Blood products control unit
- Blood product quality control unit is one of the NORCB quality control units ensure the quality, efficacy and safety of imported plasma derived products e.g. human albumin, immunoglobulin, anti D products, antiheamoplilic factors, recombinant products and urine derived medicinal products.
- The Blood product control unit receives samples and documents from Lot Release department and Marketing Authorization department for testing the samples according to national and international guidelines. Also the unit tests the samples received from the Post Marketing Surveillance department.
- The unit reviews the summary protocol for each plasma derived lot need to be released and this is the most important step to ensure that the manufacturing process, the in process quality control tests and the quality control tests done on finished products are done according to the international reference.
- The unit reviews the marketing authorization files according to the common technical document for the registration of pharmaceuticals for human use: quality – M4Q(R1).
- Assessment of variation files of plasma derived products according to international guidelines by our senior assessors.
- Participating with CAPA in inspection of plasma derived products manufactures according to cGMP.
- The Blood product control unit is committed to meet or exceed the customer expectations by establishing and maintaining the international standards ISO 9001/2015 and ISO/IEC 17025/2005.
- The Blood control unit cooperates with other worldwide recognized NRAs (e.g PEI , NIBSC,….) for sharing our knowledge and experience, also participates in the WHO training programs for continuous improvement.
Our Creative Team
Ph/Reham Abdel Moniem
Ph/Mennat allah el sayed
QC Specialist Safety monitor & Evaluator & QC Specialist
Ph/Tarek Mohammed Salah
Ph/Hossni Abdel Hady