Table 2.
Defects by categories and subcategories
| Main categories (n, %) | Subcategories | |
|---|---|---|
| I | Contamination (n = 59,36.2) | Colour variations, impurities, outside standards (n = 49) |
| Lack of sterility (n = 7) | ||
| Microbiological contamination (n = 3) | ||
| II | Stability defects (n = 41, 25.2) |
Unspecified stability failure (n = 33) Failure in dissolution test (n = 8) |
| III | Active pharmaceutical ingredient (API) defects (n = 26, 15.9) | API out of specification (either more or less) (n = 26) |
| IV | Variation in physical properties such as weight and volume (n = 4, 2.4) |
Weight variation (n = 3) Volume variation in single dose parenteral preparation (n = 1) |
| V | Packaging and labelling defects (n = 27, 16.6) |
Failure in container closure system functionality (n = 6) Packaging in a wrong carton (n = 1) Manufacturer's information missing (n = 4) Contain a lesser number of tablets than stated (n = 1) Failure to comply with the description as per the manufacturer’s specifications (n = 7) Labelling errors (n = 8) |
| VI | Adverse events reported (n = 1, 0.6) | A cluster of adverse drug reaction (ADR) events reported (n = 1) |
| VII | Unclassified (n = 5, 3.0) | Data not adequate to assess (n = 5) |
Total number of defects reported (N = 163)