Tag: Stability testing challenges

Scheduling and Environmental Conditions for US Pivotal/Bioequivalence Stability Testing Purpose The purpose of this Standard Operating Procedure (SOP) is to define the intervals and climatic conditions for conducting pivotal or bioequivalence stability studies of drug substances and drug products intended for the US market. This ensures compliance with regulatory guidelines and generates reliable stability data…

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Scheduling and Environmental Conditions for US Stability Testing Purpose The purpose of this Standard Operating Procedure (SOP) is to establish the intervals and climatic conditions for conducting stability studies of drug substances and drug products intended for the US market. This ensures compliance with regulatory guidelines and generates reliable stability data. Scope This SOP applies…

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Scheduling and Environmental Conditions for US Validation/PM Stability Testing Purpose The purpose of this Standard Operating Procedure (SOP) is to establish the intervals and climatic conditions for conducting validation or post-marketing (PM) stability studies of drug substances and drug products intended for the US market. This ensures compliance with regulatory guidelines and generates reliable stability…

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Stability Testing of Reference Listed Drug (RLD) Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the process for placing the Reference Listed Drug (RLD) on stability testing. This is to ensure that the RLD is evaluated under specified conditions to generate stability data necessary for regulatory submissions and comparison with test…

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Packaging and Labeling of Stability Testing Samples Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for packaging stability samples. This ensures that the samples are protected from environmental factors and remain in a suitable condition for stability testing. Scope This SOP applies to all stability samples, including drug substances…

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Monitoring Storage Conditions for Stability Samples Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for monitoring storage conditions of stability samples. This ensures that stability samples are maintained under specified conditions to generate accurate and reliable stability data. Scope This SOP applies to all stability chambers and storage units…

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Calibration Procedure for Stability Chambers Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for the calibration of stability chambers. This ensures that stability chambers are functioning correctly and maintaining the required environmental conditions for stability testing. Scope This SOP applies to all stability chambers used for housing stability samples,…

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Sampling and Analysis of Pivotal Tablet Batches for Stability Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to describe the procedures for sampling and testing pivotal batches of tablet dosage forms. This ensures that stability studies are conducted under controlled and reproducible conditions, generating reliable data for regulatory submission. Scope This SOP…

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Procedure for Sampling and Testing Pivotal Batches of Capsules Purpose The purpose of this Standard Operating Procedure (SOP) is to establish standardized procedures for the sampling and testing of pivotal batches of capsule dosage forms. This ensures consistency, reliability, and compliance with regulatory requirements. Scope This SOP applies to all pivotal batches of capsule dosage…

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Sampling and Analysis of Pivotal Batches for Stability Studies – Powder and Syrups for Reconstitution Purpose The purpose of this Standard Operating Procedure (SOP) is to describe the procedures for sampling and testing pivotal batches of powder and syrups intended for reconstitution. This ensures that stability studies are conducted under controlled and reproducible conditions, generating…

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