L-Thyroxine Tablet Forming and Packing

Following a request from the Belarusian, Russian and Ukrainian authorities, the European Commission established the Chernobyl Regional Programme as a part of the TACIS 1993 Nuclear Safety Programme. The programme was intended to assist those countries in dealing with the consequences of the Chernobyl accident.
The programme began with a rapid exercise to assess the needs of the three countries, identify actions already undertaken and define the key priorities for funding by the EC and other donors.
It was initially anticipated that first efforts would concentrate on actions to limit the consequences of soil contamination, but, subject to initial assessment, other actions dealing with the social and economic problems resulting from the Chernobyl accident could also be included. One of these actions was to provide for an improvement in the treatment of thyroid cancer in the populations in the affected countries.
One of the principal aids in managing thyroid cancer and treating other thyroid problems is L-Thyroxine, a replacement for the hormones naturally produced by the thyroid gland. As at May 1994 this was not produced in the Chernobyl affected regions meaning that the required supplies had to be imported.
It was estimated at the time that in Ukraine there were about 40,000 patients for whom L-Thyroxine was prescribed. The resulting overall requirement for L-Thyroxine was estimated at 55 million x 100 microgram tablets per annum. This gave rise to a significant importation cost in 1994 of about $650,000 per annum. The requirements in Belarus were about the same. Russian requirements were not considered under this project as it had been reported that a manufacturing facility was under construction in the country.
Consequently, a project was programmed under the TACIS 1993 Chernobyl regional programme for the design and installation of facilities, at the Borschahiwska Pharmaceutical Factory of the FARMAK Joint Stock Company in Ukraine, for the forming and packaging of L-Thyroxine tablets and subsequent storage and distribution of the drug for the Chernobyl affected regions.
The Terms of Reference for the project had been prepared under a previous contract (see 22782).

The aim of the present project was to perform the conceptual study and define in detail the pilot project, at the Borschahiwska Pharmaceutical Factory in Ukraine, to form, package, store and distribute tablets of L-Thyroxine from imported bulk supplies of the fine chemical. The main output of the contract was the technical specification for procurement of the TACIS-financed equipment supplies for the establishment of the facility.
The work to be performed included:
Determination of annual requirements of tablets of different concentrations of L-Thyroxine.
Determination of availability of raw materials and additives, and who shall develop the product formulation.
Definition of current regulations, codes and standards (security, QA etc.).
Collecting relevant data about existing facilities, buildings, utilities, laboratories, working conditions, staff, logistics, transport etc. at the Borschahiwska Pharmaceutical Factory.
Development of a general concept for the production facilities to meet the above requirements and conditions in the form of:
process description with tie-in points
material flow diagram
layouts
equipment lists
number of shifts to operate the plant.

Determination of all essential data and description of quantities and qualities of equipment to be purchased through TACIS funds in the form of technical specifications describing functional and technical requirements.
Establish an itemised cost estimate for the whole project considering the TACIS-financed part and the part supplied by the Beneficiary.
Description of the work programme and drawing up a time schedule for all major phases of the project, starting with procurement and proceeding through supplies, installation, testing, commissioning up to handing over of the plant. The target was to perform the work in 15 months.
All results of the above activities were compiled in the technical specifications and in comprehensive reports or documents.

The contract was signed in May 1995 and was completed in September 1996.
The Contractor prepared the technical specification for the facility equipment to be supplied under TACIS financing and developed an operation plan for the manufacturing facility.
The equipment was purchased through competitively tendered supply contracts. For information on the following stages of the project, see contracts 24030 and U5.09/93.