Viral Control Unit

Objectives and Mission:

Viral control unit (VCU) is one of certified and accredited laboratory among NORCB laboratories to ensure the safety and efficacy of viral vaccines and immunoglobulins by professional well-trained members trained by international organizations as WHO, EGAC, OSHA….etc.

Our Creative Team

Ph/Norhan Hassan

Unit Manager

Ph/Moushira Mamdouh

Technical Manager

Ph/Akram Mohamed

Quality Manager

Ph/Ahmed Emam

Safety Monitor & Evaluator Quality, control specialist

Ph/ Aya Elkassify

Quality control specialist

Ph/Noha Gamal

Quality control specialist

Ph/Yara Tarek

Quality control specialist

Ph/Mohamed Ezzat

Quality control specialist

Ph/ Marwa Mohamed

Quality control specialist

Ph/ Amal Badawy

Quality control specialist

Ph/Sara Talaat

Quality control specialist

VCU is responsible for quality control testing and technical assessment of viral vaccines and immunoglobulins, for example:

  • Hepatitis A vaccine
  • Hepatitis B vaccine
  • Human Papillomavirus vaccine
  • Immunoglobulins
  • Inactivated Poliomyelitis Vaccine
  • Influenza Vaccine
  • Measles, Mumps and Rubella (MMR) Vaccine
  • Oral Poliomyelitis Vaccine
  • Rabies Vaccine
  • Rotavirus vaccine

VCU receives samples and documents from:

1- Lot release (LR) department

2-Marketing Authorization (MA) department

3- Post marketing surveillance (PMS) department for testing and evaluation.

VCU apply different quality control techniques for viral vaccines and immunoglobulins following the authorized SOPs according to the international guidelines. Such techniques include:

  • Tissue culture technique (using cells and tissues outside the body in an artificial environment).
  • In vivo testing using laboratory animals.
  • Immunochemical assays (identification of a substance (especially a protein) by its action as an antigen e.g. {ELISA, gel immunodiffusion}.

 Analysis and services offered by the unit:

Review the manufacturer’s summary protocols and release test results in detail to ensure the manufacturing process is done according to international standard guidelines.

Participating in evaluation of marketing authorization files (Quality modules) for registration of viral vaccines according to International Council for Harmonization (ICH) guidelines.

Participating with Central Administration of Pharmaceutical Affairs (CAPA) in Good Manufacturing Practice (GMP) inspection of viral vaccines manufacturers according to cGMP guidelines.

Participating in collaborative studies including Proficiency Testing and inter-laboratory comparisons.

  • ISO 17025 accreditation for potency tests of Anti-HBV and Influenza vaccines.
  • Successfully participation in Proficiency testing and inter-laboratory comparisons for Anti-HBV, Influenza vaccines and MMR vaccine.
  • Establishment of database software system for improvement of NORCB documentation system
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