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 |