FDA regulation establishing current good manufacturing practice (CGMP) for finished pharmaceuticals. Its building, sanitation and storage requirements shape how pallets are used in drug manufacturing.
Detailed Definition
21 CFR Part 211 is titled Current Good Manufacturing Practice for Finished Pharmaceuticals. It covers organization and personnel, buildings and facilities, equipment, control of components and drug product containers and closures, production and process controls, packaging and labeling, holding and distribution, laboratory controls, and records. Pallets are not regulated as such, but the rule requires certain containers of components and closures to be stored off the floor and spaced to allow cleaning and inspection, and buildings must be kept clean and free of pests.
Why pallet choice matters in drug plants
Part 211 requires that buildings and equipment support cleaning and prevent contamination and mix-ups. Wood pallets can shed fibers and splinters, absorb moisture and harbor mold or insects, so many pharmaceutical sites restrict wood pallets to warehouse areas and use plastic or metal pallets in cleanrooms and controlled areas. Some sites transfer goods to internal pallets at a receiving airlock.
These are company decisions documented in procedures, not specific rule text. Auditors look for a consistent, justified approach.
What to put in a pallet procedure
- approved pallet types for each area and grade of room
- inspection and cleaning steps, and how often
- quarantine and status labeling so pallets do not cause product mix-ups
- pest control around pallet storage
- handling of ISPM 15 export pallets for international shipments
Warehouse temperature and humidity control, if needed for the product, is covered under holding and distribution, and good distribution practice guidance adds more detail.
Related rules and guidance
Part 211 works alongside 21 CFR Part 210, which sets definitions and general CGMP provisions for drugs, and 21 CFR Part 11 for electronic records. Active ingredient makers often follow ICH Q7. None of these certify pallets, so the site's own procedures define what is acceptable.
Related Glossary Terms
Frequently Asked Questions
Does 21 CFR Part 211 ban wood pallets?
No. The rule does not ban any pallet material. It requires facilities and storage practices that prevent contamination and allow cleaning and inspection. Many drug manufacturers keep wood pallets out of production and cleanroom areas as a matter of their own procedures, because wood is hard to clean and can carry pests or mold. Warehouses often still use wood.
What does storing components off the floor mean for pallets?
Part 211 requires bags or boxes of components, drug product containers and closures to be stored off the floor and suitably spaced for cleaning and inspection. Pallets and racks are the usual way to meet this. Keeping space between pallet rows and walls makes cleaning and pest monitoring possible and is a common audit point.