🇵🇱 NARODOWY INSTYTUT LEKÓW PL
MicrobiologyPharma & cosmetics
NARODOWY INSTYTUT LEKÓW is a laboratory accredited by PCA under number AB 774 (Warszawa, Poland). Its accreditation scope covers 17 test methods in the following areas: Microbiology, Pharma & cosmetics. Test objects include: Bacterial strains, Other products: medicinal products, medical devices, biocidal products, Medical devices, Pharmaceutical products, Crystalline substances. Most frequently used techniques: Methods: direct plating, filtration through membrane filters, Culture method; Biochemical method; Serological method; Microscopic…, Disc diffusion method.
At a glance
- Accreditation number: PCA AB 774
- Methods in scope: 17
- Types of test objects: 8
- Techniques used: 12
- City: Warszawa, Poland
- Accreditation number
- AB 774
- Accreditation body
- PCA
- Address
- ul. Chełmska 30/34, 00-725 Warszawa
- City
- Warszawa, Poland
What this laboratory tests (8)
- Bacterial strains — 6 methods
- Other products: medicinal products, medical devices, biocidal products — 4 methods
- Medical devices, Pharmaceutical products — 2 methods
- Crystalline substances — 1 method
- Medical devices — 1 method
- Medicinal products, Medical devices containing active substances, Food supplements, foodstuffs for particular nutritional uses, Household chemical products, Organic substances/compounds — 1 method
- Medicinal products, organic substances/compounds: - synthetic; - of natural origin; - biopharmaceuticals — 1 method
- Other products: medicinal products/ antibiotics and chemotherapeutics — 1 method
Analytical techniques used (12)
- Methods: direct plating, filtration through membrane filters — 3 methods
- Culture method; Biochemical method; Serological method; Microscopic method; Mass spectrometry method — 2 methods
- Disc diffusion method — 2 methods
- Biochemical method; Culture method — 1 method
- Gel-clot technique; Method A: Limit test; Method B: Semi-quantitative test — 1 method
- Gradient strip method; Broth microdilution method — 1 method
- High-performance liquid chromatography with tandem mass spectrometry (HPLC-MS/MS) — 1 method
- Method: diffusion (cylinder-plate) — 1 method
- Method: filtration through membrane filters — 1 method
- Method: on extracts, in direct contact, agar diffusion, filter diffusion — 1 method
- Nuclear magnetic resonance spectrometry method ( NMR) — 1 method
- X-ray powder diffraction method (XRPD) — 1 method
Laboratory sections (5)
- Department of Epidemiology and Clinical Microbiology National Reference Centre for Antimicrobial Susceptibility (KORLD) — 5 methods
- Department of Pharmaceutical Microbiology and Laboratory Diagnostics — 5 methods
- Department of Biochemistry and Biopharmaceuticals — 3 methods
- Department of Falsified Medicines and Medical Devices — 3 methods
- Department of Epidemiology and Clinical Microbiology National Reference Centre for the Diagnostics of Bacterial Infections of the Central Nervous System (KOROUN) — 1 method
Laboratory locations
- NARODOWY INSTYTUT LEKÓW (main site) — ul. Chełmska 30/34, 00-725 Warszawa
- Department of Pharmaceutical Microbiology and Laboratory Diagnostics
- Department of Falsified Medicines and Medical Devices
- Department of Biochemistry and Biopharmaceuticals
- Department of Epidemiology and Clinical Microbiology
Certificate information
- Issue date
- 09.07.2026
- Issue no.
