Hellenic Accreditation System S.A.
1st Annex F1A/6 to the Certificate No 244-3
SCOPE of ACCREDITATION
of the
Laboratory for Chemical Analysis of Medicines
of the
Division of Laboratories, National Organisation for Medicines
Tested
materials/products
Types of test/Properties
Applied standards/Techniques
Chemical tests
According to the monographs of current editions of European Pharmacopoeia (EP), Hellenic Pharmacopoeia
(ΕΦ), British Pharmacopoeia (BP), United States Pharmacopoeia (USP) and approved validated methods of
product files
Pharmaceutical
starting materials and
pharmaceutical
products
Identification and assay of active
substance
Test for related substances of
active substance
Identification and assay of active
substance
High Performance Liquid Chromatography
(HPLC) – (UV-Vis)
(MEE 9001)
Spectrophotometry UV-Vis
(MEE 9003)
Identification of active substance
Thin Layer Chromatography (TLC)
Test for related substances of
active substance
(MEE 9005)
Assay of active substance
Titrimetry (use of indicator)
(MEE 9006)
Potentiometric determination of
pH
Page 1 of 9
General method 2.2.3 EP of (ΜEΕ 9008)
1st , 2nd, 3rd , 4th ,5th and 6th Annex F1/6 to the Certificate ESYD No 244-3
02.06.2010
Tested
materials/products
Single-dose
pharmaceutical
products
Types of test/Properties
Applied standards/Techniques
Test for uniformity of content
General method 2.9.6 EP using high
performance liquid chromatography (HPLC) –
(UV-Vis)
(MEE 9007)
Semi-micro determination of
water
General method 2.5.12 EP (MEE 9011)
Physical tests
According to the monographs of current editions of European Pharmacopoeia (EP), Hellenic Pharmacopoeia
(ΕΦ), British Pharmacopoeia (BP), United States Pharmacopoeia (USP) and approved validated methods of
product files
Single-dose
pharmaceutical
products
Test for uniformity of mass /
Test for average mass
Tablets and capsules
Test for dissolution
General method 2.9.5 EP by weighing
(ΜΕΕ 9009) and specification of the product
dossier
General method 2.9.3 EP and assay of active
substance with HPLC-(UV-Vis) or
Spectrophotometry UV-Vis
(MEE 9002)
Test for disintegration
General method 2.9.1 EP
(ΜΕΕ 9010)
Site of asseseement : Permanent Laboratory premises, Mesogeion 284, Holargos, Athens
Approved signatories : V. Violakis, N. Megoulas, K. Koussoulos
This scope of Accreditation replaces the previous one dated 17.02.2010.
The Accreditation Certificate No 244-3, to ELOT EN ISO/IEC 17025:2005, is valid until 7.03.2014.
Athens, June 2nd 2010
Prof. Nicolaos D. Stathopoulos
Chairman of ESYD
Page 2 of 9
1st , 2nd, 3rd , 4th ,5th and 6th Annex F1/6 to the Certificate ESYD No 244-3
02.06.2010
Hellenic Accreditation System S.A.
2nd Annex F1B/6 to the Certificate No 244-3
SCOPE of ACCREDITATION
of the
Microbiological Laboratory
of the
Division of Laboratories, National Organisation for Medicines
Tested
materials/products
Types of test/Properties
Applied standards/Techniques
Microbiological tests
According to the monographs of current editions of European Pharmacopoeia (EP), Hellenic Pharmacopoeia
(ΕΦ), British Pharmacopoeia (BP) and United States Pharmacopoeia (USP)
General method 2.6.1 EP (MEE 7001)
Sterile
pharmaceutical
products and medical
devices
Sterility tests
Test for bacterial endotoxins
General methods 2.6.14 EP, Method A (gel-clot: limit
test) and Method B (gel-clot: semi-quantitative (MEE
7006)
Non sterile
pharmaceutical
products and
substances for
phaurmaceutical use
Test for microbial quality
General methods 2.6.12 and 2.6.13 EP (MEE 7002)
Cosmetic products
Test for microbial quality
General methods 2.6.12 and 2.6.13 EP and according
to Guidelines of The Cosmetic Toiletry and
Perfumery Association (CTPA) and The European
Cosmetic Toiletry and Perfumery Association
(COLIPA) (MEE 7003)
Pharmaceutical and
cosmetic products
Efficacy of antimicrobial
preservation
General method 5.1.3 (MEE 7005)
Page 3 of 9
1st , 2nd, 3rd , 4th ,5th and 6th Annex F1/6 to the Certificate ESYD No 244-3
02.06.2010
Tested
materials/products
Foodstuffs intended
for particular
nutritional uses and
food supplements
Types of test/Properties
Applied standards/Techniques
Horizontal method for the
enumeration of
microorganisms-Colonycount technique at 300C
ISO 4833:2003
Detection of Staphylococcus
aureus
General method EP 2.6.13
Detection of Salmonella spp
ISO 6579:2002
Enumeration of sulfitereducing bacteria growing
under anaerobic conditions
ISO 15213:2003
Enumeration of Bacillus
cereus-Colony-count
technique at 300C
ISO 7932:2004
Detection of Enterobacter
sakazakii
ISO/TS 22964:2006
Site of asseseement : Permanent Laboratory premises, Mesogeion 284, Holargos, Athens
Approved signatories : J. Lavdiotis, S. Gazi
This scope of Accreditation replaces the previous one dated 17.02.2010.
