Gesamtcharge
Gesamtcharge is a term used in manufacturing and quality management to refer to the complete production batch or the aggregated set of sub-batches that are combined into a single final lot. It serves as a basis for traceability, release decisions, and quality control within a production campaign.
In practice, a Gesamtcharge may consist of multiple sub-batches produced in one or more runs, lines, or
In the pharmaceutical industry, the Gesamtcharge aligns with the concept of a lot or batch intended for
Documentation and regulatory context are central to the Gesamtcharge. Batch records, material certificates, and test results