Alexandria Company for Pharmaceuticals and Chemical Industries

Alexandria Co. for
Pharmaceutical and
Checmial Industries
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Design & Development for New& Re-registered Products

The division is responsible to plan and control the design for new products and develop the existing products.

It involves all Alex. Co. pharmaceutical & chemical industries  products under design and development.

 

Preparation of Product Registration

The division is responsible to obtain a registration certificate from the Egyptian Ministry of Health for pharmaceutical products ,veterinary products& medical appliances either for local marketing or exportation of the product according to their most recent  rules.

The protocol describes the stages which are followed to control the process involved in preparing a registration file for:

New proprietary products

Developed products

Under license products

Re-registered products which are products that are marketable & need to be re-registered at the end of the validity period of their registration certificate.

Design of Packaging Materials

The division is responsible to describe the process used to design the new forms of packaging materials for all dosage forms.

It involves the design of all packaging materials according to the requirements of the dosage forms  and according to the instructions of the M.O.H & the condition of the importing countries.

 

Technology

 

This division designs the formulation of all new products (sterile & non-sterile liquid products, solid & semi-solid products). The division is also responsible for the development of products which are already existing & mainly concerned with international specifications & satisfaction of the customer’s expectations regarding quality and price.

The division also deals with problems (trouble-shooting problem) that may appear after authorization of the master formula and manufacturing instructions of the product as it may be necessary to carry out verifications, documentation and approval of design changes in order to be re-issued and implemented.

Prospective validation.

It involves:

New proprietary & under license sterile & non sterile liquid products and solid & semi-solid products.

Developing the already existing products.

Dealing with all the troubleshooting of any problems the product is exposed to on the long run during the manufacturing process.

 

Methodology

 

The division is responsible for investigation of analysis methods for new products and ensuring the efficiency of the investigated methods according to the required specifications.

Evaluation of the analysis methods for the re-registered products.

Validation of analysis methods by stability indicating methods if available.

Following-up the stability of products under experiment and trial batches for new and developed products according to an approved stability testing protocol.

Establishment of new analysis methods of new proprietary products, developed and re-registered products & confirmation of the available analysis methods of under-license products & validation of the methods and following-up their stability.

 

Stability Testing

 

The stability testing protocol describes the steps which are necessary to be carried out when conducting a stability study with the aim of studying shelf-life of the product and preparing a stability report to be included in the registration file of the pharmaceutical product.

Stability studies are performed on the finished product in its final package. It is necessary for the purpose of derivation of expiry dates and to recommend storage conditions during the shelf life.

 

Export

 

The division is responsible for presenting all company products to the outsider customers in all foreign countries to choose their market needs.

Registration of the company in different foreign countries.

Presenting registration files for company products to different countries according to the requirements of each country. 

Dealing with the bids & tenders in foreign countries to prepare all necessary documents.