The Ultimate Resource for Pharmaceutical SOPs and Best Practices
This Standard Operating Procedure (SOP) outlines the procedure for optimizing the high shear granulation process in tablet manufacturing. The objective is to ensure uniformity in granule size, improve batch-to-batch consistency, and enhance the quality of the final tablets.
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The purpose of this Standard Operating Procedure (SOP) is to define the methodology for fluidized bed granulation in tablet manufacturing. Fluidized bed granulation is used to enhance the flow properties of powders, improve the uniformity of blends, and ensure the consistency of the final tablet formulation.
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This Standard Operating Procedure (SOP) outlines the process for monitoring and adjusting tablet compression force during the tablet manufacturing process. Proper compression force ensures that tablets are formed with the desired hardness, weight, and consistency, meeting quality specifications.
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This Standard Operating Procedure (SOP) outlines the steps necessary to achieve consistent tablet thickness during the tablet manufacturing process. Ensuring uniform tablet thickness is essential for product quality, dosage accuracy, and efficient packaging.
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This Standard Operating Procedure (SOP) defines the steps for ensuring the uniform distribution of Active Pharmaceutical Ingredients (APIs) in tablet granules during the manufacturing process. Achieving uniformity in API content is critical for maintaining consistent drug potency, ensuring patient safety, and meeting regulatory requirements.
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The purpose of this Standard Operating Procedure (SOP) is to outline the process for using a multi-tooling tablet press to manufacture tablets in high volume production. This SOP ensures efficient operation, consistency in tablet quality, and compliance with GMP standards.
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The purpose of this Standard Operating Procedure (SOP) is to provide a systematic approach to troubleshooting issues that may arise during tablet manufacturing. The goal is to identify and resolve problems such as irregular tablet weight, hardness, capping, or lamination, ensuring consistent production quality and minimal downtime.
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The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for utilizing Process Analytical Technology (PAT) tools for real-time monitoring of the tablet manufacturing process. The goal is to enhance process control, improve product quality, and ensure consistent production of tablets by continuously monitoring key parameters.
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The purpose of this Standard Operating Procedure (SOP) is to outline the process for implementing lean manufacturing principles in tablet production. The goal is to optimize efficiency, reduce waste, and improve overall product quality by adopting lean techniques across the manufacturing process.
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The purpose of this Standard Operating Procedure (SOP) is to define the procedure for validating the drying time for tablet granules to ensure consistency and uniformity in tablet quality. The SOP ensures that the drying process is optimized to achieve the desired moisture content and prevent potential product degradation.
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