Contamination in medicines: how to monitor the safety of your processes?

Contamination in medicines: how to monitor the safety of your processes?

Contamination in medicines: how to monitor the safety of your processes?

Contaminações em medicamentos: como monitorar a segurança dos seus processos?

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:

Tabela

Programs

Tests

Accreditation
Sterile Pharmaceutical
Products I

Sterility testing in pharmaceutical raw materials, injectable medicines, ophthalmic solutions, and healthcare products.

 Ensaio de Proficiência
Non-Sterile Pharmaceutical
Products I

Total aerobic mesophilic microorganism count

Search for:

- Fecal Coliforms

- Bile-tolerant Gram-negative bacteria in oral and topical medicines

 Ensaio de Proficiência

Controllab also offers other programs that support laboratory routines and reinforce the reliability of results. These are:

Tabela

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

 		Ensaio de Proficiência
Non-Sterile Pharmaceutical
Products II

Mold and yeast count

Search for:

- Candida albicans

- Clostridia

- Sulfite-reducing Clostridia

- Clostridium perfringens

- Staphylococcus aureus

 Ensaio de Proficiência

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.

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PRM 0009

Certified Reference Material Producer

Accredited by Coordenação-Geral de Acreditação do Inmetro

Controllab has been accredited as a Certified Reference Material (CRM) Producer since 2016 by Cgcre, under number PMR 0009. The conformity assessment is carried out in accordance with the requirements established in ABNT NBR ISO 17034 and Inmetro standards, ensuring competence for the production of CRMs, as defined in the Scope of Accreditation.

This accreditation attests to Controllab’s technical competence in producing CRMs according to international requirements and enables it to be recognized in other countries, under mutual recognition agreements, thereby reducing technical barriers between Brazil and other countries across continents.

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Materiais de Referência Certificados - PMR 0009 - ABNT NBR ISO 17034-Controllab
Cgcre is signatory to the Mutual Recognition Arrangements of the International Laboratory Accreditation Cooperation (ILAC) and Interamerican Accreditation Cooperation (IAAC).

CAL 0214

Calibration Laboratory

Accredited by Coordenação-Geral de Acreditação do Inmetro

In December 2002, the Calibration Laboratory was accredited by Cgcre. With this recognition, it became part of the Brazilian network of accredited laboratories, under number 214. Since then, it has been periodically evaluated for the maintenance and/or extension of its accreditation.

The Inmetro seal attests to Controllab’s technical competence, credibility, and operational capability for calibration services, in accordance with the requirements of ABNT NBR ISO/IEC 17025.

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Calibração de Instrumentos - CAL 0214 - ABNT NBR ISO/IEC 17025 - Controllab
Cgcre is signatory to the Mutual Recognition Arrangements of the International Laboratory Accreditation Cooperation (ILAC) and Interamerican Accreditation Cooperation (IAAC).

PEP 0003

Proficiency Test Provider

Accredited by Coordenação-Geral de Acreditação do Inmetro

In September 2011, Controllab was accredited by Cgcre as a proficiency test provider, under nº PEP0003. Initially as part of a pilot project by Inmetro, this accreditation was based on ILAC G13: 2007 and included several clinical and hemotherapy tests. In the periodic evaluations of this accreditation, new segments and tests are included and the evaluation is now conducted according to ABNT NBR ISO/IEC 17043.

This accreditation attests to Controllab’s technical competence to develop and conduct proficiency tests in accordance with international requirements and enables it to be recognized in other countries, in accordance with mutual recognition agreements signed by Brazil in Mercosur, the Americas and Europe.

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PEP 0003 - ABNT NBR ISO-IEC 17043 - Controllab

Cgcre is signatory to the Mutual Recognition Arrangements of the International Laboratory Accreditation Cooperation (ILAC) and Interamerican Accreditation Cooperation (IAAC).