Can you sample containers, closures, and packaging materials for receipt examination directly in the warehouse?
Sampling in the warehouse
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The short answer is – Yes.
The FDA believes that sampling in a typical drug manufacturing facility warehouse would not represent a risk to the container or closure or affect the integrity of the sample results. But whether the act of collecting a sample in the warehouse violates the CGMP requirement that containers “be opened, sampled, and sealed in a manner designed to prevent contamination of their contents…” will depend on the purported quality characteristics of the material under sample and the warehouse environment.
For containers or closures purporting to be sterile or dehydrogenated, sampling should be under conditions equivalent to the purported quality of the material: a warehouse environment would not suffice (see 21 CFR 211.94 and 211.113(b)). This is to preserve the fitness for the use of the remaining containers or closures and ensure sample integrity if they are to be examined for microbial contamination. At a minimum, any sampling should be performed to limit exposure to the environment during and after the time samples are removed (i.e., wiping outside surfaces, limiting the time that the original package is open, and properly resealing the original package). Well-written and followed procedures are the critical elements.
Note that the CGMPs at 21 CFR 211.84 permit a manufacturer to release for use a shipment of containers or closures based on the supplier’s certificate of analysis and visual identification of the containers or closures. Once a supplier’s reliability has been established by validating their test results, a manufacturer could perform the visual examination entirely in the warehouse.