3.2 - Buildings and Facilities - Laboratory inspection Drug products that have been

Drug products that have been subjected to improper storage conditions shall not be salvaged

to ensure uniformity in every finished batch and that it meets its specification

There should be adequate suitable storage space for samples and records

from which the expiry date can be calculated

13 and to the limits specified in USP <1111> and EP 5

3.2 - Buildings and Facilities - Laboratory inspection Drug products that have beenNormally, Quality Control laboratories should be separated from production areas and should be designed to suit the operations to be carried out in them. Sufficient space should be given to avoid mix ups and cross contamination. There should be adequate suitable storage space for samples and records