Packaging material audits
GxP audits worldwide
Careful auditing is also essential for packaging manufacturers.
This applies to both primary packaging in accordance with EU GMP Part I and ISO 15378 – i.e. primary packaging for medicinal products such as blisters, tubes or ampoules – and secondary packaging (in accordance with GMP Part I and ISO 9001) such as folding cartons and other outer packaging.
Primary packaging materials
Primary packaging plays a crucial role in protecting against excessive moisture transfer, solvents and light, microbiological contamination and reactive gases.
They are in close contact with the product and must therefore be controlled extremely precisely.
We take over the inspection of the production, storage, transportation and testing of this primary packaging for you.
Compliance with ISO 15378:2017 Guideline for the manufacture and control of primary packaging is essential for the safety of the product and ultimately the patient.
This guideline combines the core requirements of ISO 9001 with the best practices of Good Manufacturing Practice (GMP).
Primary packaging manufacturers must not only prove that they can meet their requirements, but also that they comply with the legal and international requirements for primary packaging in medical products.
Our experienced experts conduct audits at primary packaging manufacturers worldwide to ensure that production, storage, control and transportation are in line with the relevant guidelines.
Secondary packaging
Secondary packaging primarily serves to protect and organize the individual product units, which facilitates storage and transport.
At the same time, they act as a brand image.
The best-known secondary packaging in the pharmaceutical industry includes boxes and pouches.
Suppliers of such packaging must also be qualified and audited, although not as frequently as suppliers of APIs or primary packaging.
These manufacturers must fulfill 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 art work, tamper evidence and serialization.
Our auditors have many years of experience in audits and inspections of primary and secondary packaging manufacturers.
In recent years, they have audited some of the largest packaging manufacturers in Europe.
Through our internal qualification process, we ensure that our auditors are optimally prepared and qualified for each audit ordered.
The CVs of our auditors are part of our comprehensive audit documentation and can be viewed after ordering the audit in our user-friendly web app after ordering the audit.
Audits at packaging manufacturers can be carried out particularly well as shared audits.
This gives you access to high quality and detailed reports at unbeatable prices!
Nevertheless, there is always the option of carrying out individual audits at your suppliers.
Please contact us at audit@heacon.de or visit pharma-audit.appto order your next packaging audit.
