Do you have separate or defined areas to prevent contamination or mix-ups of materials?

designated areas to prevent contamination

According to the Code of Federal Regulations (21 CFR 211.42 Design and Construction Features), any building or buildings used in the manufacture, process, packing or holding of a drug product:

  • Should be of suitable size, construction, and location,
  • Should have adequate space for the orderly placement of materials to prevent mix-ups between different materials. 
  • The flow through the building(s) should be designed to prevent contamination.

A company recently received the following observation:

…. Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the storage of drug products after release.


a.         During our walkthrough of the Raw Material Storage Room, we observed a shelf designated as “Location …” with containers of … (Batch …) stored near containers of various cosmetic inactive ingredients, including …  You indicated this shelf was specifically for drug raw materials.

b.         CAPA #…, was for the mix-up of approved drug and cosmetic raw materials with approved drug in-process bulk and finished products in the warehouse. Despite the CAPA being completed, we observed during our walkthrough of Warehouse …, the presence of OTC drug raw materials, in-process bulk, and finished products being stored outside their designated locations on shelves and adjacent to cosmetic raw materials and finished products.

In addition, the flow and storage of quarantined and released drug components, in-process bulk, and finished product, including labels, bottles, and packaging, are not designed to prevent contamination and mix-ups. For example:

a.         In Warehouse … raw materials just received were held right next to finished product awaiting shipment, and quarantined in-process bulk was stored next to released cosmetic inactive ingredients. Released drug raw materials were stored in both Warehouse … and the Raw Material Storage Room.

b.         In Warehouse … quarantined in-process bulk was also stored here, which was next to open boxes of finished product, .., drug and cosmetic product labels and packaging were stored in an unsecure fashion, with no access control.

As such, the lack of segregation and defined areas introduces the potential for contamination, mix-ups, and human error.

For more information on how to establish and maintain Facilities and Equipment refer to the following FDA presentation Facilities and Equipment: cGMP Requirements.

To view more observations pertaining to facility design, refer to the following GMP Trends® Issues: 1098, 1069, 1040, 1027.

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