Discussions about Material Certificates

The question around the material certificates needed for metallic products to comply with GMP documentation has long existed. Still, this topic is continuously being discussed and can be found in respective specialised forums. 

According to DIN-EN 10204, the following applies:

  • Certificate 2.1 - confirmation from the manufacturer that the product supplied complies with the requirements of the order.
  • Certificate 2.2 - Same as 2.1 with additional indication of the test results based on non-specific inspection and testing (the manufacturer determines the tests himself).
  • Test certificate 3.1 - The tests are determined in advance. The performance of the tests is fixed in technical rules or in the specification/order. A person independent from the manufacture is in charge of the test report. A link to each component with 3.1 certificates to the respective batch/melt is available.

The frequent question arising is whether a 2.2 or a 3.1 certificate is needed, as 3.1 certificates are more expensive. In the end, the answer is always "it depends". For sure is that no GMP guideline requires the one or the other certificate. It is up to the pharmaceutical user to make a risk-based decision. Different risks must be taken into consideration. The first question is: where will the component be used? Will it come into direct contact with the product? Besides, the question of the origin of the component has to be considered: how well do I know the supplier? Has he already been audited? Does he have experience or references from the pharmaceutical industry? A further risk factor concerns the plant or its construction itself and more precisely the risk of mix-ups. Does the construction take place at a well-known manufacturer in his well organised factory? Or is it a tubing that has to be installed on-site, while other tasks are being carried out in parallel? In such a case, as the risk of mix-ups would be greater, 3.1 certificates may be required. 

Yet, the trend is to move away from the 3.1 certificates - in the cases of surfaces which don't come into contact with the product - although in the meantime they have been more and more required. To some extent 2.2 certificates are ordered and, for example, tube components are spot checked on-site by the manufacturer or by a third person. Until now, the theoretical question on a material certificate for welding electrodes has arisen. Let's hope that this will remain a theoretical request.

Dr Robert Eicher
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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