The Ultimate Resource for Pharmaceutical SOPs and Best Practices
To define the procedure for validating the retention time of the active pharmaceutical ingredient (API) in tablet formulations using High-Performance Liquid Chromatography (HPLC), ensuring consistency and accuracy in API identification and quantification.
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To define the procedure for performing shelf-life stability testing under accelerated conditions to assess the stability of tablet formulations over time and predict their shelf-life.
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To define the procedure for conducting high-pressure homogenization analysis of coated tablets, ensuring uniform distribution of active pharmaceutical ingredients (APIs) and excipients within the tablet coating.
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To define the procedure for testing the flowability of granules and powder used in tablet formulations, ensuring optimal flow characteristics for processing and uniformity in tablet manufacturing.
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To define the procedure for the calibration of analytical instruments used in Quality Control (QC) laboratories, ensuring that all equipment operates accurately and meets regulatory standards.
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To establish the procedure for conducting a visual inspection of finished tablets to identify any defects in appearance, coating, or shape that may affect product quality and compliance with specifications.
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To define the procedure for controlling tablet weight during the compression process, ensuring that the final tablet weight meets the specified target range.
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To define the procedure for monitoring tablet hardness during the manufacturing process, ensuring that the final product meets the specified hardness requirements.
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To define the procedure for real-time monitoring and control of tablet thickness during the compression process, ensuring uniformity and adherence to product specifications.
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To define the procedure for monitoring the uniformity of the coating process in film-coated tablets to ensure that tablets meet the required coating specifications for quality, consistency, and appearance.
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