The Ultimate Resource for Pharmaceutical SOPs and Best Practices
To lay down a uniform procedure for the preparation, labeling, qualification, usage, and storage of working standards derived from primary/reference standards used in the analytical testing of Active Pharmaceutical Ingredients (APIs).
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To establish a clear and standardized procedure for the documentation, review, and approval of analytical test results generated during Quality Control (QC) analysis of raw materials, intermediates, and Active Pharmaceutical Ingredients (APIs).
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To establish a systematic procedure for handling Out-of-Specification (OOS) results generated during testing of raw materials, intermediates, and final Active Pharmaceutical Ingredients (APIs), ensuring thorough investigation, documentation, and compliance with applicable regulations.
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To define a systematic procedure for the identification, evaluation, investigation, and documentation of Out-of-Trend (OOT) results during the testing of raw materials, intermediates, and APIs to detect process variability and ensure product quality.
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To provide a standardized procedure for the safe and effective operation of the UV-Visible Spectrophotometer, including calibration, sample analysis, maintenance, and documentation for use in testing of APIs and related substances.
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To establish a consistent and traceable system for documenting the usage of chromatographic columns used in HPLC analysis to monitor column life, detect performance trends, and ensure reliability of analytical data.
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To define a systematic procedure for the safe, traceable, and environmentally compliant disposal of test samples after completion of Quality Control analysis in the API manufacturing facility.
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To establish a uniform procedure for the preparation, standardization, labeling, usage, and storage of volumetric solutions used for analytical testing in the Quality Control Laboratory of API manufacturing.
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To provide a clear and structured approach for the review of analytical test reports generated in the Quality Control laboratory, ensuring the accuracy, completeness, integrity, and regulatory compliance of data related to API testing.
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To define a structured process for the transfer of validated analytical methods from the R&D or Analytical Development Laboratory (ADL) to the Quality Control (QC) laboratory for routine use in the analysis of raw materials, intermediates, and APIs.
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