Table 1 Descriptions of the seven main defect categories

I. Contamination

‘The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or onto a starting material or intermediate during production, sampling, packaging or repackaging, storage or transport’ [28].

II. Stability defect

‘Stability is the ability of a pharmaceutical product to retain its chemical, physical, microbiological and biopharmaceutical properties within specified limits throughout its shelf-life’ [29]. Therefore, if this criterion was not met, the case was considered as a stability defect.

III. Active pharmaceutical ingredient (API) defect

‘Any substance or mixture of substances intended to be used in the manufacture of a pharmaceutical dosage form, to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body’ [28]. API should be within the specified limits of the assay (pharmacopoeial standard). Therefore, if this criterion was not met, the case was considered as API defect.

IV. Packaging and labelling defects

‘Any material, including printed material, employed in the packaging of a pharmaceutical, but excluding any outer packaging used for transportation or shipment. Packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product’ [28]. Defects related to labelling and packaging were included in this category.

V. Variation in physical properties such as weight and volume

Failure to comply with pharmacopoeial specifications stated under uniformity of weight or volume [30] were considered in this category.

VI. Adverse events reported

Cluster of adverse events reported were considered in this category.

VII. Unclassified

Cases which could not be included to any of the above categories were considered in this category.