Egypt - Apply for Certifcate of Good Manufacturing Practice
Compliance with GMP requirements entails minimum common sense sanitary and processing requirements applicable to all food processing establishments. Many food industry companies have implemented the GMP certification scheme for food processing as the foundation upon which they have developed and implemented other quality and food safety management systems, including HACCP, ISO 22000, SQF and ISO 9001.
All food manufacturers in Egypt are legally required by law to have an up-to-date Hazard Analysis Critical Control Point (HACCP) system and must be able to demonstrate its effectiveness in order to obtain a Good Manufacturing Practice Certificate.
A Good Manufacturing Practices (GMP) certificate provides independent verification and certification that the basic manufacturing practices and prerequisites necessary for the implementation of an effective Hazard Analysis Critical Control Point (HACCP) food safety program are being followed.
Many food industry companies have implemented the Good Manufacturing Practice certification scheme for food processing as the foundation upon which they have developed and implemented other quality and food safety management systems, including HACCP, ISO 22000, SQF and ISO 9001.
Good Manufacturing Practices are a set of regulations, codes, and guidelines for the manufacture of:
- Drug substances and drug products in Egypt
- Medical devices in Egypt
- In vivo and in vitro diagnostic products in Egypt
- Foods in Egypt.
- Good Laboratory Practice
A Good Manufacturing Practices (GMPs) are an essential foundation for the development and implementation of successful HACCP plans. Food safety systems based on the HACCP principles have been successfully applied in food processing plants, retail food stores, and food service operations.
All food manufacturers companies both local and international in Egypt are Eligible for this certificate.
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- Hygiene: Pharmaceutical manufacturing facility must maintain a clean and hygienic manufacturing area.
- Controlled environmental conditions in order to prevent cross contamination of drug product from other drug or extraneous particulate matter which may render the drug product unsafe for human consumption.
- Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
- Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary.
- Instructions and procedures are written in clear and unambiguous language. (Good Documentation Practices)
- Operators are trained to carry out and document procedures.
- Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the drug was as expected. Deviations are investigated and documented.
- Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
- The distribution of the drugs minimizes any risk to their quality.
- A system is available for recalling any batch of drug from sale or supply.
- Complaints about marketed drugs are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective drugs and to prevent recurrence.
- The key information required is as follows
1. Application is on Good manufacturing practice single product basis
2. Written application stating name of manufacturer and name (and brand, if applicable) of product.
3. Completed Central Administration for Pharmaceutical Affairs General Inspection Department application form (Form D-REG/001)
4. Certificate of Incorporation with the Corporate Affairs Commission, if a company
5. Five (5) copies of the product dossier
6. Three (3) packs of the products samples
7. Notarized original copy of the duly executed Power of Attorney from the product manufacturer (imported product)
8. Certificate of Manufacture issued by the competent health or regulatory authority in country of origin and authenticated by the Egyptian Mission in that country (if foreign import). Where there is no Egyptian mission, The British High Commission or an ECOWAS country Mission will authenticate.
9. If contract-manufactured, Contract Manufacturing Agreement, properly executed and notarized by a Notary Public in the country of manufacture.
10. Current World Health Organisation Good Manufacturing Practice Certificate for the manufacturer, authenticated by the Ethiopian Mission.
11. Certificate of Pharmaceutical Products (COPP) duly issued and authenticated
12. Current Superintendent Pharmacists license to practice issued by the Egyptian Pharmaceutical Authority.
13. Premises Registration License from Ethiopian Pharmacists Authority.
14. Certificate of Registration of brand name with trademark registry in the Ministry of Finance here in Egypt
15. Letter of invitation from manufacturer to inspect factory abroad, stating full name and location of plant.
16. The applicable fee payable only if documents are confirmed to be satisfactory. Nutriceuticals, medical devices and other regulated drug products have similar requirements, with minor variations. Specific details can be obtained from CAPAGID.
Good Manufacturing Practices are enforced in Egypt by SGS Egypt which is a world leader in third party certification and verification. They help to ensure that regulatory compliance is followed while demonstrating knowledge of the importance of producing and trading safe, quality food.
These are the stages involved in applying for a Good Manufacturing practice certificate.
- Stage one - Documentation
Here you are required to present the necessary documents issued by the competent Health Authority in the country of manufacture. These documents differ in some aspect depending on the class of product you want register.
- Some of the documents include Power of Attorney or contract manufacturing Agreement;
- Manufacturing license and free sale certificate,
- Trademark registration,certificate of incorporation/business name and many more.
Note: All the necessary documents must be found satisfactory before any other process can be carried out.
- Stage Two - Drug production Evidence
There must be evidence that the food product is manufactured according to Good Manufacturing Practice (GMP). in the case of imported drug products (from foreign country),The importer must submit evidence that they are licensed to manufacture Food products for sale in the country of origin.
- Stage Three - Authenticated from Health Authority
There must be evidence by the competent Health Authority, that the sale of the product does not constitute a contravention of the food laws of that country. i.e.Certificate of Pharmaceutical Product (COPP) that conforms to WHO format.The documents in respect of C1-3 shall be authenticated by the Ethiopian Mission in that country. In countries where no Egyptian Embassy or High Commission exists, any other Embassy or High Commission of any Commonwealth or North African countries can authenticate.
- Stage Four - Dossier
The applicant shall submit two (2) dossiers made out in accordance with the Agency’s format.
- Stage Five
Evidence of Trade Mark Approval for brand name from Ministry of Finance in Egypt should be submitted.
- Stage Six - Annual License to practice Pharmacist
Copy of current Annual License to Practice as a Pharmacist for the Superintendent Pharmacist issued by Ethiopian Pharmacists Authority should be submitted.
- Stage seven - Certificate of registration
Copy of Current Certificate of Registration Retention of Premises issued by Ethiopian Pharmacists Authority.
- Stage Eight - Comprehensive Certificate of Analysis
Comprehensive Certificate of analysis of the batch of food product submitted for registration processing shall be submitted.
- Stage Nine
After all the documents have been submitted ,a drug product can not be manufactured in Egypt, unless the factory is inspected and Certificate of Recognition is issued by Central Administration for Pharmaceutical Affairs General Inspection Department in Egypt. Then a certificate of Good manufacturing practice is issued.
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1)Copy of permit and receipt (One copy)
2)Dossier formated according to CAFPAGID’s requirements (one copy).
3)Vetting Samples (Three of each product)
4)Copy of Current Certificate of Registration Retention.
5)The documents in respect of C1-3
6)There must be evidence by the competent Health Authority.
7)Comprehensive Certificate of analysis
All payments to the Agency are payable by bank draft to the Ministry of Health Central Administration for Pharmaceutical Affairs General Inspection Department.One million LE (1,000,000:00) plus 5% .
A successful application attracts a Certificate of Registration with a validity period of five (5) years.
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The time line for Good manufacturing practice certificate in Egypt from registration to submission up to issuance of registration number is hundred (100) work days. However, this depends on satisfactory compliance by the applicant.
- Ministry of Health
- Central Administration for Pharmaceutical Affairs
General Inspection Department:
Tel.: +202 – 23684288 +202 – 23640368
Fax: +202 - 23684194
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