Table 2.
Causes, types and prevalence of non-compliances.
| Number of samples incompatible with EP requirements | Causes of non-compliances |
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|---|---|---|---|---|---|---|---|---|
| Exceeded the limit of aerobic microorganisms |
Exceeded the amount of fungi |
Exceeded the number of Gram-negative Enterobacteriaceae bacteria CFU/g |
Presence of E. coli |
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| Number of samples | The level of bacteria CFU/g | Number of samples | The level of fungi CFU/g | Number of samples | The level of Gram(−) CFU/g | Number of samples | Presence of E. coli | |
| Non-aqueous preparations for oral use n = 7 | n = 3 | 1.6 × 105 | n = 4 | 6.0 × 102 | – | – | – | – |
| 6.6 × 103 | 5.6 × 102 | |||||||
| 8.2 × 103 | 8.0 × 102 | |||||||
| 3.4 × 103 | ||||||||
| Aqueous preparations for oral use n = 1 | n = 1 | 4.2 × 104 | – | – | – | – | – | – |
| Cutaneous use n = 0 | – | – | – | – | – | – | – | – |
| Vaginal use n = 0 | – | – | – | – | – | – | – | – |
| Oral dosage forms containing raw materials of natural origin, for which antimicrobial pretreatment is not feasible n = 13a | n = 4 | 6.4 × 104 | n = 7 | 4.3 × 103 | n = 3 | >1.0 × 103 | n = 2 | E. coli |
| 3.2 × 105 | 1.4 × 104 | >1.0 × 103 | E. coli | |||||
| 4.3 × 105 | 6.4 × 102 | >1.0 × 104 | ||||||
| 8.4 × 104 | 2.1 × 103 | |||||||
| 3.4 × 103 | ||||||||
| 1.4 × 105 | ||||||||
| 8.0 × 102 | ||||||||
| Herbal medicinal products to which boiling water is added before use n = 3 | n = 2 | 6.1 × 107 | n = 1 | 3.2 × 105 | – | – | – | – |
| 8.5 × 107 | ||||||||
a
In two samples more than one non-compliance were reported.