New ZLG Document on Transport Verification Published

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.

Content of the new Document

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:

• Procedure for transport verification: The procedure for transport verification, including the preceding steps, is described using an exemplary flow chart. The definition of the transport process and the controls as well as the topics of risk analysis, assessment and control are addressed.
• Transport verification: The relevant points to be verified on the basis of the documentation are listed.
• Transport verification vs. validation: The difference between the two terms is pointed out, and it is highlighted that due to the variability of transport processes, transport validation is often only achievable for sub-processes.
• Ensuring the quality of medicines, veterinary medicines and APIs throughout the supply chain.

Additional literature is referred to at the end of the document.