FDA Expectations regarding Facilities for Sampling Packaging Materials

In the questions and answers on current discussion points regarding the interpretation of certain CGMP requirements from FDA's point of view, one question dealt with the sampling of packaging materials:

Can the sampling of closures and packaging materials within the framework of receipt examination be performed in the warehouse?

Anthony Charity, CDER, FDA, gives the answer:

Yes! In general one starts from the assumption that sampling in the typical warehouse of a manufacturer of medicinal products does not present a risk for the packaging materials or impact the integrity of the sampling test results.

However, if sampling in a warehouse fulfils the fundamental CGMP requirement under 21 CFR 211.84(c)(2) that opening, sampling and sealing the containers must be done in a way as to prevent contamination of the content depends on the required quality characteristics of the material and on the warehouse environment. For sterile or depyrogenated materials, sampling in the warehouse itself is certainly not allowed.

Charity also points out expressly that the CGMPs at 211.84 permit a pharmaceutical company to release a shipment of packaging material on the basis of the certificate of analysis and a visual evaluation of the delivered batch. So, if the reliability of the supplier has been checked and determined by means of "validating" the test results, the visual examination can be performed entirely in the warehouse.

The complete document and the text can be found here.  

Dr Günter Brendelberger
On behalf of the European Compliance Academy (ECA)


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