Egyptian Drug Authority

 
Services > Inspection > Biological Products

Biological Products Inspectorate

About the Biological Products Inspectorate

The Biological Products Inspectorate is a specialized department belonging to the General Pharmaceutical Inspectorate, CAPA, MOH, Egypt. Our inspectorate was newly established in March 2009 according to CAPA Head administrative decree No. 10 and 11/2009.


Mission Statement

Promotion of public health by assuring safety, quality and efficacy of all biological products which are affordable in Egypt.


Scope

Inspection of all biological products locally manufactured or imported


Duties

 Control of every single batch of biological products either locally manufactured or imported to Egypt from anywhere allowing its free sale in Egypt only
    after assuring safety, quality and efficacy of such batch.
 Confirm the implementation of the Good Manufacturing Practice including Good Storage and Good Distribution Practices.


Sampling

Sampling is done randomly according to an internal discipline.


Release

Release of sampled products either imported or produced locally is issued according to the analytical release from the National Organization for Drug Control & Research (NODCAR) for Insulin, Heparin & Hormones, or according to analytical release from National Organization for Research & Control of Biologicals (NORCB) for all other biological products.


Meetings

To meet with the Biological Products Inspectorate manager you are welcome on Sunday from 9 to 10:30 a.m. at the ground floor.


Contact Us

 
Tel: +202-23684288 – +202-23648769 – +202-25354100
Ext:1502
Email: BPI@eda.mohealth.gov.eg
Fax: +202-23684194 

Downloads


 
Back