Pharma Stability: Insights, Guidelines, and Expertise
SOP for Implementing Stability Testing for Drugs with Novel Delivery Systems under US FDA Guidelines Guidelines for Stability Testing of Drugs with Novel Delivery Systems as per US FDA Guidelines 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for conducting stability testing for drugs with novel delivery systems in…
SOP for Conducting Stability Studies for Drug Products in Compliance with Indian Regulatory Requirements (CDSCO) Guidelines for Stability Testing of Drug Products as per Indian Regulatory Requirements (CDSCO) 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for conducting stability studies for drug products in accordance with the Central Drugs…
Understanding the Tip: Why monitoring API solid state is essential: APIs may exist in multiple physical forms such as crystalline polymorphs, solvates, hydrates, or amorphous states—each with unique solubility, bioavailability, and stability characteristics. During storage, environmental stress like heat and humidity can trigger transitions from one form to another, affecting dissolution rate, absorption, and even…
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SOP for Applying ICH Guidelines to Stability Testing for Radiopharmaceuticals Guidelines for Stability Testing of Radiopharmaceuticals as per ICH Guidelines 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for conducting stability testing of radiopharmaceuticals in accordance with the ICH guidelines. This SOP ensures that stability data supports the quality,…
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Understanding the Tip: What are container orientation studies and why they matter: Container orientation studies involve storing pharmaceutical products in different physical positions—upright, inverted, or horizontal—to assess packaging integrity and leakage or migration risk during stability testing. These studies simulate worst-case scenarios that may occur during storage, shipment, or use. They are especially critical for…
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SOP for Implementing Stability Testing for Cell Therapy Products under ICH Q5A Guidelines for Stability Testing of Cell Therapy Products as per ICH Q5A 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for conducting stability testing for cell therapy products in accordance with the ICH Q5A guidelines. This SOP…
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Understanding the Tip: What is WHO TRS 1010 and why it matters: WHO Technical Report Series No. 1010 outlines international expectations for the design, execution, and documentation of pharmaceutical stability studies. It builds on ICH Q1A(R2) and provides additional context for markets in developing countries, tropical zones, and WHO-prequalified product categories. Aligning with TRS 1010…
Read More “Align with WHO TRS 1010 for Stability Compliance in Global Submissions” »
SOP for Conducting Stability Testing for Gene Therapy Products as per FDA Guidelines Guidelines for Stability Testing of Gene Therapy Products as per FDA Guidelines 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for conducting stability testing for gene therapy products in accordance with US FDA requirements. This SOP…
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SOP for Performing Stability Studies for Vaccines in Compliance with WHO Guidelines Guidelines for Stability Testing of Vaccines as per WHO Guidelines 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for conducting stability studies for vaccines in accordance with World Health Organization (WHO) guidelines. This SOP ensures that stability…
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SOP for Conducting Stability Studies for Injectable Products per ICH Guidelines Guidelines for Stability Testing of Injectable Products as per ICH Guidelines 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for conducting stability studies for injectable drug products in accordance with the International Council for Harmonisation (ICH) guidelines. This…
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