General Information
Type de prestataire
Laboratoire d'essais
Brève description
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.
Adresse postale physique
Jumashevi str
0151 Tbilisi
Géorgie
Numéro de téléphone
+995 32 288 78 38
E-mail
info [at] milab.ge
Statut juridique
Privé
Le laboratoire a-t-il été accrédité dans une quelconque portée ?
Non
Portée de l'accréditation
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
Organisme d'accréditation
National Unified body of Accreditation - Accreditation Center (GAC)
Certificate : GAC-TL-0324
Certificate : GAC-TL-0324
Le laboratoire dispose-t-il d'autres sites ?
Non
Personnel
Chief Executive Officer (CEO) / Head of Organization
Nom du PDG
Khatia Tchkonidze
Téléphone du PDG
Courriel du PDG
milab.geo [at] gmail.com
Total laboratory personnel
Total du personnel de laboratoire
9
Personnel de laboratoire masculin
1
Personnel de laboratoire féminin
8
Technical personnel
Total personnel technique
3
Personnel technique masculin
1
Personnel technique féminin
2
Technical Information
Testing
Services de laboratoire offerts
Biologie
Médical
Chimie
Autres
Autres services de laboratoire d'essais
Pharmaceutical drugs,
Animal Feed
Animal Feed
Portée des services offerts
Objet ou produit testé ou 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.
Paramètre d'essai/ propriétés mesurées
Physical -Chemical and Microbiological parameters
Type de test/instrumentation utilisé
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
Méthodes
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
Statut d'accréditation
Oui
Objet ou produit testé ou matrices
Animal Feed
Paramètre d'essai/ propriétés mesurées
Physical -Chemical and Microbiological parameters
Type de test/instrumentation utilisé
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
Méthodes
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
Statut d'accréditation
Oui
Objet ou produit testé ou 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
Type de test/instrumentation utilisé
Take a sample
Méthodes
State Pharmacopoeia of Georgia Volume 1
MiL/TL/GP-SOP-02-01
MiL/TL/GP-SOP-02-01
Statut d'accréditation
Oui
Le laboratoire procède-t-il à l'échantillonnage, à la demande du client, des produits à tester ?
Oui
Proficiency Testing
Le laboratoire participe-t-il à des essais d'aptitude pour les portées accréditées ?
Oui
Le laboratoire participe-t-il à des essais d'aptitude pour des champs d'application non accrédités ?
Non
Détails du régime 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
Le laboratoire sous-traite-t-il les essais à d'autres laboratoires ?
Non
Quality Control / Quality Management
Le laboratoire dispose-t-il d'un système interne de contrôle de la qualité (CQ) pour garantir la qualité des résultats des tests
Oui
Le laboratoire dispose-t-il d'un système de gestion (ou système de gestion de la qualité) pour garantir la qualité des résultats
Oui
Le système est-il documenté dans un manuel qualité ?
Oui