The Accreditation Certificate No 244-3, to ELOT EN ISO/IEC 17025:2005, is valid until 7.03.2014.
Athens, June 2nd 2010
Prof. Nicolaos D. Stathopoulos
Chairman of ESYD
Page 4 of 9
1st , 2nd, 3rd , 4th ,5th and 6th Annex F1/6 to the Certificate ESYD No 244-3
02.06.2010
Hellenic Accreditation System S.A.
3rd Annex F1C/6 to the Certificate No 244-3
SCOPE of ACCREDITATION
of the
Section for Pharmacopoeia and Other Laboratory Standards
of the
Division of Laboratories, National Organisation for Medicines
Tested
materials/products
Types of test/Properties
Applied standards/Techniques
Chemical tests
According to the monographs of current editions of European Pharmacopoeia (EP), Hellenic Pharmacopoeia
(ΕΦ), British Pharmacopoeia (BP) and United States Pharmacopoeia (USP)
Pharmaceutical
starting materials and
pharmaceutical
products
Identification and assay of active
substance
Spectrophotometry UV-Vis,
(MEE 9003)
Assay of active substance
Titrimetry (use of indicator)
(MEE 9006)
Identification and assay of active
substance
High Performance Liquid Chromatography
(HPLC) – (UV-Vis)
(MEE 9001)
Site of asseseement : Permanent Laboratory premises, Mesogeion 284, Holargos, Athens
Approved signatories : A. Tsoka, A.Makritis
This scope of Accreditation replaces the previous one dated 17.02.2010.
The Accreditation Certificate No 244-3 , to ELOT EN ISO/IEC 17025:2005, has been extended up to 7.03.2014.
.
Athens, June 2nd 2010
Prof. Nicolaos D. Stathopoulos
Chairman of ESYD
Page 5 of 9
1st , 2nd, 3rd , 4th ,5th and 6th Annex F1/6 to the Certificate ESYD No 244-3
02.06.2010
Hellenic Accreditation System S.A.
4th Annex F1D/6 to the Certificate No 244-3
SCOPE of ACCREDITATION
of the
Laboratory for Chemical Analysis of Feeding Stuffs, Dietary Products, Herbal
Medicines
of the
Division of Laboratories, National Organisation for Medicines
Tested
materials/products
Types of test/Properties
Applied standards/Techniques
Chemical tests
According to the monographs of current editions of European Pharmacopoeia (EP), Hellenic Pharmacopoeia
(ΕΦ), British Pharmacopoeia (BP) and United States Pharmacopoeia (USP) and approved validated methods
of product files
Veterinary
pharmaceutical
starting materials and
formulations
Assay of active substance
Spectrophotometry UV-Vis (MEE 9003)
Assay of active substance
Titrimetry (use of indicator) (MEE 9006)
Assay of active substance
High Performance Liquid Chromatography
(HPLC) – (UV-Vis)
Physical tests
According to the monographs of current editions of European Pharmacopoeia (EP), Hellenic Pharmacopoeia
(ΕΦ), British Pharmacopoeia (BP) and United States Pharmacopoeia (USP) and approved validated methods
of product files
Single-dose
formulations
Test of uniformity of mass
General method 2.9.5 EP by
weighing (ΜΕΕ 9009)
Site of asseseement : Permanent Laboratory premises, Mesogeion 284, Holargos, ATHENS
Approved signatories : K.Fakinou
This scope of Accreditation replaces the previous one dated 17.02.2010.
