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Table 1 Descriptions of defects on the samples and supplied documents observed during visual inspections

From: Study on identification, assay and organoleptic quality of veterinary medicines in Ethiopia

Defects Description of defects
1)Injectable drugs solubility problem Failure to form homogenous solution upon rigorous shakings (formation of strong coagulation)
2)Failure to meet expected packaging and labelling standards Labelling information on primary packaging materials such as blisters and sachets manually affixed incorrectly, e.g. manufacturing dates, expiry dates, and batch/lot numbers information and so on
3)The required actual product concentration did not conform to the stated label claim information and quality requirements Labelling of primary packaging materials describes different concentration and quality attributes of same products
4)Improper labelling information The labelling information did not match the expected product content. In addition, labelling information was not well readable and visible
5)Defects in test method and validation documents Incompatible in-house test method and validation document submission for same (a single) product
6)Inspection of certificate of analysis (CoA) that had different assay result specification limits for the same product Same product, from the same company, having different assay result specification limits, with different Certificate of Analysis (CoA)
7)Nonconformance of vial purity/cleanness Visible rust formation on vial stopper (cap seal), the rust particle might enter into the injectable solution when later punctured/pierced and hence jeopardize the proper drug administration/treatment practices
8)Mislabelling of VMPs importers (local agents) names and contact addresses Labelling information on packaging materials did not match drug sample submitter’s (importers/local agent) names and mismatching of contact addresses