Drug Approvals Expert Insights on Overcoming Shelf Life Challenges in Multinational Drug Approvals Introduction: The Complexities of Multinational Drug Approvals Global pharmaceutical markets demand that drug products meet diverse regulatory standards while maintaining consistent quality, safety, and efficacy. One of the most critical aspects of multinational drug approvals is…

Shelf Life and Expiry Dating

WHO Guidelines for Stability Testing: A Comprehensive Overview

WHO Guidelines for Stability Testing: A Comprehensive Overview Comprehensive Overview of WHO Stability Testing Guidelines Introduction The World Health Organization (WHO) provides a global framework for stability testing, ensuring the safety, quality, and efficacy of pharmaceutical products in diverse climatic conditions. WHO stability testing guidelines, outlined in the “Stability Testing of Active Pharmaceutical Ingredients and…

Regulatory Guidelines

How to Conduct Accelerated Testing for Packaging Material Degradation

How to Conduct Accelerated Testing for Packaging Material Degradation A Comprehensive Guide to Accelerated Testing for Packaging Material Degradation Introduction In the pharmaceutical industry, packaging materials must provide robust protection against environmental factors to ensure product stability and safety. Accelerated testing is a crucial process that evaluates the long-term performance of packaging materials by exposing…

Packaging - Containers - Closers

Developing Stability Testing Programs for Emerging Markets

Developing Stability Testing Programs for Emerging Markets Innovative Approaches to Stability Testing for Emerging Pharmaceutical Markets Introduction to Stability Testing for Emerging Markets Emerging markets, characterized by rapid economic growth and expanding healthcare access, represent significant opportunities for pharmaceutical companies. However, these regions often have diverse climatic conditions, regulatory requirements, and distribution challenges that make…

Types of Stability Studies

How ICH Guidelines Shape Expiry Date Determination Globally

How ICH Guidelines Shape Expiry Date Determination Globally Exploring the Global Impact of ICH Guidelines on Expiry Date Determination Introduction: The Importance of ICH Guidelines in Stability Testing Expiry date determination is a critical component of pharmaceutical development, ensuring that drug products remain safe and effective throughout their lifecycle. The International Council for Harmonisation of…

Shelf Life and Expiry Dating

Developing Comprehensive SOPs for API Stability Studies

Developing Comprehensive SOPs for API Stability Studies How to Develop Comprehensive SOPs for API Stability Studies Introduction to SOPs in API Stability Studies Standard Operating Procedures (SOPs) are critical documents that ensure consistency, accuracy, and regulatory compliance in API stability studies. These procedures provide detailed instructions for conducting stability testing, analyzing data, and managing deviations,…

Stability Studies - API

PIC/S Guidelines for Good Manufacturing Practices in Stability Testing

PIC/S Guidelines for Good Manufacturing Practices in Stability Testing Understanding PIC/S Guidelines for GMP in Stability Testing Introduction Stability testing is a critical component of pharmaceutical development and manufacturing, ensuring that products maintain their quality, safety, and efficacy throughout their lifecycle. The Pharmaceutical Inspection Co-operation Scheme (PIC/S) plays a significant role in harmonizing Good Manufacturing…

Regulatory Guidelines