3.2 - Buildings and Facilities - Laboratory inspection and purity

and purity

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

to ensure that it functions in accordance with its intended use

or every manufactured batch

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

3.2 - Buildings and Facilities - Laboratory inspection and purityNormally, 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