Pharma Stability: Insights, Guidelines, and Expertise
The purpose of this SOP is to provide a detailed procedure for conducting photostability testing of drug products to evaluate their stability when exposed to light, in order to determine suitable packaging and storage conditions.
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The purpose of this SOP is to provide a detailed procedure for determining the impact of temperature on the stability of drug substances and products. This evaluation helps in understanding the effects of various temperature conditions on the quality, safety, and efficacy of the drug.
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The purpose of this SOP is to provide guidelines for establishing the shelf life of pharmaceutical products using data obtained from stability studies.
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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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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 according to regulatory requirements to determine the shelf life and storage conditions of drug products.
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The purpose of this SOP is to provide a standardized procedure for conducting accelerated stability testing of pharmaceuticals. The objective is to determine the shelf life and expiration date of drug products by subjecting them to conditions that accelerate their degradation and chemical changes.
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Initiating a Stability Study Purpose The purpose of this Standard Operating Procedure (SOP) is to provide a step-by-step process for initiating a stability study, ensuring that all necessary preparations and documentation are completed to comply with regulatory requirements. Scope This SOP applies to all stability studies conducted on drug substances and drug products within the…
Contents of a Stability Protocol Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the essential components and format required for a stability protocol to ensure comprehensive and consistent documentation for stability studies. Scope This SOP applies to all stability protocols prepared for stability studies on drug substances and drug products within…
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Setting the ‘Start Date’ for a Stability Study Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for setting the ‘start date’ for a stability study to ensure consistency and compliance with regulatory requirements. Scope This SOP applies to all stability studies conducted on drug substances and drug products within…
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Establishing With-drawal dates for Stability Study sample Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the process for determining the ‘due dates’ for various milestones in a stability study protocol to ensure timely completion and regulatory compliance. Scope This SOP applies to all stability studies conducted on drug substances and drug…
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