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 processes. The concept allows a company to track all materials, steps, and test results that belong to the overall lot, even if the production occurred in portions or across shifts. The Gesamtcharge is typically assigned a unique identifier in the batch records.

In the pharmaceutical industry, the Gesamtcharge aligns with the concept of a lot or batch intended for release. It encompasses the complete set of materials, manufacturing steps, in-process controls, and final testing that define a single, regulatable unit. This enables traceability from raw materials to finished product and supports regulatory requirements for quality assurance, investigations, and recalls.

Documentation and regulatory context are central to the Gesamtcharge. Batch records, material certificates, and test results are linked to the Gesamtcharge identifier. In the event of deviations or quality issues, investigations are traced back through the Gesamtcharge to identify root causes and implement corrective actions. Yield calculations and cost accounting are often performed at the level of the Gesamtcharge.

See also: batch, lot, traceability, quality assurance, GMP.