Controllab’s Proficiency Testing programs are strategic allies for evaluating laboratory routines and reinforcing the reliability of results.
Pharmaceutical products require strict quality controls to ensure the safety and health of the population. A recent incident in Argentina highlights the seriousness of this responsibility: contaminated fentanyl batches caused severe infections by Klebsiella pneumoniae and Ralstonia pickettii, some strains resistant to multiple antibiotics, resulting in fatal clinical outcomes for dozens of patients.
Cases like this underscore the importance of practices that ensure the reliability of analytical results and, consequently, the quality of products made available on the market. In this context, Controllab, a leader in laboratory quality control in Latin America, offers Proficiency Testing (PT) programs designed for laboratories working with Sterile and Non-Sterile Pharmaceutical Products.
These programs evaluate analytical performance using control samples recognized by the Coordenação-Geral de Acreditação do Inmetro (PEP 0003), Brazil’s accreditation authority. Comparing results with other participants and analyzing the outcomes allows laboratories to detect and correct analytical deviations, improve process efficiency and safety, and demonstrate regulatory and normative compliance.
The programs include the following tests:
|
Programs |
Tests |
Accreditation |
| Sterile Pharmaceutical Products I |
Sterility testing in pharmaceutical raw materials, injectable medicines, ophthalmic solutions, and healthcare products. |
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| Non-Sterile Pharmaceutical Products I |
Total aerobic mesophilic microorganism count Search for: - Fecal Coliforms - Bile-tolerant Gram-negative bacteria in oral and topical medicines |
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Controllab also offers other programs that support laboratory routines and reinforce the reliability of results. These are:
|
Programs |
Tests |
Accreditation |
| Sterile Pharmaceutical Products II |
Mold and yeast (fungi) count Sterile II (Detection /1 mL) Search for: - Clostridia - Sulfite-reducing Clostridia - Clostridium perfringens - Staphylococcus aureus |
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| Non-Sterile Pharmaceutical Products II |
Mold and yeast count Search for: - Candida albicans - Clostridia - Sulfite-reducing Clostridia - Clostridium perfringens - Staphylococcus aureus |
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By participating in the Proficiency Testing program, laboratories strengthen the traceability and reliability of their analyses, reduce health risks, and contribute directly to the protection of public health.
To learn more about these and other programs that support analytical routines, access the online catalog.
