4/5 October 2023
The German Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, ZLG) has published a newly prepared document entitled "Inspektion der Eignung von Transportprozessen" (Inspection of the Suitability of Transport Processes). The PDF file with the identifier AiM 07123201 is publicly available for download in German language on the ZLG Homepage (Quality Manual, chapter 7).
The document, which is applicable to GMP and GDP areas, is primarily aimed at the personnel of the competent authorities. It is a so-called Aide mémoire (AiM), a catalogue of standards, questions and recommendations, which serves to harmonise the preparation, execution and follow-up of an inspection.
The transport of medicinal products and veterinary medicinal products as well as active pharmaceutical ingredients (APIs) are considered. Therefore, the contents are not only of interest to inspectors, but also to pharmaceutical manufacturers and wholesalers.
The twelve-page paper starts with a description of the purpose and an overview with definitions, abbreviations and references to core documents.
The main chapters deal with the following aspects:
Additional literature is referred to at the end of the document.