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13 and to the limits specified in USP <1111> and EP 5
and purity
Drug products that have been subjected to improper storage conditions shall not be salvaged
any person acting as a wholesale distributor has to hold a wholesale distribution authorisation
3.2 - Buildings and Facilities - Laboratory inspection 13 and to the limitsNormally, 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
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