Egyptian Drug Authority

 
Services > Registration > Stability

Stability Directorate

About Us: 

Stability directorate: is a part of General Directorate of Registration in Central Administration for Pharmaceutical Affairs.
  Internal Organogram

Stability study: is the study that reflects the effect of temperature and humidity on the stability of finished product in its final packaging material during storage period to determine shelf-life and storage conditions (as defined by International Council for Harmonization).

Shelf-life: is the time period during which a product is expected to remain within the approved shelf-life specifications, provided that it is stored under the conditions defined on the container label (as defined by International Council for Harmonization).

Shelf-life specifications: is the combination of physical, chemical, biological and microbiological tests and acceptance criteria that determine the suitability of active substances throughout its re-test period, or that a product should meet throughout its shelf-life (as defined by International Council for Harmonization)

Mission: 

Stability Directorate ensures the provision of safe, effective, and efficient pharmaceutical products and aims to maintain close communication and to respond quickly to our customer's needs in an environment that encourages excellence, teamwork, compassion and continuous improvement.

Vision: 

Stability Directorate strives to provide superior, fast, and high quality services with transparency and impartiality complying with all legislation hoping for thrive of pharmaceutical industry in Egypt and protection and promotion of public health.

Tasks: 

Stability Directorate is responsible for:
1- Receiving and preparing of stability studies presented by the companies for:
• Registration or re-registration of human pharmaceutical products, biological products, veterinary products, dietary supplements and herbal medicine products, disinfectants and insecticides 
• Approval of stability studies represented to fulfill requests of committee of variation for registered pharmaceutical products including human pharmaceutical products, biological products, veterinary products, food supplements, cosmetics, disinfectants and insecticides
• Approval of accelerated and long term stability study of the first three production batches for human pharmaceutical products represented for issuing of final license
Then displaying of prepared stability studies on Scientific Specialized Committee to assess stability studies to be evaluated and granted shelf-life, storage conditions, final packaging material and composition in case of newly registered products (human pharmaceutical products, veterinary products and dietary supplements and herbal medicine products) and approval of any variation for registered pharmaceutical products

2- Receiving and preparing of subjects and appeals which include:
• Subjects transferred from head of CAPA
• Subjects transferred from other general directorates in CAPA
• Subjects transferred from departments and other directorates in general directorate of registration
• Appeals submitted by company
Then displaying of prepared subjects and appeals on Scientific Specialized Committee to assess stability studies to be evaluated and taking decisions concerning them

3- Implementing of committee decisions taken by committee members and issuing letters to inform concerned entity with committee decisions

4- Random and periodical inspection of  licensed stability centers and stability sections of different pharmaceutical factories  after recieval of monthly plan submitted by stability centers and stability sections of different pharmaceutical factories to ensure that they follow the guidelines and regulations established by scientific specialized committee to assess stability studies and approved by head of Central Administration for Pharmaceutical Affairs and to ensure that the stability studies were actually performed through checking the electronic data and paper documentation
 
5- Inspection of stability study of certain products after recieval of letter addressed to stability inspection department including request of stability studies reception department to check stability study of certain product before setting appointment date for receiving its stability study or request of scientific specialized committee to assess stability studies to check certain comment in stability study of the product

6- Attending initial inspection for licensing of stability centers after recieval of letter transferred from general directorate of licensing to participate as a member in the committee formed including two members of scientific specialized committee to assess stability studies, stability inspection department team, and general directorate of licensing team


Contact Information: 

Email: stability@eda.moheatlh.gov.eg
Tel.: +202 – 23684288 / +202 – 23648769 / +202 – 25354100 Ext.:1301
Fax: +202 - 23684194

Ministerial Decrees: 

ministerial decree 370
ministerial decree 296
ministerial decree 297
ministerial decree 425
ministerial decree 820

Announcements: 

Announcement for Stability Centers and Stability Sections of pharmaceutical factories
Announcement for non HPLC analytical method
Announcement for links for reservation of appointments for wednesday and thursday

Stability Inspection Department: 

Guidelines for initial inspection for licensing stability centers and inspection of licensed stability centers or stability sections of pharmaceutical factories
Commitment for correction
Monthly plan

Stability Studies Reception Department: 

Checklists: 
Checklist for stability study of imported drug product CTD
Checklist for stability study of imported drug substance CTD
Checklist for stability study of dietary supplements and herbal medicine products (newre-reg)
Checklist for stability study of antiseptics
Checklist for stability study of biological product (newre-reg)
Checklist for stability study of human pharmaceutical product (imported new re-reg)
Checklist for stability study of human pharmaceutical product (new296)
Checklist for stability study of human pharmaceutical product (new425)
Checklist for stability study of human pharmaceutical product (re-reg)
Checklist for stability study of human pharmaceutical product (re-reg425)
Checklist for stability study of human pharmaceutical product of production batches
Checklist for stability study of insecticides
Checklist for stability study of subjects
Checklist for stability study of variation of biological product
Checklist for stability study of veterinary products (newre-reg)

File Content and Requirements for composition review: 
File Content for Antiseptics and Insecticides
File Content for Biological Products
File Content for Dietary Supplement and herbal medicine product
File Content for Human Pharmaceutical Product (new 296)
File Content for Human Pharmaceutical Product (New 425)
File Content for Human Pharmaceutical Product (Production batches)
File Content for Variation
File Content for Veterinary Products
File Contents for Human Pharmaceutical Product (Re-reg 296)
File Contents for Human Pharmaceutical Product (Re-reg 425)
Requirments for composition review

forms and commitments: 
Application Form for Comment
Application Form for New Appointment
CD commitment
Responsiblity Certificate
Stability Study Enquiry Request
Storage Condition Commitment (for accelerated stability study)
Storage Condition Commitment (for storage at 25 degree celsius)
Summary Sheet of Stability Study

Guidelines: 
Guidelines for stability studies

Steps for applying to set appointment: 
Steps for applying to set appointment
Flowchart for recieving stability studies
 
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