Pharma Stability: Insights, Guidelines, and Expertise
SOP for Establishing Shelf Life Using Stability Data Procedure for Determining Shelf Life of Pharmaceuticals Using Stability Data 1) Purpose The purpose of this SOP is to provide guidelines for establishing the shelf life of pharmaceutical products using data obtained from stability studies. 2) Scope This SOP applies to all stability studies conducted to determine…
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How to Implement Stability Testing for Orally Inhaled and Nasal Drug Products (OINDP) under FDA Guidelines Ensuring Stability of Orally Inhaled and Nasal Drug Products: A Guide to FDA Compliance Introduction Orally Inhaled and Nasal Drug Products (OINDPs), including inhalers, nasal sprays, and nebulizers, are complex formulations that require rigorous stability testing to ensure their…
How to Conduct Stability Studies for Controlled Drugs under Regulatory Guidelines Ensuring Compliance in Stability Studies for Controlled Drugs Introduction Controlled drugs, including narcotics and psychotropics, require stringent stability testing to ensure their safety, efficacy, and quality throughout their shelf life. Regulatory authorities, such as the US DEA, FDA, and international bodies, provide specific guidelines…
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How to Address Stability Testing for Products under Emergency Use Authorization (EUA) Stability Testing for Products under EUA: Navigating Regulatory Requirements Introduction Emergency Use Authorization (EUA) allows for the use of medical products during public health emergencies, even when they have not completed the standard approval process. Stability testing for products under EUA is crucial…
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SOP for Performing Real-Time Stability Testing for Drug Substances Standard Procedure for Conducting Real-Time Stability Testing on Drug Substances 1) Purpose The purpose of this SOP is to provide a structured procedure for conducting real-time stability testing of drug substances to ensure their safety, efficacy, and quality throughout their shelf life under recommended storage conditions….
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How to Implement Stability Testing for High-Risk Drug Products under Regulatory Guidelines Stability Testing for High-Risk Drug Products: Regulatory Compliance Guide Introduction High-risk drug products, such as controlled substances, cytotoxic agents, and biologics, require stringent stability testing to ensure their safety, efficacy, and quality. Regulatory authorities, including the US FDA, EMA, and WHO, have established…
How to Conduct Stability Studies for Drugs with Narrow Therapeutic Index under US FDA Guidelines Stability Studies for Drugs with Narrow Therapeutic Index: A Guide to US FDA Compliance Introduction Drugs with a narrow therapeutic index (NTI) have a small margin between therapeutic and toxic doses, making precise and rigorous stability testing essential to ensure…
How to Implement Stability Testing for Non-Oral Dosage Forms in Compliance with Regulatory Guidelines Ensuring Compliance in Stability Testing for Non-Oral Dosage Forms Introduction Non-oral dosage forms, such as injectables, inhalers, transdermal patches, and ophthalmic solutions, present unique challenges in stability testing due to their distinct formulations, delivery mechanisms, and storage conditions. Ensuring compliance with…
SOP for Designing a Stability Study Protocol for Drug Products Procedure for Creating a Stability Study Protocol for Drug Products 1) Purpose The purpose of this SOP is to outline the standardized procedure for designing a stability study protocol for drug products. The aim is to ensure that all stability studies are conducted consistently and…
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How to Conduct Stability Testing for Biologics Under Biosimilar Regulatory Guidelines Stability Testing for Biologics: Adhering to Biosimilar Guidelines Introduction Biologics, including biosimilars, are complex molecules that require stringent stability testing to ensure their safety, efficacy, and quality. Stability studies for biosimilars must demonstrate that the product remains comparable to its reference biologic under specified…
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