Ask Our Experts – Validity period of FDA Certificates of Conformity?

A manufacturer of pharmaceutical production facilities and containers must provide evidence of FDA conformity of materials in contact with the product, especially sealing materials. This repeatedly leads to discussions within the company about the validity period of corresponding supplier certificates. Is a certificate simply valid until a new certificate is issued because, for example, the material composition has changed? Is a 10-year-old certificate of conformity still valid?

On the the FDA’s website, the reference was found that processes must be reviewed in 3-year intervals. Whether this also applies to corresponding evidence could not be answered by anyone until now.

Short and sweet:
Do FDA Certificates of Conformity confirming that the product is safe within the meaning of FDA 21 CFR 177.2600 ("Rubber articles intended for repeated use") have a maximum validity period?

We have passed this interesting question on to our team of experts and received two statements which will certainly provide food for thought for further decision-making within the company.

Richard Denk, our expert in the field of Hygienic Design and Containment, is of the opinion that he would not only doubt a 10-year-old document, but would directly reject it. He writes about it:

"We have always requested the certificates from the manufacturer per single shipment and have also referred to the manufacturing batch, as the composition or even the supplier of the components can change. It is rather unlikely that a manufacturing batch will last 10 years. There is also an expiry date for plastics, such as for gloves on the isolator. “

And Ruven Brandes, Head of Technical and Compliance Support technical QA, explains in detail:

"Although the jurisdiction of the FDA is limited to the United States, its regulations are globally recognized as auditing standards - unfortunately. Under the Codes of Federal Regulations (CFRs), the FDA publishes a list of materials and chemicals that are approved for food contact.

Paragraphs A to D of FDA code CFR 21.177.2600 describe the relevant regulations for "rubber articles for repeated use". They list the ingredients and all quantitative restrictions that may be used in rubber compounds for moulded products for repeated use in all stages of production, preparation and transportation of food.

Paragraphs E and F of the FDA code CFR 21.177.2600 also define the limits for extractable products when the FDA rubber seal is used in contact with aqueous or fatty foods. The regulation sets extraction test limits in water and n-hexane. It is important to note that this claim must be supported by appropriate documentation, such as FDA approval of a manufacturer, for an FDA rubber material to be considered to meet these requirements.

The FDA does not grant approval for products according to CFR 21.177.2600. Proof of conformity is the responsibility of the manufacturer of the finished FDA-compliant rubber product by publishing an FDA certificate. “

He further notes that even if a component is made of a rubber material that is food grade according to FDA, it is not automatically technically suitable for the intended application. The FDA does not test the different plastics. Neither components nor semi-finished products are tested. Rather, the materials used in the applications must comply with the recommendations and requirements of the FDA.

As a consequence, no certificates or test certificates can be issued, but only notifications confirming the compliance of the delivered plastics with the corresponding CFR titles or the FCN. An FDA conformity assessment is therefore not a "concrete" statement. It is the responsibility of the manufacturer to keep the "conformity" constantly up to date - without this being constantly checked! Only when the manufacturer exports to the USA does he have to provide corresponding evidence on a regular basis.

A seal used in the European Union must comply with European laws. Even though FDA and European regulations have a lot in common, the Regulation EU 10/2011 sets much stricter requirements for migration values. In most cases, a seal complies with both American and European laws. In the EU, conformity must/should be proven every three years and presented on request. If a supplier "only" refers to the FDA, this is extremely critical and MUST be reconfirmed for each delivery and batch. "Good" companies deliver these certificates of their own accord with every delivery!

Editorial tip:

• Here you can find the requirements of the REGULATION (EU) No.10/2011:
  https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:012:0001:0089:EN:PDF
• Here you can go directly to 21 CFR 177, PART 177 INDIRECT FOOD ADDITIVES: POLYMERS:
  https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=177.2600

As a customer of GMP Compliance Adviser you will find further information in the following chapters:

• Chapter 4.B Materials
• Chapter 17.C Suppliers

LOGFILE Feature 24/2020 – Ask Our Experts – Validity period of FDA Certificates of Conformity?

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