SOPs for API Manufacturing V 2.0

To lay down the procedure for the preparation of mobile phases used in HPLC analysis to ensure consistency, accuracy, and compliance with cGMP in the QC laboratory for API manufacturing.
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To lay down the procedure for internal and external calibration of analytical balances used in the Quality Control (QC) laboratory to ensure that all weighing performed is accurate and traceable to national standards.
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To establish a standard procedure for performing system suitability testing (SST) in HPLC analysis before initiating sample analysis of API raw materials, intermediates, or finished products to verify the performance of the chromatographic system.
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To define the procedure for the determination and quantification of residual solvents in Active Pharmaceutical Ingredients (APIs) using Gas Chromatography (GC), ensuring compliance with ICH Q3C and applicable pharmacopeial limits.
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To establish a standardized procedure for performing impurity profiling of Active Pharmaceutical Ingredients (APIs) using HPLC, ensuring accurate identification and quantification of known, unknown, and specified impurities as per regulatory and pharmacopeial requirements.
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To define the procedure for determining Loss on Drying (LOD) and moisture content in Active Pharmaceutical Ingredients (APIs) using both conventional oven method and Karl Fischer titration, ensuring consistency and regulatory compliance.
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To define a standardized procedure for the accurate determination of water content in pharmaceutical substances, excipients, and APIs using Karl Fischer (KF) titration, ensuring reproducibility and regulatory compliance.
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To establish a standardized procedure for the sampling and testing of raw materials used in API manufacturing to ensure quality, identity, and compliance with approved specifications before use in production.
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To define the procedure for conducting stability testing of Active Pharmaceutical Ingredient (API) batches to assess product integrity over time and establish or confirm shelf-life in accordance with ICH Q1 guidelines.
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The purpose of this SOP is to establish a standardized procedure for qualification, handling, storage, and periodic review of reference standards used in the analysis of Active Pharmaceutical Ingredients (APIs). This ensures that all reference standards are reliable, traceable, and meet regulatory and internal quality requirements.
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