Pharma Stability: Insights, Guidelines, and Expertise
SOP for Assessing Stability for Polymorphic Drugs Guidelines for Stability Testing of Polymorphic Drugs 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability studies on polymorphic drugs. Stability testing ensures that the drug’s polymorphic form remains stable and does not undergo any undesired changes under various storage conditions…
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Bridging Regional Differences: Comparing FDA, EMA, and ASEAN Guidelines How to Navigate Regional Differences: Comparing FDA, EMA, and ASEAN Guidelines Introduction Pharmaceutical stability testing is governed by regulatory guidelines that vary across regions. While harmonized frameworks like ICH Q1A(R2) provide a foundation, regional agencies such as the FDA (United States), EMA (European Union), and ASEAN…
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What’s New in ASEAN Stability Guidelines for 2023? Exploring Updates in ASEAN Stability Guidelines for 2023 Introduction The ASEAN Stability Guidelines are a cornerstone of pharmaceutical regulation in Southeast Asia, ensuring that drug products remain safe, effective, and high-quality under the region’s unique climatic conditions. As the pharmaceutical industry evolves, so do the regulatory frameworks…
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SOP for Conducting Stability Studies for Single-Dose Vials Guidelines for Stability Testing of Single-Dose Vials 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability studies on single-dose vials. Stability testing is necessary to ensure that the product in the vials maintains its safety, efficacy, and quality under various…
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A Step-by-Step Guide to ICH Q1E: Evaluation of Stability Data Step-by-Step Guide to Evaluating Stability Data Using ICH Q1E Introduction Stability testing is a cornerstone of pharmaceutical development, ensuring that products maintain their quality, safety, and efficacy throughout their shelf life. While ICH Q1A(R2) provides guidelines for conducting stability studies, ICH Q1E focuses on the…
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PIC/S Guidelines: Harmonizing Global Stability Testing Practices Harmonizing Global Stability Testing Practices: The Role of PIC/S Guidelines Introduction In the pharmaceutical industry, stability testing ensures that products maintain their safety, quality, and efficacy throughout their shelf life. The Pharmaceutical Inspection Co-operation Scheme (PIC/S) plays a critical role in harmonizing these testing practices globally. By providing…
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SOP for Performing Stability Studies for Controlled-Temperature Products Guidelines for Stability Testing of Controlled-Temperature Products 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability studies on products that require controlled-temperature conditions. Stability testing is essential to ensure that these products maintain their safety, efficacy, and quality throughout their…
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TGA Guidelines for Stability Testing in Pharmaceuticals: An Overview Comprehensive Overview of TGA Stability Testing Guidelines in Pharmaceuticals Introduction Stability testing is a vital aspect of pharmaceutical product development, ensuring that medicines remain effective, safe, and of high quality throughout their shelf life. In Australia, the Therapeutic Goods Administration (TGA) oversees the regulation of stability…
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SOP for Conducting Stability Studies for Drug-Eluting Stents Guidelines for Stability Testing of Drug-Eluting Stents 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability studies on drug-eluting stents. Stability testing is necessary to ensure that the drug coating on the stents maintains its safety, efficacy, and quality under…
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EMA Stability Guidelines: Navigating European Market Requirements Understanding EMA Stability Guidelines for the European Market Introduction Stability testing is a fundamental aspect of pharmaceutical development, ensuring that drugs remain safe, effective, and of high quality throughout their shelf life. In Europe, the European Medicines Agency (EMA) has established stringent stability guidelines to regulate drug approvals…
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