Tag: Stability study protocol

How to Address Stability Testing for Breakthrough Therapy Drugs under FDA Guidelines

How to Address Stability Testing for Breakthrough Therapy Drugs under FDA Guidelines Stability Testing for Breakthrough Therapy Drugs: Navigating FDA Requirements Introduction Breakthrough therapy drugs are designated by the FDA for expedited development and review due to their potential to provide substantial improvement over existing therapies for serious conditions. These drugs require specific stability testing…

'How to' - Stability Studies

Packaging of Stability Samples Template

Packaging of Stability Samples Template Packaging Protocol for Stability Samples This template outlines the procedures for packaging pharmaceutical stability samples. Proper packaging ensures that the samples are protected from environmental factors that might affect their stability during the study period. Parameter Details Sample ID [Unique ID of the sample] Packaging Materials Used [List the materials…

Stability Documentation

How to Implement ICH Q1A(R2) for Stability Testing of APIs and Drug Products

How to Implement ICH Q1A(R2) for Stability Testing of APIs and Drug Products Applying ICH Q1A(R2) Guidelines for Stability Testing of APIs and Drug Products Introduction Stability testing is a critical component of the drug development process, ensuring that Active Pharmaceutical Ingredients (APIs) and finished drug products maintain their intended quality, safety, and efficacy over…

'How to' - Stability Studies

SOP for Conducting Accelerated Stability Testing of Pharmaceuticals

SOP for Conducting Accelerated Stability Testing of Pharmaceuticals Guidelines for Conducting Accelerated Stability Studies on Pharmaceuticals 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting accelerated stability testing of pharmaceuticals. The objective is to determine the shelf life and expiration date of drug products by subjecting them to conditions…

Stability Studies SOP

How to Conduct Stability Studies for Complex Generic Drug Products as per US FDA Guidelines

How to Conduct Stability Studies for Complex Generic Drug Products as per US FDA Guidelines Conducting Stability Studies for Complex Generic Drugs: A US FDA Compliance Guide Introduction Complex generic drugs, which include formulations such as liposomal drugs, injectables, and transdermal systems, require rigorous stability studies to ensure their safety, efficacy, and quality throughout their…

'How to' - Stability Studies

Climatic Condition Manual Logbook

Climatic Condition Manual Logbook Climatic Condition Manual Logbook for Pharmaceutical Storage Areas This template logs and monitors the manual recording of climatic conditions such as temperature and humidity in pharmaceutical storage or manufacturing environments. It ensures that the environmental conditions are maintained within acceptable limits to preserve product quality. Date Time Temperature (°C) Humidity (%)…

Stability Documentation

How to Prepare a Stability Testing Plan in Compliance with Global Regulatory Requirements

How to Prepare a Stability Testing Plan in Compliance with Global Regulatory Requirements Creating a Comprehensive Stability Testing Plan: A Global Regulatory Perspective Introduction A well-prepared stability testing plan is essential for ensuring that pharmaceutical products maintain their safety, efficacy, and quality throughout their shelf life. Compliance with global regulatory requirements, such as those set…

'How to' - Stability Studies

Monthly Summary Report Template

Monthly Summary Report Template Monthly Summary Report for Pharmaceutical Processes This template summarizes all key activities, deviations, and corrective actions taken during the month in pharmaceutical manufacturing or quality assurance processes. The report helps track trends and make data-driven decisions. Parameter Details Report Title Monthly Summary Report for [Department/Process Name] Reporting Period [Month/Year] Activities Summary…

Stability Documentation

How to Conduct Stability Testing for Ophthalmic Products under Regulatory Guidelines

How to Conduct Stability Testing for Ophthalmic Products under Regulatory Guidelines Ensuring Stability of Ophthalmic Products: A Regulatory Guide Introduction Ophthalmic products, including eye drops and ointments, require specific stability testing to ensure their safety, efficacy, and quality throughout their shelf life. These products are particularly sensitive to microbial contamination and environmental factors, making rigorous…

'How to' - Stability Studies

Temperature and Humidity Data Log

Temperature and Humidity Data Log Temperature and Humidity Data Log for Pharmaceutical Storage Areas This template records temperature and humidity data for pharmaceutical storage areas to ensure compliance with environmental conditions. The data log helps track deviations and ensures product quality remains intact during storage. Date Time Temperature (°C) Humidity (%) Recorded By Remarks DD/MM/YYYY…

Stability Documentation