Tablets: SOP for Granulation Process for Immediate Release Tablets – V 2.0
To establish the granulation process for immediate release tablets, ensuring uniformity, stability, and compliance with GMP requirements.
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To establish the granulation process for immediate release tablets, ensuring uniformity, stability, and compliance with GMP requirements.
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To establish a standardized, GMP-compliant method for setting up and operating the wet granulation equipment, ensuring optimal granule formation and product quality.
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To define the procedure for the dry granulation method in tablet manufacturing, ensuring uniformity, integrity, and compliance with GMP standards.
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The purpose of this SOP is to define the process for preparing the binder solution used in the granulation of tablets. It ensures that the binder is prepared in a consistent manner, meeting the required quality standards and facilitating uniform granule formation.
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To outline the procedure for screening and milling granules for tablet manufacturing, ensuring uniform particle size distribution and optimal processing for the subsequent tablet compression step.
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To establish a standardized method for the lubrication of tablet granules to ensure smooth tablet compression, preventing sticking and improving tablet flowability during the compression process.
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To establish a standardized procedure for the tablet compression process, ensuring that tablets are compressed to the required weight, hardness, and other quality specifications.
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This SOP defines the procedure for monitoring the hardness of tablets during the compression process, ensuring tablets meet the required hardness specifications for optimal product quality and performance.
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To provide a standardized approach for troubleshooting and resolving capping and lamination issues during the tablet compression process, ensuring that all tablets meet the required quality specifications.
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To outline the process for calibrating and setting up the coating machine, ensuring uniform coating of tablets, and that all operational parameters are met according to the product specifications.
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