The Biotechnology unit implements many scientific and practical measures to ensure the quality, safety and efficacy of the biotechnological products, including:
- Granocyte colony stimulating factor (GCSF).
- Growth hormones.
- Monoclonal antibodies.
- R blood derivatives.
These are achieved by a technical team trained on the techniques of analysis and evaluation, and are able to perform the following tasks:
First: Practical tasks:
Conducting identity, potency and purity tests for biotechnological products that are received from (registration, lot release and post-marketing surveillance) departments using the following laboratory techniques:
Second: Technical tasks:
– Evaluation of all documents concerning biotechnological products for the following departments:
● Registration department:
Review the quality module of the registration files for biotechnological products, whether innovative or biosimilar, according to the international guidelines and issuing the technical evaluation report.
● Lot Release department:
Review all documents and certificates for all biotechnological products for release.
– The lab also implements the quality system throughout all the performed tasks.
Third: GMP Inspection:
The lab inspects local and international biotechnological factories in cooperation with the Central Administration of Pharmaceutical Affairs and ensures that the rules of good manufacturing practice are well implemented.