Company Profile

EIPICO is the civilized face of EGYPT in the pharmaceutical industries.
EIPICO was established as a private investment company in 1980 and started production in 1985.

EIPICO typically applies c.G.M.P. Regulations throughout the operational departments including evaluation of raw materials, calibration of equipments, control, holding and distribution of finished products.
EIPICO plant has a U-shaped design that minimizes mix-up and/or contamination by providing a single direction of material flow and is also surrounded by a green area as a protection from surrounding environment. Each pharmaceutical process has enough space to be carried out apart to minimize mix-up and/or cross contamination.
EIPICO is unique by its Sterile Areas (which are the largest in the Middle East and North African Region) that are environmentally controlled to obtain filtered air up to 97% - 99.7% particulate-free. The water purification system in EIPICO was designed to supply the production zones with demineralized and distilled water.

EIPICO was the Pioneer Egyptian Company to produce dosage forms like the spansule capsules (long-acting).
EIPICO also produces the non-traditional dosage forms such as the soft gelatin capsules, lyophilized products, gels, sprayers and effervescent tablets. The sound management enables EIPICO to seek the highest quality of raw material from the least expensive sources.

EIPICO products have been selected according to the actual needs taking into consideration the following priorities:
   -New products to replace the imported ones.
   -The new technology in pharmaceutical industry and researches.
   -The mutual co-operation between the Egyptian experts and researchers at EIPICO and those of the foreign international pharmaceutical companies according to license agreements.

Training Courses at EIPICO are of the highest possible level of the pharmaceutical industry.
EIPICO has its own Computer Network System of the latest generations connecting all various activities of production, storage and administration to optimize the Q.M.S.

EIPICO is distinguished by Direct Selling (Spot Delivery System). Its van cars cover all over Egypt.

EIPICO made License Agreements with a group of International Pharmaceutical Companies to produce their specialties to replace imported products, to cover the increasing demand and to acquire technology and know- how.

EIPICO, inaugurated its Biotechnology Center on August 6th, 2001 to contribute in the development of the drugs in all stages such as:
   - Synthesis of raw materials using biotechnology,
   - Bacterial and tissue utilization to produce Biotechnology and pharmaceutical products.
   - Extraction of active materials from natural products.
   - Pre-clinical studies including pharmacokinetics and pharmacodynamics.
   - Dosage forms studies including preformulation, stability studies and new drug delivery system.
   - Clinical trials.
   - Technology transfer.
   - Protein purification.

Due to the importance of human factor in this kind of research, the center is training its staff in-house and outside Egypt to increase professionalism.
Due to the fact that this center is of special nature, appliances and specific scientific apparatus in this field, it has been separated from the Research and Control Department with a separate headcount and budget. The new products will have a great impact medically and economically.
In 1996, EIPICO has been awarded the ISO - 9001 Certificate by the (BSI) for establishing, Implementing, and maintaining quality assurance systems in Design, Development, Production, Installation, and Servicing.
In 1999, EIPICO has also been awarded the ISO - 14001 Certificate regarding Environmental - friendly practices.

EIPICO is the largest local producer of pharmaceuticals in Egypt.
EIPICO exports their pharmaceutical products to Arab Countries, and to some African, Asian and East European Countries.
EIPICO is the industry leader, capturing 8% share of the local pharmaceutical market and approximately 20% of Egypt’s total drug exports.
   

QUALITY MANAGEMENT SYSTEM (Q.M.S.)  
                                                                           

QUALITY POLICY

EIPICO’s Q.M.S. meets the requirements of both: cGMP regulations and ISO 9001, issue 2000 Standards,
EIPICO’s Q.M.S. aims to ensure that the Quality of EIPICO’s products are:
   - Conforming to the updated specific requirements.
   - Safe.
   - Effective.
EIPICO’s Q.M.S. is the way to keep our Quality up. This goal is achieved only by building the Quality into the product during:
   - Planning of the Infrastructure needed to achieve conforming to product requirements.
   - Planning to improve competence, awareness and training to EIPICO’s human resources.
   - Customer communication.
   - Research and development.
   - Raw materials, packaging materials and other specific materials purchasing process.
   - Updating the technology and manufacturing techniques.
EIPICO’s Q.M.S. is not only documented and implemented but also its effectiveness is continuously measured, analysed and improved through monitoring and measuring of:
   - Customer satisfaction.
   - Internal audits.