The Accreditation Certificate No 244-3 , to ELOT EN ISO/IEC 17025:2005, is valid until 7.03.2014.
Athens, June 2nd 2010
Prof. Nicolaos D. Stathopoulos
Chairman of ESYD
Page 6 of 9
1st , 2nd, 3rd , 4th ,5th and 6th Annex F1/6 to the Certificate ESYD No 244-3
02.06.2010
Hellenic Accreditation System S.A.
5th Annex F1E/6 to the Certificate No 244-3
SCOPE of ACCREDITATION
of the
Biological and Toxicological Laboratory
of the
Division of Laboratories, National Organisation for Medicines
Tested
materials/products
Types of test/Properties
Applied standards/Techniques
Chemical tests
According to the monographs of current editions of Hellenic Pharmacopoeia (ΕΦ), British Pharmacopoeia
(BP), United States Pharmacopoeia (USP)
Pharmaceutical
starting materials and
pharmaceutical
products
Identification and assay of active
substance
Spectrophotometry UV-Vis
(MEE 9003)
Test for related substances of active
substance
Thin Layer Chromatography (TLC) (MEE
9005)
Physical tests
According to the monographs of current editions of Hellenic Pharmacopoeia (ΕΦ), British Pharmacopoeia
(BP), United States Pharmacopoeia (USP)
Single-dose
pharmaceutical
products
Test for uniformity of mass /
Test for average mass
Tablets and capsules
Test for dissolution
Page 7 of 9
General method 2.9.5 EP by weighing
(ΜΕΕ 9009), and specification of the product
dossier
General method 2.9.3 EP and assay of active
substance with HPLC-(UV-Vis) or
Spectrophotometry UV-Vis (MEE 9002)
1st , 2nd, 3rd , 4th ,5th and 6th Annex F1/6 to the Certificate ESYD No 244-3
02.06.2010
Tested
materials/products
Tablets and capsules
Types of test/Properties
Test for disintegration
Applied standards/Techniques
General method 2.9.1 EP
(ΜΕΕ 9010)
Site of asseseement : Permanent Laboratory premises, Mesogeion 284, Holargos, Athens
Approved signatories : K.Loutsidis, G.Volikakis
This scope of Accreditation replaces the previous one dated 17.02.2010.
The Accreditation Certificate No 244-3, to ELOT EN ISO/IEC 17025:2005, is valid until 7.03.2014.
Athens, June 2nd 2010
Prof. Nicolaos D. Stathopoulos
Chairman of ESYD
Page 8 of 9
1st , 2nd, 3rd , 4th ,5th and 6th Annex F1/6 to the Certificate ESYD No 244-3
02.06.2010
Hellenic Accreditation System S.A.
6th Annex F1F/6 to the Certificate No 244-3
SCOPE of ACCREDITATION
of the
Laboratory for Chemical Analysis of Cosmetics and Other Products
of the
Division of Laboratories, National Organisation for Medicines
Tested
materials/products
Types of test/Properties
Applied standards/Techniques
Chemical tests
Cosmetic products
Determination of 2-phenoxy-ethanol,
methyl-, propyl-, and butyl-4hydroxybenzoate (parabens)
Medical gloves for
single use
Requirements and testing for
freedom of holes
High performance liquid chromatographic
(HPLC) method based on directive 96/45/EC
(MEE-6005)
ELOT EN 455-1:2000
Site of asseseement : Permanent Laboratory premises, Mesogeion 284, Holargos, Athens
Approved signatories : P.Klimentzou
This scope of Accreditation replaces the previous one dated 17.02.2010.
The Accreditation Certificate No 244-3 , to ELOT EN ISO/IEC 17025:2005, is valid until 7.03.2014.
Athens, June 2nd 2010
Prof. Nicolaos D. Stathopoulos
Chairman of ESYD
Page 9 of 9
1st , 2nd, 3rd , 4th ,5th and 6th Annex F1/6 to the Certificate ESYD No 244-3
02.06.2010