The Ultimate Resource for Pharmaceutical SOPs and Best Practices
The purpose of this Standard Operating Procedure (SOP) is to define the procedure for detecting the end-point during the tablet compression process. The goal is to ensure that tablets are compressed to the correct hardness, weight, and thickness, and to determine when to stop the compression process to maintain product consistency and quality.
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The purpose of this Standard Operating Procedure (SOP) is to outline the process for testing the homogeneity of the blend used in the direct compression process. The objective is to ensure that the blend is uniformly mixed to ensure uniformity of the active pharmaceutical ingredient (API) in the final tablet dosage form.
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The purpose of this Standard Operating Procedure (SOP) is to define the procedure for optimizing surface coating uniformity during tablet manufacturing. The goal is to ensure that the coating is applied evenly across all tablets, which is critical for consistent release and appearance.
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The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the calibration of the Fluid Bed Processor used in the granulation process of tablet manufacturing. Calibration ensures that the equipment performs accurately and consistently, which is critical for producing uniform granules with the desired properties.
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To define the procedure for manufacturing multi-layer tablets, ensuring proper layer formation, uniformity, and the desired therapeutic release profile.
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To provide guidelines for the use of automated spray coating systems to ensure uniform and consistent coating application during tablet manufacturing.
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To validate the post-coating drying process, ensuring that the coated tablets are dried to the required specifications for stability and quality.
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To define the procedure for scaling up the sugar coating process from laboratory or pilot scale to commercial production, ensuring consistent quality and coating uniformity.
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To outline the procedure for inspecting tablets post-compression, ensuring that the tablets meet the required physical and mechanical specifications.
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To outline the procedure for in-line weight monitoring during tablet compression, ensuring that tablets meet the specified weight requirements during the manufacturing process.
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