General Information
Tipo de proveedor de servicios
Laboratorio de pruebas
Breve descripción
NNLE "Mi Lab" is a laboratory with international standards. It is equipped with modern equipment and is staffed by qualified staff who are constantly focused on improving their professional skills. The field of activity of the testing laboratory is the analysis of pharmaceutical products, veterinary drugs and animal feed on chemical and microbiological parameters.
DIRECCIÓN POSTAL
Jumashevi str
0151 Tbilisi
Georgia
Número de teléfono
+995 32 288 78 38
CORREO ELECTRÓNICO
info [at] milab.ge
Estatus legal
Privado
¿Ha sido acreditado el laboratorio en algún ámbito?
No
Alcance de la acreditación
Pharmaceutical drugs, Veterinary drugs and Animal Feed
https://gac.gov.ge/upload/accredited_bodies/files/4e5a76da30dae2a9b3166a25540ea183.pdf
https://gac.gov.ge/upload/accredited_bodies/files/4e5a76da30dae2a9b3166a25540ea183.pdf
Organismo de acreditación
National Unified body of Accreditation - Accreditation Center (GAC)
Certificate : GAC-TL-0324
Certificate : GAC-TL-0324
¿Tiene el laboratorio otras sedes?
No
Personnel
Chief Executive Officer (CEO) / Head of Organization
Nombre del director general
Khatia Tchkonidze
Teléfono del director general
Correo electrónico del director general
milab.geo [at] gmail.com
Total laboratory personnel
Total de personal de laboratorio
9
Personal masculino del laboratorio
1
Personal feminino del laboratorio
8
Technical personnel
Total de personal técnico
3
Personal técnico masculino
1
Personal técnico femenino
2
Technical Information
Testing
Servicios de laboratorio ofrecidos
Biológico
Médico
Químico
Otros
Otros servicios de laboratorio de pruebas
Pharmaceutical drugs,
Animal Feed
Animal Feed
Alcance de los servicios ofrecidos
Objeto de ensayo o producto probado o matrices
Pharmaceutical medicinal products, including those used in veterinary medicine in the form of dosed pharmaceutical products for therapeutic or prophylactic purposes, not packing.
Pharmaceutical medicinal products, including those used in veterinary medicine in the form of dosed pharmaceutical products for therapeutic or prophylactic purposes, packing dosage medicinal forms (Including drugs in the form of transdermal systems) or packings for retail sale.
Pharmaceutical medicinal products, including those used in veterinary medicine in the form of dosed pharmaceutical products for therapeutic or prophylactic purposes, packing dosage medicinal forms (Including drugs in the form of transdermal systems) or packings for retail sale.
Parámetro de prueba/propiedades medidas
Physical -Chemical and Microbiological parameters
Tipo de prueba/instrumentación utilizada
Determination Average weight
Density determination
Determination of pH
Sulfated ash
Total ash
Essential oils
Disintegration time of tablets and capsules
Dissolution
Determination friability of tablets
Measuring refractive index
Assay Determination
Determination of nitrogen and total protein
Measuring of Ethanol content
Identification Quantity assay, and Determination of Clarity
Identification and quantitative analysis
Determination of Volatile Substances and moisture determination
General reaction of quality
Visual, color, odor, size, hermetic, time of sedimentation, uniformity
Determining the acid number;
Saponification value
Ester Value
Nominal volume
Coloration
Clarity and degree
Particulate contamination
Determination of particle size
Microbiological assay of antibiotics
Determination of mesophilic anaerobic bacteria
Total number yeast and mold
Test for specified micro-organisms.
Bile-tolerant gram-negative bacteria
E.coli
Salmonella
P.aeruginosa
S.aureus
Sterility
Bacterial endotoxins
to use LAL-tests
Pyrogens
Toxicity
Density determination
Determination of pH
Sulfated ash
Total ash
Essential oils
Disintegration time of tablets and capsules
Dissolution
Determination friability of tablets
Measuring refractive index
Assay Determination
Determination of nitrogen and total protein
Measuring of Ethanol content
Identification Quantity assay, and Determination of Clarity
Identification and quantitative analysis
Determination of Volatile Substances and moisture determination
General reaction of quality
Visual, color, odor, size, hermetic, time of sedimentation, uniformity
Determining the acid number;
Saponification value
Ester Value
Nominal volume
Coloration
Clarity and degree
Particulate contamination
Determination of particle size
Microbiological assay of antibiotics
Determination of mesophilic anaerobic bacteria
Total number yeast and mold
Test for specified micro-organisms.