- 25
Accreditation scope — test methods (17)
| No. | Test object | Methodology / Parameters | Technique | Reference document | |
|---|---|---|---|---|---|
| Department of Pharmaceutical Microbiology and Laboratory Diagnostics | |||||
| 1 | Other products: medicinal products, medical devices, biocidal products | Sterility | Methods: direct plating, filtration through membrane filters | Ph.Eur.:2.6.1;04/2011:20601 corr. 7.7 | FP:2.6.1;04/2011:20601 amendment 7.7 | |
| 2 | Other products: medicinal products, medical devices, biocidal products | Microbiological purity | Methods: direct plating, filtration through membrane filters | Ph. Eur.:2.6.12; 01/2025:20612 | FP:2.6.12; 01/2025:20612 | Ph.Eur.:2.6.13;01/2021:20613 | FP:2.6.13; 01/2021:20613 | Ph.Eur.:2.6.31;01/2014:20631 | FP:2.6.31;01/2014:20631 | |
| 3 | Other products: medicinal products, medical devices, biocidal products | Antimicrobial protection efficacy | Methods: direct plating, filtration through membrane filters | Ph.Eur.:5.1.3;04/2022:50103 | FP:5.1.3;04/2022:50103 | |
| 4 | Other products: medicinal products, medical devices, biocidal products | Microbial population | Method: filtration through membrane filters | PN-EN ISO 11737-1 :2018 | |
| 5 | Other products: medicinal products/ antibiotics and chemotherapeutics | Activity of the active substance | Method: diffusion (cylinder-plate) | Ph.Eur.:2.7.2;01/2020:20702 | FP:2.7.2;01/2020:20702 | USP:81 | |
| Department of Falsified Medicines and Medical Devices | |||||
| 6 | Medicinal products, organic substances/compounds: - synthetic; - of natural origin; - biopharmaceuticals | Qualitative composition: identification confirmation of identity |
Nuclear magnetic resonance spectrometry method ( NMR) | Ph.Eur.:2.2.33; 01/2009:20233 | |
| 7 | Medicinal products, Medical devices containing active substances, Food supplements, foodstuffs for particular nutritional uses, Household chemical products, Organic substances/compounds | Qualitative composition: identification confirmation of the identity of compounds in the mass range 90-1100 m/z using the NIL mass spectra database and mass spectra libraries available on-line: MassBank, Metlin, m/z Cloud, EMCDDA-EDND, SWGDRUG, Response 90-1100 m/z |
High-performance liquid chromatography with tandem mass spectrometry (HPLC-MS/MS) | Ph.Eur.:2.2.43; 01/2008:20243 | FP: 2.2.43; 01/2008:20243 | |
| 8 | Crystalline substances | Qualitative composition: identification confirmation of the polymorphic form |
X-ray powder diffraction method (XRPD) | Ph.Eur.:2.9.33; 01/2022:20933 | FP:2.9.33; 01/2022:20933 | |
| Department of Biochemistry and Biopharmaceuticals | |||||
| 9 | Medical devices, Pharmaceutical products | Bacterial endotoxin content. | Gel-clot technique; Method A: Limit test; Method B: Semi-quantitative test | Ph.Eur.:2.6.14; 01/2018:20614 | FP:2.6.14; 01/2018:20614 | |
| 10 | Medical devices, Pharmaceutical products | Genotoxicity – Ames test | PN-EN ISO 10993-3:2014 | ||
| 11 | Medical devices | Cytotoxicity | Method: on extracts, in direct contact, agar diffusion, filter diffusion | PN-EN ISO 10993-5:2009 | |
| Department of Epidemiology and Clinical Microbiology National Reference Centre for the Diagnostics of Bacterial Infections of the Central Nervous System (KOROUN) | |||||
| 12 | Bacterial strains | Identification of microorganisms Streptococcus spp. Neisseria meningitidis Listeria spp. Haemophilus spp. Enterobacterales Staphylococcus spp. Enterococcus spp. |
Culture method; Biochemical method; Serological method; Microscopic method; Mass spectrometry method | ZE/PB-01 issue 2 of 15.04.2025, based on the reagent and equipment manufacturers' instructions | |
| Department of Epidemiology and Clinical Microbiology National Reference Centre for Antimicrobial Susceptibility (KORLD) | |||||
| 13 | Bacterial strains | Identification of microorganisms Staphylococcus spp. Streptococcus spp. Enterococcus spp. Listeria spp. Corynebacterium spp. Enterobacterales Pseudomonas spp. Acinetobacter spp. Stenotrophomonas maltophilia Burkholderia cepacia complex Haemophilus spp. Moraxella catarrhalis Pasteurella spp. |
Culture method; Biochemical method; Serological method; Microscopic method; Mass spectrometry method | ZE/PB-01 issue 2 of 15.04.2025, based on the reagent and equipment manufacturers' instructions | |
| 14 | Bacterial strains | Antimicrobial susceptibility of microorganisms Staphylococcus spp. Streptococcus spp. Enterococcus spp. Listeria spp. Corynebacterium spp. Enterobacterales Pseudomonas spp. Acinetobacter spp. Stenotrophomonas maltophilia Burkholderia cepacia complex Haemophilus spp. Moraxella catarrhalis Pasteurella spp. |