Q.M.S. COMPLIES WITH THE CONCEPT OF PROCESS APPROACH

EIPICO’s Q.M.S. promotes the adoption of a “PROCESS APPROACH” when developing, implementing and improving the effectiveness of a Q.M.S., to enhance customer satisfaction by meeting customer requirements.
EIPICO’s Q.M.S. identifies and manages numerous linked activities, each activity using resources and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Often the output from one process directly forms the input to the next.
The application of that system within EIPICO together with the identification and interactions of these processes can be referred to as the “PROCESS APPROACH”. The advantage of the “PROCESS APPROACH” is that it provides the linkage between the individual processes; such approach emphasizes the importance of :
   i. Understanding and meeting requirements.
   ii. Obtaining results of process performance and effectiveness.
   iii. Continual improvement of processes based on objective measurement.
EIPICO’s “PROCESS APPROACH” shown in the following figure, shows that customers play a significant role in defining requirements as inputs.
EIPICO’s Q.M.S. monitors the Customer Satisfaction as follows:

   

 

PREMISES AND EQUIPMENTS

 

PRODUCTION SITES:
Semisolid and liquid dosage forms site.
Solid dosage forms site.
Sterile liquid dosage forms site.
Sterile powder dosage forms site.
Antibiotic powder dosage forms site.
Calibration lab.
Demineralized and distilled water station site.
Maintenance workshop site.

WAREHOUSES SITES
Receiving ware house site.
Material storage sites, including:
   Raw material storage site.
   Packaging material storage site.
   Penicillin storage segregated site.
   Inflammatory materials segregated storage site.
   Rejected materials segregated storage site.
   Quarantine site
   Finished product site
   Dispensing site


QUALITY SECTOR
Chemical quality control.
Biological quality control.
Quality assurance.
R&D Laboratories.
Biotechnology Center.


ASSISTING ENGINEERING FACILITIES SITES
   - Air condition: Boiler, compressor & air handling unit.
   - Electric power generators
   - Work shop

 



“Sterile Powder” Packaging Line
(Class 100 ) in One of the Biggest
Areas in the Middle East Region

The Sterile Area For Inspection and
Packaging of Dropper Bottles
(Class 100)


Vial Encapsulation of Lyophilised
Products Pioneered by EIPICO

“Water Demineralization” Station


Vial Encapsulation of Lyophilised
Products Pioneered by EIPICO

“Water Demineralization” Station


Automatic Filling Line For
“Syrups”

Integrated, Computerized
Preparation Unit for Tablets
Powder and Granules

Automatic Filling Line For
“Suspensions”

EIPICO Warehouses Applying
Good Storage Practice ( GSP )
Regulations

Tablets and Capsules Blistering
Machine

   

 

FUTURE OUTLOOK
                                                    

 

                                                    
BIOTECHNOLOGY CENTER
- Biotechnology is a broad term for classic and modern technology for the production of bioproducts using micro-organisms on large scale in purified form with less cost.
- The objective of Biotechnology Center is production of active materials using biotechnology techniques.
 

ACTION PLAN EIPICO will be the leading company in Egypt to apply biotechnology and bioengineering for the production of raw materials and formulation of Biopharmaceutical products.

1. Erythropoietin Hormone
Erythropoietin Hormone stimulates the production of red blood cells, so used in the treatment of acute anaemia caused by renal failure.
EPOFORM, the trade name of Erythropoietin Hormone produced by
EIPICO, which will be launched in 2003 in 3 concentrations:
EPOFORM 2000 I.U./ml Vial.
EPOFORM 4000 I.U./ml Vial.
EPOFORM 10000 I.U./ml Vial.


2. Hepatitis B-Vaccine:
The HBV Vaccine produced by recombinant DNA technologies in yeast.

FUTURE PLAN
1. Interferon
Which is mainly used in HCV patients as a combination therapy.
2. Colony Stimulating Factor (rhG - CSF)
It is one of the therapeutic agents used in cancer therapy as lmmunostimulant.
3. Human Growth Hormone
Which is used in Growth defects and for muscle mass increase in the elderly.
4. Interleukin - 2
Which is used as lmmunomodulator.

 



The Biotechnology Department Fermentation
Laboratory for production of genetic engineering
products such as hormones and vaccines using micro-
organisms e.g. bacteria, yeast or mammalian cells

Total Organic Carbon Analyzer (TOC)
I
t is used to test, accurately and rapidly , the quality
of water for injection intended for use in the
preparation of parenteral solutions. The test complies
with the latest edition of the USP.



High Performance thin Layer Chromatography
(HPLC).
It is used for the quantitative analysis of
minute amounts of related substances present in raw
materials and ofdegradation products present in the
finished goods


Fuming Cabinets Protect the analysis f
rom exposure
to toxic vapors of solvents. It is recommended for
safe environment and it complies with
ISO 14000


Latest Version of Atomic Absorption
Spectrophometry Apparatus (AAS)

It is capable of detecting the presence of trace
quantities of toxic elements such as lead , arsenic and
mercury. It is used to assure highest purity of raw
materials

“Profile Projector” with Accuracy 1Micron
The quality control laboratory sampling according to
the American military standards.

   

 

Organization Chart
                                                                                                             
EIPICO Organogram