Pharma Stability: Insights, Guidelines, and Expertise
SOP for Conducting In-Use Stability Testing Procedure for Performing In-Use Stability Testing of Drug Products 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting in-use stability testing of drug products to evaluate their stability during the period of use once the primary container is opened. 2) Scope This SOP…
How to Ensure Stability Studies Comply with Health Canada Guidelines Stability Testing for Drug Products: Compliance with Health Canada Requirements Introduction Stability studies are essential to demonstrate that a drug product will maintain its quality, safety, and efficacy throughout its shelf life. Health Canada provides specific guidelines for conducting stability studies for drug products marketed…
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How to Apply ICH Q1A(R2) Guidelines for Stress Testing Implementing ICH Q1A(R2) Guidelines for Stress Testing of Drug Substances and Products Introduction Stress testing is a critical part of stability studies designed to identify the degradation products and understand the intrinsic stability of a drug substance or product. The ICH Q1A(R2) guidelines provide specific recommendations…
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How to Conduct Stability Studies for Biosimilars as per EMA Guidelines Guidelines for Stability Testing of Biosimilars in Compliance with EMA Introduction Biosimilars are biological medicines highly similar to an already approved biological reference product. Conducting stability studies for biosimilars is crucial to demonstrate that they maintain the same quality, safety, and efficacy as their…
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SOP for Determining the Shelf Life of Parenteral Products Procedure for Determining Shelf Life of Parenteral Drug Products 1) Purpose The purpose of this SOP is to provide a standardized procedure for determining the shelf life of parenteral drug products through stability studies under various environmental conditions. 2) Scope This SOP applies to all parenteral…
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How to Implement Stability Testing for Orphan Drugs Under US FDA Guidelines Guidelines for Stability Testing of Orphan Drugs in Compliance with US FDA Introduction Orphan drugs, which are intended to treat rare diseases, have unique regulatory requirements, including stability testing to ensure they meet quality, safety, and efficacy standards. The US FDA provides specific…
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How to Apply FDA Guidance for Industry on Drug Product Stability Testing Implementing FDA Guidance for Drug Product Stability Testing Introduction Drug product stability testing is essential for ensuring that a drug maintains its intended quality, safety, and efficacy throughout its shelf life. The US FDA provides detailed guidance for industry on conducting stability testing,…
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How to Conduct Stability Studies in Compliance with Japanese Regulatory Requirements (PMDA) Guidelines for Stability Testing in Accordance with PMDA Requirements Introduction Stability studies are essential for demonstrating that drug products meet quality, safety, and efficacy standards over their intended shelf life. The Pharmaceutical and Medical Devices Agency (PMDA) in Japan has specific guidelines for…
SOP for Performing Long-Term Stability Testing Procedure for Conducting Long-Term Stability Testing of Drug Products 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting long-term stability testing of drug products to evaluate their shelf life and storage conditions under normal environmental conditions. 2) Scope This SOP applies to all…
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How to Manage Stability Testing of Post-Approval Changes According to US FDA Guidelines Conducting Stability Testing for Post-Approval Changes per FDA Guidelines Introduction After a drug product receives marketing approval, manufacturers may need to implement changes to the product or its manufacturing process, such as changes in formulation, packaging, or manufacturing site. The US FDA…