Bile-tolerant gram-negative bacteria
E.coli
Salmonella
P.aeruginosa
S.aureus
Sterility
Bacterial endotoxins
to use LAL-tests
Pyrogens
Toxicity
Métodos
Eur. Ph. chapter 2.9.5
USP <2091>
Eur. Ph. chapter 2.2.5
The thirteenth Edition of Russian
ОФС.1.2.1.0014.15
USP<841>
Eur. Ph. chapter 2.2.3
USP<791>
Eur. Ph. chapter 2.4.14
Eur. Ph. chapter 2.4.16
USP <561>
Eur. Ph. chapter 2.8.12
Russian pharmacopeia XIII; ОФС.1.5.3.0010.15
Eur. Ph. chapter 2.9.1
USP <701>
Eur. Ph. chapter 2.9.3
USP <711>
Eur. Ph. chapter 1.4
USP <5.30>
Eur. Ph. chapter 2.9.7
USP <1216>
Eur. Ph. chapter 2.2.6;
USP <831>
USP36 <541>
Eur. Ph. chapter 2.5.9
Eur. Ph. chapter 2.9.33
USP <461>
Eur. Ph. chapter 2.9.10
USP <611>
Eur. Ph. chapter 2.2.25;
USP <197>
Eur. Ph. chapter 2.2.29;
USP <621>
Eur. Ph. chapter 2.2.32;
USP <731>
Eur. Ph. chapter 2.3.1
Eur. Ph. chapter 2.3.4, chapter 5.11.
Usp <1151>
Eur. Ph. chapter 2.5.1
USP <401>
Eur. Ph. chapter 2.5.6
USP <401>
Eur.Ph. chapter 2.5.2
USP <401>
Eur.Ph. chapter 2.9.17
USP <755>
USP <697>
Eur.Ph. chapter 2.2.2
Eur.Ph. chapter 2.2.1
Eur.Ph. chapter 2.9.20
USP <790>
Eur.Ph. chapter 2.9.38
State Pharmacopoeia of Georgia Volume 2
Eur.Ph. chapter 2.7.2
Eur.Ph. chapter 2.6.13
Eur.Ph. chapter 5.1.4
USP <61>
Eur.Ph. chapter 2.6.13
USP <62>
Eur.Ph. chapter 2.6.1
USP <71>
Eur.Ph. chapter 2.6.14
USP <85>
Eur.Ph. chapter 2.6.8
Eur.Ph. chapter 2.6.9
USP <2091>
Eur. Ph. chapter 2.2.5
The thirteenth Edition of Russian
ОФС.1.2.1.0014.15
USP<841>
Eur. Ph. chapter 2.2.3
USP<791>
Eur. Ph. chapter 2.4.14
Eur. Ph. chapter 2.4.16
USP <561>
Eur. Ph. chapter 2.8.12
Russian pharmacopeia XIII; ОФС.1.5.3.0010.15
Eur. Ph. chapter 2.9.1
USP <701>
Eur. Ph. chapter 2.9.3
USP <711>
Eur. Ph. chapter 1.4
USP <5.30>
Eur. Ph. chapter 2.9.7
USP <1216>
Eur. Ph. chapter 2.2.6;
USP <831>
USP36 <541>
Eur. Ph. chapter 2.5.9
Eur. Ph. chapter 2.9.33
USP <461>
Eur. Ph. chapter 2.9.10
USP <611>
Eur. Ph. chapter 2.2.25;
USP <197>
Eur. Ph. chapter 2.2.29;
USP <621>
Eur. Ph. chapter 2.2.32;
USP <731>
Eur. Ph. chapter 2.3.1
Eur. Ph. chapter 2.3.4, chapter 5.11.
