Egyptian Drug Authority

 
Services > Inspection > Manufactures

Drug factories inspection departement

Scope

The department of manufacturing site inspection is responsible for ensuring that manufacturing companies are following regulations, legislations and GMP guidelines on their processes for manufacturing of medicines for human and veterinary use. The department aims to ensure that all pharmaceutical products introduced to the Egyptian markets are safe, effective and have the best quality.

Mission

To guarantee the quality, safety and efficacy of medicines totally or partially manufactured and made available to public and that good manufacturing practices (GMP) are the mainstay of quality assurance in pharmaceutical production and control

Duties

1.Inspect the Egyptian drug factories to assure their compliance with cGMP & local regulations.
2.Inspect drug factories outside Egypt as prerequisite for importation.
3.Participate in licensing committee to license new drug factories or new extensions.
4.Sample (raw material, bulks, random samples……etc)to be analyzed by NODCAR.
5.Allow drug release in response to NODCAR certificate of analysis
6.Supervise drug execution.
7.Initiate drug recall if necessary.
8. Taking critical decisions concerning consumer health according to risk assessment in case of complaints,non-conformities or non-compliances
9.taking technical decisions by coordinating high supreme committee for inspection & toxicology committee.
10. Risk assessment in case of complaint & non-conformities.

Goals

* To advance industry's GMP standard to an acceptable level using & developing the variety of experiences & technical expertise available in the country & calling in external expertise where needed. 
* To ensure means of an open-door policy, attempted to advice & guide without taking on the role of a consultant.

Important Remarks:


  Ministerial Decrees
  GMP Certificate Request


Contact Us

•Drug factories inspection department manager:Dr. Maram Abbas

•Group Heads:

-Dr. Amal Adel
-Dr. Amal Akef 
-Dr. Fibi Micheal
-Dr. Shaimaa Nabil
-Dr. Rasha Ahmed
-Dr. Nehal Kamal
-Dr. Nermin Mohammed
-Dr. Amany Tanani


•Administrative Staff:

-Dr. Krestien Magdy
-Dr. Mariam Ashery
-Dr. Reham Waheed
-Dr. Samar Mamdouh
-Dr. Dina Shehab
-Dr. Hanan Gameel


•Telephone:+202- 23684288, +202- 23648769, +202- 25354100

•Ext:1504 – 1505

•Email: dfi@eda.mohealth.gov.eg



 
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