Pharma Stability: Insights, Guidelines, and Expertise
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…
How to Apply ICH Q1C Guidelines for Stability Testing of New Dosage Forms Implementing ICH Q1C Guidelines for Stability Testing of New Dosage Forms Introduction Stability testing is a vital process for establishing the shelf life and storage conditions of new dosage forms of existing drug substances. The ICH Q1C guideline provides specific instructions on…
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How to Develop Stability Study Reports for ANDA Submissions Creating Stability Study Reports for ANDA Submissions: A Comprehensive Guide Introduction Stability study reports are a critical component of Abbreviated New Drug Application (ANDA) submissions to the US FDA, providing evidence that a generic drug product maintains the same quality, safety, and efficacy as its reference…
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SOP for Assessing the Effect of pH on Drug Stability Procedure for Evaluating the Effect of pH on Drug Stability 1) Purpose The purpose of this SOP is to provide a standardized procedure for assessing the impact of pH on the stability of drug substances and products to determine optimal formulation conditions and storage environments….
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How to Document Stability Studies for New Drug Applications (NDAs) to the US FDA Documenting Stability Studies for NDAs: A Guide to FDA Compliance Introduction Stability studies are a critical component of a New Drug Application (NDA) submitted to the US FDA, providing evidence that a drug product will maintain its quality, safety, and efficacy…
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How to Conduct Stability Studies for Modified Release Products per FDA and ICH Guidelines Stability Testing for Modified Release Products: FDA and ICH Requirements Introduction Modified release products, such as extended-release or delayed-release formulations, require specific stability studies to ensure that they maintain their release profile, potency, and safety throughout their shelf life. Both the…
How to Design Stability Studies for Combination Products as per Regulatory Guidelines Creating Stability Studies for Combination Products: A Regulatory Perspective Introduction Combination products, which include a combination of drug, device, or biological products, pose unique challenges for stability testing. Regulatory authorities such as the US FDA and EMA have specific guidelines for conducting stability…
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SOP for Conducting Stability Testing for Solid Oral Dosage Forms Procedure for Conducting Stability Studies on Solid Oral Dosage Forms 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability studies on solid oral dosage forms to evaluate their shelf life and storage conditions under various environmental factors such…
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How to Implement ICH Q1E for Stability Data Evaluation Applying ICH Q1E Guidelines for Effective Stability Data Evaluation Introduction The ICH Q1E guideline provides recommendations on the evaluation and extrapolation of stability data to support the shelf life of drug substances and products. Proper implementation of these guidelines ensures that stability data is interpreted correctly…
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How to Conduct Stability Studies for Drug Substances Under US FDA Guidelines Stability Testing of Drug Substances as per US FDA Requirements Introduction Stability studies for drug substances are essential to demonstrate that the active pharmaceutical ingredient (API) remains stable and maintains its intended quality, safety, and efficacy over its shelf life. The US FDA…
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