Usp <1151>
Eur. Ph. chapter 2.5.1
USP <401>
Eur. Ph. chapter 2.5.6
USP <401>
Eur.Ph. chapter 2.5.2
USP <401>
Eur.Ph. chapter 2.9.17
USP <755>
USP <697>
Eur.Ph. chapter 2.2.2
Eur.Ph. chapter 2.2.1
Eur.Ph. chapter 2.9.20
USP <790>
Eur.Ph. chapter 2.9.38
State Pharmacopoeia of Georgia Volume 2
Eur.Ph. chapter 2.7.2
Eur.Ph. chapter 2.6.13
Eur.Ph. chapter 5.1.4
USP <61>
Eur.Ph. chapter 2.6.13
USP <62>
Eur.Ph. chapter 2.6.1
USP <71>
Eur.Ph. chapter 2.6.14
USP <85>
Eur.Ph. chapter 2.6.8
Eur.Ph. chapter 2.6.9
Estado de la acreditación
Sí
Objeto de ensayo o producto probado o matrices
Animal Feed
Parámetro de prueba/propiedades medidas
Physical -Chemical and Microbiological parameters
Tipo de prueba/instrumentación utilizada
Common ash
Nitrogen and protein
Moisture
Raw cell
Fat content
Energy cost
Enumeration of beta-glucuronidase-positive Escherichia coli
Detection and/or enumeretion Coliform
Enumeretion of Enterobacteriaceae
Detection of Salmonella spp
Enumeration Yeast and Mould
Enumeration of S.aureus
Nitrogen and protein
Moisture
Raw cell
Fat content
Energy cost
Enumeration of beta-glucuronidase-positive Escherichia coli
Detection and/or enumeretion Coliform
Enumeretion of Enterobacteriaceae
Detection of Salmonella spp
Enumeration Yeast and Mould
Enumeration of S.aureus
Métodos
Gost 32933-2014
ISO 5984:2002
ISO 5983-1:2005/2016
ISO 5983-2:2009/2016
Gost 57059-2016
Gost 54951-2012
ISO 6496:1999
ISO 6865:2000
Gost.31675-2012
ISO 6492:1999/2016
Gost13496.15/2016
MUK 4237-86
Iso 16649-2:2001/2015
ISO 4832:2016
Gost 31747-2012
ISO 21528:2/2017
ISO 6579-1:2020/2020
ISO 21527-2:2008
ISO 6888-1:2021/2021
ISO 5984:2002
ISO 5983-1:2005/2016
ISO 5983-2:2009/2016
Gost 57059-2016
Gost 54951-2012
ISO 6496:1999
ISO 6865:2000
Gost.31675-2012
ISO 6492:1999/2016
Gost13496.15/2016
MUK 4237-86
Iso 16649-2:2001/2015
ISO 4832:2016
Gost 31747-2012
ISO 21528:2/2017
ISO 6579-1:2020/2020
ISO 21527-2:2008
ISO 6888-1:2021/2021
Estado de la acreditación
Sí
Objeto de ensayo o producto probado o matrices
Medicinal products, including medicinal products used in veterinary medicine, eubiotics, probiotics, prebiotics, symbiotics, biologically active food additives used for therapeutic or prophylactic purposes in the form of dosage medicinal forms (including medicinal products in the form of transdermal systems) or packaged for retail sale
Tipo de prueba/instrumentación utilizada
Take a sample
Métodos
State Pharmacopoeia of Georgia Volume 1
MiL/TL/GP-SOP-02-01
MiL/TL/GP-SOP-02-01
Estado de la acreditación
Sí
¿Realiza el laboratorio un muestreo, a petición del cliente, de los productos que se van a analizar?
Sí
Proficiency Testing
¿Participa el laboratorio en ensayos de aptitud para los alcances acreditados?
Sí
¿Participa el laboratorio en ensayos de aptitud para los alcances acreditados?
No
Detalles del régimen de PT
LGC Proficiency Testing Animal Feed (AFPS)
AF047 - (Round 47) 17 Jan 2022
Moisture
Crude protein
Crude fat
Crude ash
Crude fibre
AF051 - (Round 51) 09 Jan 2023
Salmonella spp./ 25g (detected /not detected)
LGC Proficiency Testing Pharmaceutical
PH077 - (Round 77) 05 Jul 2021
UV
PH079 - (Round 79) 17 Jan 2022
Sterility; Identification of microorganism
PH082 - (Round 82) 17 Oct 2022
Total bacterial count
Staphylococcus aureus - Detection and Enumeration
E.coli - Detection and Enumeration
Bile-tolerant gram-negative bacteria - Detection and Enumeration
PH083 - (Round 83) 09 Jan 2023
Acid/Base Titration
pH
Density
Refractive index
AF047 - (Round 47) 17 Jan 2022
Moisture
Crude protein
Crude fat
Crude ash
Crude fibre
AF051 - (Round 51) 09 Jan 2023
Salmonella spp./ 25g (detected /not detected)
LGC Proficiency Testing Pharmaceutical
PH077 - (Round 77) 05 Jul 2021
UV
PH079 - (Round 79) 17 Jan 2022
Sterility; Identification of microorganism
PH082 - (Round 82) 17 Oct 2022
Total bacterial count
Staphylococcus aureus - Detection and Enumeration
E.coli - Detection and Enumeration
Bile-tolerant gram-negative bacteria - Detection and Enumeration
PH083 - (Round 83) 09 Jan 2023
Acid/Base Titration
pH
Density
Refractive index
¿Subcontrata el laboratorio el trabajo de pruebas a otros laboratorios?
No
Quality Control / Quality Management
¿Opera el laboratorio un sistema de control de calidad (CC) interno para garantizar la calidad de los resultados de las pruebas?
Sí
¿Opera el laboratorio un sistema de gestión (o sistema de gestión de la calidad) para garantizar la calidad de los resultados?
Sí
¿Está el sistema documentado en un manual de calidad?
Sí