The Ultimate Resource for Pharmaceutical SOPs and Best Practices
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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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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