Disc diffusion method | ZE/PB-02 issue 1 of 15.05.2020, based on EUCAST and CLSI recommendations | |
| 15 | Bacterial strains | Microbial resistance mechanisms Staphylococcus spp. : methicillin resistance mechanism, MLSB resistance mechanism Streptococcus spp.: MLSB resistance mechanism Streptococcus pneumoniae: mechanisms of resistance to ß-lactam antibiotics Enterococcus spp.: high-level aminoglycoside resistance mechanisms, glycopeptide resistance mechanisms Enterobacterales: mechanisms of resistance to ß-lactam antibiotics - production of ESBL and AmpC ß-lactamases and KPC, MBL and OXA-48 carbapenemases Pseudomonas spp.: mechanisms of resistance to ß-lactam antibiotics - production of ESBL ß-lactamases and KPC and MBL carbapenemases Acinetobacter spp.: mechanisms of resistance to ß-lactam antibiotics - production of ESBL ß-lactamases and KPC and MBL carbapenemases Haemophilus spp.: mechanisms of resistance to ß-lactam antibiotics - production of ß-lactamase, detection of changes in PBP proteins |
Disc diffusion method | ZE/PB-02 issue 1 of 15.05.2020, based on EUCAST and CLSI recommendations | |
| 16 | Bacterial strains | Minimum inhibitory concentration (MIC) Staphylococcus spp. Streptococcus spp. Enterococcus spp. Listeria spp. Corynebacterium spp. Enterobacterales Pseudomonas spp. Acinetobacter spp. Stenotrophomonas maltophilia Burkholderia cepacia complex Haemophilus spp. Moraxella catarrhalis Pasteurella spp. |
Gradient strip method; Broth microdilution method | ZE/PB-03 issue 1 of 15.05.2020, based on the reagent manufacturers' instructions and the EUCAST and CLSI recommendations | ZE/PB-04 issue 2 of 30.04.2024, based on the EUCAST and CLSI recommendations | |
| 17 | Bacterial strains | Production of carbapenemases by: Enterobacterales Pseudomonas spp. Acinetobacter spp. |
Biochemical method; Culture method | ZE/PB-05 issue 1 of 15.05.2020, based on the publications: - Nordmann P, Poirel L, Dortet L. Rapid detection of carbapenemase-producing Enterobacteriaceae. Emerg Infect Dis. 2012 Sep;18(9):1503-7 - Dortet L, Poirel L, Nordmann P. Rapid detection of carbapenemase-producing Pseudomonas spp. J Clin Microbiol. 2012 Nov;50(11):3773-6 - Dortet L, Poirel L, Errera C, Nordmann P. CarbAcineto NP test for rapid detection of carbapenemase-producing Acinetobacter spp. J Clin Microbiol. 2014 Jul;52(7):2359-64. | ZE/PB-06 issue 1 of 15.05.2020, based on the publication: van der Zwaluw K, de Haan A, Pluister GN, Bootsma HJ, de Neeling AJ, Schouls LM. The carbapenem inactivation method (CIM), a simple and low-cost alternative for the Carba NP test to assess phenotypic carbapenemase activity in gram-negative rods, PLoS One. 2015 Mar 23; 10(3):e0123690 | |
Reference standards (29)
FP: 2.2.43; 01/2008:20243
FP:2.6.12; 01/2025:20612
FP:2.6.13; 01/2021:20613
FP:2.6.14; 01/2018:20614
FP:2.6.1;04/2011:20601 amendment 7.7
FP:2.6.31;01/2014:20631
FP:2.7.2;01/2020:20702
FP:2.9.33; 01/2022:20933
FP:5.1.3;04/2022:50103
PN-EN ISO 10993-3:2014
PN-EN ISO 10993-5:2009
PN-EN ISO 11737-1 :2018
Ph. Eur.:2.6.12; 01/2025:20612
Ph.Eur.:2.2.33; 01/2009:20233
Ph.Eur.:2.2.43; 01/2008:20243
Ph.Eur.:2.6.13;01/2021:20613
Ph.Eur.:2.6.14; 01/2018:20614
Ph.Eur.:2.6.1;04/2011:20601 corr. 7.7
Ph.Eur.:2.6.31;01/2014:20631
Ph.Eur.:2.7.2;01/2020:20702
Ph.Eur.:2.9.33; 01/2022:20933
Ph.Eur.:5.1.3;04/2022:50103
USP:81
ZE/PB-01 issue 2 of 15.04.2025, based on the reagent and equipment manufacturers' instructions
ZE/PB-02 issue 1 of 15.05.2020, based on EUCAST and CLSI recommendations
ZE/PB-03 issue 1 of 15.05.2020, based on the reagent manufacturers' instructions and the EUCAST and CLSI recommendations
ZE/PB-04 issue 2 of 30.04.2024, based on the EUCAST and CLSI recommendations
ZE/PB-05 issue 1 of 15.05.2020, based on the publications: - Nordmann P, Poirel L, Dortet L. Rapid detection of carbapenemase-producing Enterobacteriaceae. Emerg Infect Dis. 2012 Sep;18(9):1503-7 - Dortet L, Poirel L, Nordmann P. Rapid detection of carbapenemase-producing Pseudomonas spp. J Clin Microbiol. 2012 Nov;50(11):3773-6 - Dortet L, Poirel L, Errera C, Nordmann P. CarbAcineto NP test for rapid detection of carbapenemase-producing Acinetobacter spp. J Clin Microbiol. 2014 Jul;52(7):2359-64.
ZE/PB-06 issue 1 of 15.05.2020, based on the publication: van der Zwaluw K, de Haan A, Pluister GN, Bootsma HJ, de Neeling AJ, Schouls LM. The carbapenem inactivation method (CIM), a simple and low-cost alternative for the Carba NP test to assess phenotypic carbapenemase activity in gram-negative rods, PLoS One. 2015 Mar 23; 10(3):e0123690