SOPs for API Manufacturing V 2.0

To define a uniform procedure for the systematic review and archival of analytical data, ensuring compliance with regulatory standards, traceability, and data integrity in the API manufacturing Quality Control Laboratory.
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To establish a detailed procedure for sampling, testing, reviewing, and reporting of API intermediates and final batch samples to ensure conformance with approved specifications and regulatory compliance before batch release.
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To establish a standardized procedure for managing incidental laboratory spills involving chemicals, solvents, reagents, or samples in the Quality Control laboratories of API manufacturing, ensuring personnel safety, containment, and proper documentation.
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To establish a scientifically sound and regulatory-compliant procedure for initiating reanalysis of samples that have yielded out-of-specification (OOS), out-of-trend (OOT), or anomalous results in the QC laboratory of API manufacturing.
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To provide a standardized and regulatory-compliant procedure for the review of chromatograms and peak integration for High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), and other applicable analytical methods used in API manufacturing.
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To provide detailed instructions for the proper and consistent use of Fourier Transform Infrared (FTIR) Spectrometer for analysis of raw materials, intermediates, and APIs in the Quality Control laboratory of the API manufacturing unit.
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To establish a standardized procedure for the calibration, maintenance, and usage of pH meters in the Quality Control (QC) laboratory to ensure accurate and reliable pH measurements in API manufacturing.
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To define the procedure for proper collection, storage, handling, and periodic testing of control samples of raw materials, intermediates, and APIs in accordance with GMP requirements.
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To define the procedure for systematic verification of data entries in the Laboratory Information Management System (LIMS) to ensure accuracy, completeness, and compliance with cGMP and data integrity principles in API manufacturing.
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The purpose of this SOP is to establish a consistent and traceable system for assigning laboratory numbers to samples and to define a structured process for tracking the movement and status of samples received in the Quality Control (QC) department of the API manufacturing facility.
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