The Ultimate Resource for Pharmaceutical SOPs and Best Practices
To define the procedure for conducting systematic training for production operators and chemists on In-Process Control (IPC) practices relevant to API manufacturing, ensuring understanding and compliance with cGMP requirements.
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To define the procedure for systematic collection, accurate labeling, and proper storage of control samples from each batch of API manufactured, to support future investigations, re-analysis, or stability studies as per regulatory requirements.
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To establish a standard procedure for the selection, placement, operation, and maintenance of thermocouples used to monitor temperature during critical process stages of API manufacturing.
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To establish a standardized procedure for monitoring and controlling hold times for in-process materials during various stages of API manufacturing and to ensure traceable tracking of IPC and QC samples from collection to final disposition.
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To define the procedure for safe, compliant, and documented destruction of In-Process Control (IPC) samples after testing and analysis are complete, ensuring traceability and adherence to regulatory requirements.
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To define a systematic procedure for the correct sampling of viscous and sticky materials in API manufacturing, ensuring representative samples are collected safely and accurately for IPC and quality testing.
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To establish a standard procedure for the use of Process Analytical Technology (PAT) tools for real-time, online monitoring of critical process parameters and quality attributes during API manufacturing to ensure consistency, compliance, and process understanding.
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To establish a standardized method for using handheld pH and conductivity meters to perform in-process checks during API manufacturing. This ensures consistency in monitoring critical quality attributes and compliance with GMP.
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To establish a standardized procedure for reviewing and verifying the documentation of In-Process Control (IPC) checks recorded during API manufacturing, ensuring data accuracy, compliance with cGMP, and traceability for quality assurance and audits.
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To define a standardized procedure for trending In-Process Control (IPC) test results and related deviations in API manufacturing to monitor process stability, detect patterns, and facilitate continual improvement and CAPA (Corrective and Preventive Action) implementation.
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