Accreditation

  • ISO 9001

NORCB was certified according to ISO 9001/2000 in 2008, certified according to ISO 9001/2008 in 2010 and certified according to ISO 9001/2015 in 2018.

  • World Health Organization (WHO)

On 10/2010, NORCB was recognized by the WHO as a pre-qualified organization.

  • ISO 17025

All of the four NORCB’s Control units are accredited by EGAC according to ISO/IEC 17025/2005 requirements in scope test(s) as shown in testing scope of accreditation .

  1. Determination of Hepatitis B surface Antibodies by ELISA in biological products (Hepatitis B immunoglobulin) according to Ph. Eur. monograph 0722.
  2. Test for identiy & heamagglutinin content of A/California strain in Inavtivated Influenza vaccine; Vaxigrip adult and pediatric, Influvac, Fluarix and Agrippal according to Ph. Eur. monograph 0158 and Ph. Eur. monograph 0869.

  1. Determination of bacterial endotoxin by gel clot technique according to European Pharmacopeia (2017) method 2.6.14 test for bacterial endotoxin (method A) & British pharmacopeia (2017) appendix XIVC test for bacterial endotoxin (method A)

  2. Determination of Tetanus and Diphtheria Toxoids content (Identity test) by Flocculation method according to Ph. Eur. (2017) Monograph 0445.Adsorbed DTP vaccine & Ph. Eur. (2017) method 2.7.27 flocculation value (lf) of diphtheria and tetanus toxins and toxoids (Ramon assay) in the following Vaccines:
  • DTP vaccines
  • Td (adult) vaccine
  • Ads TT vaccine
  • DTP-Hepatitis B- Hib
  • DT (pediatric)

  1. Determination of Prekallikrein Activator by chromogenic assay according to Ph. Eur. (2008): 2.6.15., Human albumin solution, Ph Eur monograph 0255 and WHO technical report series, No. 840, 1994. Applied to:
  • Human albumin
  • Human normal immunoglobulins for intravenous administration

  • Determination of Total Protein* in the following :
  • ·         Anti-sera

– Antitetanic serum 1500 IU/

– Tetanus antitoxin 1500 IU

– Antitetanic serum 30000 IU

– Polyvalent antisnake serum 10ml

– Polyvalent antiviper venom 10ml

– Antiscorpion antiserum 1ml

-antidiphtheric serum 5 ml

  • Alpha recombinant Human Erythropietin

– Epoetin 2000 IU/1 ml

– Epoetin 4000 IU/ 1ml

– EPIAO 2000 IU/ 1ml

– EPIAO 10000 IU/1ml

*In house method “CHEM.P.011” based on Eur.Ph 2011 2.5.33, total protein, method 5

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