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. Take critical decisions concerning consumer health according to risk assessment in case of complaints, non- conformities or non- compliance.
9.Issue GMP certificates for the exportation purpose.

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:

  • The Company should notify CAPA in case of closing any manufacturing line and before reopening it.
  • In case of changing the location of manufacturing of an already registered product or after opening a closed production area, the first three batches inspected, sampled and analyzed (at NODACR). Samples are withdrawn ONLY by CAPA inspectors.
  • The company should inform (using a formal letter) CAPA with names of Key Personnel in its manufacturing site. Any change of these names should be sent without delay to CAPA
  • The inspectors may check records of Production Batches & Regulated Substances (Narcotics).
  • The Manufacturing Site should establish a Serial Logbook. The new logbook must be signed & stamped by CAPA Inspection Department before starting to record on it.
  • Totally filled Logbooks After should be returned To CAPA Inspection Department to be reviewed & sealed before opening a new one.


  
Guide to GMP for Medicinal Products
  Draft of GLP Inspection Checklist
  GMP Checklist
  GMP Certificate Request
  Work Instructions
  Ministerial Decrees

Meetings

Every day after 4 pm by previous appointment.

Draft GMP Annexes

  Draft GMP Annexes

Draft regulation and guidance are documents that have been proposed and CAPA is waiting for your comments and feedbacks on this proposal otherwise the draft documents will be considered as the Egyptian guidance. 

Please address comments on this proposal, by 1st February 2011, to Drug Factories Inspection department, Central Administration for Pharmaceutical Affairs, Ministry of Health. DFI@eda.mohp.gov.eg

Contact Us

•Drug factories inspection department manager:Dr. Maha Edrees Mohammed

•Group Heads:

-Dr. Mary Foad
-Dr. Fibi Micheal
-Dr. Maram Abbas
-Dr. Dina El-Sayed
-Dr. Amal Akef 
-Dr. Amal Adel
-Dr. Shaimaa nabil


•Administrative Staff:

-Dr. Nermin Mohammed
-Dr. Dina Mahmoud
-Dr. Amal Adel
-Dr. Rasha Ahmed
-Dr. Krestien Magdy

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

•Ext:1504 – 1505

•Email: dfi@eda.mohp.gov.eg



 
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