The Ultimate Resource for Pharmaceutical SOPs and Best Practices
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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To outline the procedure for conducting physical tests on immediate release tablets, ensuring that they meet the required specifications for physical properties such as weight, hardness, friability, and disintegration.
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To provide a standardized method for conducting dissolution testing of film-coated tablets, ensuring that the tablets release their active pharmaceutical ingredient (API) in a controlled and predictable manner.
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To provide the procedure for conducting friability testing on sugar-coated tablets to ensure that they meet the required mechanical strength and durability criteria.
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To provide a standardized procedure for testing the uniformity of dosage units in tablets, ensuring that each tablet contains the correct amount of active pharmaceutical ingredient (API) within the established limits.
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