Production and process controls under Subpart F, and packaging and labeling controls under Subpart G.
This module covers Subpart F production and process controls, written procedures, component charge-in, yield calculation, equipment identification, microbiological contamination control and reprocessing, alongside Subpart G packaging and labeling requirements: labeling issuance, control and reconciliation, packaging operations, tamper-evident packaging and drug product inspection and expiration dating.
Labeling mix-ups and yield discrepancies are two of the most consequential errors a production floor can make, since one leads directly to patient safety risk and the other is often the first sign that something in the process went wrong unnoticed.
Completion certificate, PDF slide download, and access to the complete GMP course library from day one.
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