Incoming goods control

All materials required in the production area of INM-5 for the manufacture and/or quality control of radioactive medicinal products are subject to an incoming goods inspection as part of a strictly regulated procurement process for raw materials, auxiliary materials and services. This initially involves checking that the information on the delivery bill matches the information on the labels on the supplier's containers. The containers are then checked for anomalies, damage and the integrity of the closures. If safety data sheets, certificates of analysis (CoA) or other certificates are available, these are also checked for completeness and accuracy. Each material is then given a unique material number, which is defined on an ongoing basis during the development of manufacturing and test specifications.

In order to be able to clearly assign a material or product to specific batches or production processes during its life cycle in the warehouse and production area as well as after dispatch, each item is also assigned an internal batch number after delivery, which is made up of the item's abbreviation, the analysis date (year, month, day) and the numbering of the individual bottles. The containers are then labeled manually when the material or products are received. The material is only released for use in radiopharmaceutical production by one of the qualified persons once all tests have been carried out and all necessary certificates are available.