- 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 ↓.
- Determination of Hepatitis B surface Antibodies by ELISA in biological products (Hepatitis B immunoglobulin) according to Ph. Eur. monograph 0722.
- 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.
- 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)
- 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)
- 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