Packaging Material Audits

Careful auditing is also essential for packaging material manufacturers. This concerns both primary packaging materials according to EU GMP Part I and ISO 15378 – that is, primary packaging materials for medicinal products such as blisters, tubes or ampoules – as well as secondary packaging materials (according to GMP Part I and ISO 9001) such as folding cartons and other outer packaging.

Primary packaging materials

Primary packaging plays a decisive role in protection against excessive moisture transfer, solvents as well as light, microbiological contamination and reactive gases. It is in close contact with the product and must therefore be controlled extremely precisely.

We take over for you the verification of the manufacturing, storage, transport and testing of these primary packaging materials. Compliance with the ISO 15378:2017 guideline for the manufacturing and control of primary packaging materials is of essential importance for the safety of the product and, ultimately, of the patient. This guideline combines the core requirements of ISO 9001 with the best practices of Good Manufacturing Practice (GMP).

The primary packaging material manufacturers must not only demonstrate that they are able to meet their requirements, but also comply with the legal and international specifications for primary packaging materials in medical products. Our experienced experts conduct audits at primary packaging manufacturers worldwide to ensure that manufacturing, storage, control and transport are in line with the relevant guidelines.

Secondary packaging materials

Secondary packaging serves primarily to protect and organise the individual product units, which facilitates storage and transport. At the same time, it functions as a brand presentation. Among the best-known secondary packaging in the pharmaceutical industry are boxes and pouches.

The suppliers of such packaging must also be qualified and audited, albeit not as frequently as suppliers of APIs or primary packaging. These manufacturers must meet the requirements of ISO 9001 and important specifications of the European Good Manufacturing Practice (GMP) Guideline Part I in their processes. In addition, there are special requirements for the artwork, the tamper evidence or for serialisation.

Our auditors have many years of experience in audits and inspections of primary and secondary packaging material manufacturers. In recent years they have audited some of the largest packaging material manufacturers in Europe. Audits at packaging material manufacturers can be carried out particularly well as shared audits. This gives you access to high-quality and detailed reports at unbeatable prices – yet there is always the option of conducting individual audits at your suppliers.