Bacterial Control Unit (BCU)
Bacterial Control Unit is the unit which is responsible for controlling and confirming quality of the domestic and imported bacterial products (e.g. vaccines and anti-sera), also performing sterility and bacterial endotoxin testing for all biological products in compliance with the international guidelines (e.g. WHO) and other related organizations guidelines.
• Bacterial control unit receives samples from
1- Lot release department
2- Registration department
3- Post marketing surveillance department
- Analysis and services offered by the unit
– Technical evaluation of the (CTD) introduced to NORCB for registering or Re-registering of domestic and imported biological products (e.g. vaccines and anti-sera)
– Summary protocol critical review for domestic and imported bacterial products (e.g. vaccines and anti-sera) according last updated international guidelines
– Performing all quality, safety, efficiency and potency testing for all domestic and imported bacterial products according to lot release policy of NORCB.
– Performing sterility and bacterial endotoxin testing for all biological products.
– Validation of tests performed to ensure their convenience and efficiency according to different international guidelines
– Performing trend analysis through different time intervals according to the most updated guidelines.
– Evaluation of variations submitted to bacterial vaccines and anti-sera according to the international guidelines
– Contributing in the periodical (GMP) good manufacturing practice inspection on bacterial vaccines and anti-sera manufacturing facilities in cooperation with the central agency of pharmaceutical affairs (CAPA)
All of the unit members are well trained, highly qualified for the all unit activities and most of them trained and certified from WHO,OSHA, NRA and others.
NORCB is WHO recognized and bacterial control unit is ISO/9001 certified and ISO/17025 accredited from TUV and EGAC respectively.