Table 1.
Type of quality deviations.
| Type of deviation | Description |
|---|---|
| Package anatomical problems | Deviations related to the shape of the product and package. Since it is an integral part of the product, it also includes the technical problems found during product handling, difficulty in opening (which may cause injury to the manipulator) and type of primary package incompatible with the characteristic of the medicament (as colorless glass ampoules for medicaments subject to photolysis) |
| Breaks/splits/leaks | Breaks, splits, holes and microholes in vials, ampoules, and sealed flask ampoules. It can cause leaks bringing on environmental and individual contamination with the substance |
| Lack of identification – information | Lack of identification, such as label and/or fundamental information that determine the best use of the product, such as concentration, dosage, name and administration of the medicine |
| Poor quality of information | Information presented on the package, labels and instructions that generate some kind of confusion or difficulty in reading. This includes package or commercial names similar to another product, difficulty in reading information due to poor print quality or small letters and the presence of more than one lot number and/or validity |
| Lack of the product – lower volume | Lack of the product in a sealed primary package and/or the absence of primary package in a sealed secondary package and/or volume below that declared in the label |
| Foreign body – dirtiness | The presence of a foreign body in the product (undissolved particulate material contaminants such as dust, fabric fibers, glass fragments, leachate material in covers/plastic and any other material that may pass into the product during manufacturing or develop during storage) and dirtiness in the primary package |
| Organoleptic changes | Color changes, odor, taste, limpidity (related to turbidity, and does not include particulate material), viscosity and original consistency of the product |
| Physicochemical changes of solids products | Quality deviations that compromise the physical and chemical characteristics such as hardness, friability, thickness and coating of tablets, capsules oscillation and fissures and difficulties in rebuilding powder into solution/injectable suspension |
| Physicochemical modifications of liquid and semisolid products | Crystallization, precipitation, incomplete redistribution of the dispersed phase in the dispersion environment (sedimentation, flocculation and aggregation of suspended particles) and emulsion coalescence |