Tag: Stability testing requirements

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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Selection and Management of Container-Liner-Closure Systems Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for selecting and managing container-liner-closure systems used in stability studies. This ensures that the packaging systems protect the integrity and quality of the drug product throughout the stability study. Scope This SOP applies to all…

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Qualification and Certification of Container-Liner-Closure Systems for Stability Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for the certification of container-liner-closure systems used in stability studies. This ensures that the packaging systems are qualified and certified to maintain the integrity and quality of the drug product throughout the…

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Documentation and Reporting of Stability Study Test Results Purpose The purpose of this Standard Operating Procedure (SOP) is to describe the process for documenting and reporting the test results of stability studies. This ensures that the data is accurately recorded, analyzed, and communicated in a standardized format for regulatory compliance and decision-making. Scope This SOP…

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Management of Abnormal and OOS Results in Stability Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for identifying, investigating, and managing abnormal or out-of-specification (OOS) results observed during stability studies. This ensures that all OOS results are handled in a consistent, documented, and compliant manner. Scope This SOP…

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Management of Stability Chamber Malfunctions and Storage Condition Deviations Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for managing and resolving stability chamber breakdowns or deviations from specified storage conditions during stability studies. This ensures the integrity of the study is maintained and that corrective actions are taken promptly….

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Documentation of Climatic Conditions for Stability Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish the process for accurately recording and documenting the climatic conditions (temperature, humidity, etc.) during stability studies. This ensures that the environmental conditions are consistently monitored and reported, maintaining the integrity of the stability data. Scope This…

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Monitoring and Management of Temperature and Humidity Records Purpose The purpose of this Standard Operating Procedure (SOP) is to establish the process for reviewing and controlling temperature and humidity recording charts used in stability studies. This ensures that environmental conditions are consistently monitored, recorded accurately, and deviations are promptly addressed to maintain the integrity of…

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