The Ultimate Resource for Pharmaceutical SOPs and Best Practices
To define the procedure for the identification, documentation, investigation, and resolution of Out of Trend (OOT) or Out of Specification (OOS) in-process control (IPC) results in API manufacturing, ensuring consistent process control and compliance with GMP.
Click to read the full article.
To define a systematic procedure for Quality Assurance (QA) to cross-verify In-Process Control (IPC) data documented during the manufacturing of Active Pharmaceutical Ingredients (APIs), ensuring integrity, traceability, and adherence to GMP.
Click to read the full article.
To establish a standardized procedure for the use of Thin Layer Chromatography (TLC) in determining the completion of chemical reactions during the manufacturing of Active Pharmaceutical Ingredients (APIs).
Click to read the full article.
To define a standardized procedure for conducting moisture content analysis of intermediate materials using an infrared (IR) moisture balance during the manufacturing of Active Pharmaceutical Ingredients (APIs).
Click to read the full article.
To define the standard procedure for performing visual inspection of semi-solid intermediates during API manufacturing for monitoring appearance, color, uniformity, and identification of foreign particles or physical non-conformities.
Click to read the full article.
To define a safe, controlled, and GMP-compliant procedure for the sampling of highly potent and/or toxic compounds during API manufacturing using containment equipment and appropriate personal protective equipment (PPE).
Click to read the full article.
To define the procedure for the collection, labeling, handling, storage, and retention of In-Process Control (IPC) samples taken during API manufacturing to ensure traceability and availability for re-testing or investigation, if required.
Click to read the full article.
To define a standardized procedure for performing clarity testing of filtrates collected during filtration steps in API manufacturing, ensuring absence of particulate matter and confirming filtration integrity.
Click to read the full article.
To define a systematic procedure for monitoring and confirming the end-point of crystallization during the manufacturing of Active Pharmaceutical Ingredients (APIs), ensuring consistency, purity, and yield of the final product.
Click to read the full article.
To define a standard and GMP-compliant format for documenting In-Process Control (IPC) observations, results, and decisions in designated IPC logbooks during API manufacturing processes.
Click to read the full article.