Hellenic Accreditation System
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1 1 st Annex F1A/9 to the Certificate No Laboratory for Chemical Analysis of Medicines (ΕΦ), British Pharmacopoeia (BP), United States Pharmacopoeia (USP) and approved validated methods of product files Pharmaceutical starting materials and Test for related s of active High Performance Liquid Chromatography (HPLC) (UV-Vis) (MEE 9001) Spectrophotometry UV-Vis (MEE 9003) Identification of active Test for related s of active Thin Layer Chromatography (TLC) (MEE 9005) Assay of active Potentiometric determination of ph Titrimetry (use of indicator) (MEE 9006) General method EP of (ΜEΕ 9008) Page 1 of 9 1 st, 2 nd, 3 rd, 4 th,5 th and 6 th Annex F1/9 to the Certificate ESYD No
2 Single-dose Test for uniformity of content Semi-micro determination of water Physical tests General method EP using high performance liquid chromatography (HPLC) (UV-Vis) (MEE 9007) General method EP (MEE 9011) (ΕΦ), British Pharmacopoeia (BP), United States Pharmacopoeia (USP) and approved validated methods of product files Single-dose Test for uniformity of mass / Test for average mass General method EP by weighing (ΜΕΕ 9009) / specification product dossier Tablets and capsules Test for dissolution General method EP and assay of active with HPLC-(UV-Vis) or Spectrophotometry UV-Vis (MEE 9002) Test for disintegration General method EP (ΜΕΕ 9010) Site of asseseement : Permanent Laboratory premises, Mesogeion 284, Holargos, Athens Approved signatories : V. Violakis, E. Kyriakopoulou. The Accreditation Certificate No 244-4, to ELOT EN ISO/IEC 17025:2005, is valid until Director Laboratories Accreditation Division Page 2 of 9 1 st, 2 nd, 3 rd, 4 th,5 th and 6 th Annex F1/9 to the Certificate ESYD No
3 2 nd Annex F1B/9 to the Certificate No Microbiological Laboratory Microbiological tests (ΕΦ), British Pharmacopoeia (BP) and United States Pharmacopoeia (USP) Sterile and medical devices Sterility tests Test for bacterial endotoxins General method EP (MEE 7001) General methods EP, Method A (gel-clot: limit test) and Method B (gel-clot: semi-quantitative (MEE 7006) Non sterile and s for phaurmaceutical use Test for microbial quality General methods and EP (MEE 7002) Foodstuffs intended for particular nutritional uses Detection of Salmonella spp ISO 6579:2002 Detection of Enterobacter sakazakii ISO/TS 22964:2006 Site of asseseement : Permanent Laboratory premises, Mesogeion 284, Holargos, Athens Approved signatories : S. Gazi, V. Birtsas. Page 3 of 9 1 st, 2 nd, 3 rd, 4 th,5 th and 6 th Annex F1/9 to the Certificate ESYD No
4 The Accreditation Certificate No 244-3, to ELOT EN ISO/IEC 17025:2005, is valid until Director Laboratories Accreditation Division Page 4 of 9 1 st, 2 nd, 3 rd, 4 th,5 th and 6 th Annex F1/9 to the Certificate ESYD No
5 3 rd Annex F1C/9 to the Certificate No Section for Pharmacopoeia and Other Laboratory Standards (ΕΦ), British Pharmacopoeia (BP) and United States Pharmacopoeia (USP) Pharmaceutical starting materials and Assay of active Spectrophotometry UV-Vis, (MEE 9003) Titrimetry (use of indicator) (MEE 9006) High Performance Liquid Chromatography (HPLC) (UV-Vis) (MEE 9001) Site of asseseement : Permanent Laboratory premises, Mesogeion 284, Holargos, Athens Approved signatories : E. Georgiadou, A.Makritis The Accreditation Certificate No 244-4, to ELOT EN ISO/IEC 17025:2005, has been extended up to Director Laboratories Accreditation Division Page 5 of 9 1 st, 2 nd, 3 rd, 4 th,5 th and 6 th Annex F1/9 to the Certificate ESYD No
6 4 th Annex F1D/9 to the Certificate No Laboratory for Chemical Analysis of Feeding Stuffs, Dietary Products, Herbal Medicines (ΕΦ), British Pharmacopoeia (BP) and United States Pharmacopoeia (USP) and approved validated methods of product files Veterinary starting materials and formulations Assay of active Spectrophotometry UV-Vis (MEE 9003) Assay of active Titrimetry (use of indicator) (MEE 9006) Assay of active High Performance Liquid Chromatography (HPLC) (UV-Vis) Physical tests (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 EP by weighing (ΜΕΕ 9009) Site of asseseement : Permanent Laboratory premises, Mesogeion 284, Holargos, ATHENS Approved signatories : A. Tsigouri, K.Fakinou. The Accreditation Certificate No 244-4, to ELOT EN ISO/IEC 17025:2005, is valid until Director Laboratories Accreditation Division Page 6 of 9 1 st, 2 nd, 3 rd, 4 th,5 th and 6 th Annex F1/9 to the Certificate ESYD No
7 5 th Annex F1E/9 to the Certificate No Biological and Toxicological Laboratory According to the monographs of current editions of Hellenic Pharmacopoeia (ΕΦ), British Pharmacopoeia (BP), United States Pharmacopoeia (USP) Pharmaceutical starting materials and Test for related s of active Physical tests Spectrophotometry UV-Vis (MEE 9003) Thin Layer Chromatography (TLC) (MEE 9005) According to the monographs of current editions of Hellenic Pharmacopoeia (ΕΦ), British Pharmacopoeia (BP), United States Pharmacopoeia (USP) Single-dose Test for uniformity of mass / Test for average mass General method EP by weighing (ΜΕΕ 9009) / specification product dossier Tablets and capsules Test for dissolution General method EP and assay of active with HPLC-(UV-Vis) or Spectrophotometry UV-Vis (MEE 9002) Tablets and capsules Test for disintegration General method EP (ΜΕΕ 9010) Page 7 of 9 1 st, 2 nd, 3 rd, 4 th,5 th and 6 th Annex F1/9 to the Certificate ESYD No
8 Site of asseseement : Permanent Laboratory premises, Mesogeion 284, Holargos, Athens Approved signatories : G.Volikakis The Accreditation Certificate No 244-4, to ELOT EN ISO/IEC 17025:2005, is valid until Director Laboratories Accreditation Division Page 8 of 9 1 st, 2 nd, 3 rd, 4 th,5 th and 6 th Annex F1/9 to the Certificate ESYD No
9 6 th Annex F1F/9 to the Certificate No Laboratory for Chemical Analysis of Cosmetics and Other Products Cosmetic Determination of 2-phenoxy-ethanol, methyl-, propyl-, and butyl-4- hydroxybenzoate (parabens) High performance liquid chromatographic (HPLC) method based on directive 96/45/EC (MEE-6005) Physical tests Medical gloves for single use Requirements and testing for freedom from holes ELOT EN 455-1:2000 Site of asseseement : Permanent Laboratory premises, Mesogeion 284, Holargos, Athens Approved signatories : S. Gazi. The Accreditation Certificate No 244-4, to ELOT EN ISO/IEC 17025:2005, is valid until Director Laboratories Accreditation Division Page 9 of 9 1 st, 2 nd, 3 rd, 4 th,5 th and 6 th Annex F1/9 to the Certificate ESYD No
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