The layout of the areas should be in accordance with sequence of production where possible. All areas should be of an appropriate cleanliness level. There should be procedures and records for the cleaning.

There should be adequate work and in-process storage space and orderly and logical positioning of equipment is essential to minimize the risk of contamination, mix-ups and missing production steps.

Specially designed areas for packaging are recommended and care should be taken to prevent contamination and cross-contamination also during packaging (primary packaging - where product and materials are exposed to the environment). The lay out should be such to avoid mix-ups and cross-contamination.