The Ultimate Resource for Pharmaceutical SOPs and Best Practices
To establish uniform guidelines for the frequency and quantity of samples to be collected during various stages of API manufacturing for in-process checks, intermediate testing, and final product evaluation.
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To define the procedure for real-time yield monitoring during chemical reactions in the manufacturing of Active Pharmaceutical Ingredients (APIs) in order to assess process efficiency, trigger corrective actions, and support in-process control.
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To define the procedure for using conductivity meters in API manufacturing processes to measure and monitor the conductivity of solutions during synthesis, purification, and equipment cleaning to ensure process control and GMP compliance.
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To define the procedure for routine calibration of pH meters used in production areas for accurate and reliable pH measurements in process solutions during API manufacturing.
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To establish a standard procedure for documenting all in-process control (IPC) test results generated during the manufacture of Active Pharmaceutical Ingredients (APIs), ensuring traceability, accuracy, and compliance with GMP and data integrity principles.
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To establish a procedure for the visual and olfactory assessment of color and odor in API intermediates to ensure product consistency and detect abnormal process variations during manufacturing.
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To outline a standard procedure for performing Loss on Drying (LOD) testing during the drying stage of API manufacturing for real-time monitoring of residual moisture and to determine the endpoint of drying.
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To describe a standardized method for measuring the conductivity of process solutions in API manufacturing to monitor ionic strength, validate cleaning processes, and ensure consistency in intermediate reactions and aqueous washings.
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To describe the standard procedure for preparing Thin Layer Chromatography (TLC) plates and interpreting results during in-process checks, reaction monitoring, and identification of raw materials or intermediates in API manufacturing.
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To define the standard procedure for monitoring and controlling pH during reaction stages in API manufacturing to ensure reaction efficiency, reproducibility, and product quality as per the validated process parameters.
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