Tunisia – Packtec announces the launch of a testing Laboratory for pharmaceutical packaging

July 15, 2013 12:48 pm0 commentsViews: 32
packtec

Packtec headquarter in Tunis

The Technical Centre for packaging and packing (Packtec), organizes in collaboration with the Spanish Technological Institute, packaging, packing and transportation (ITENE) an information half-day to the launch of the testing Laboratory for pharmaceutical packaging, on Thursday, April 18, 2013 at 8:30 am at the headquarters of CEPEX.

Program for this half-day is presentation of tasks and services of the laboratory, established to meet the needs and expectations of the pharmaceutical industry in terms of quality and safety of used packaging. The aim of the center is to continue the development of its services based mainly on the optimization of its capabilities and technical resources.

This laboratory dedicated to pharmaceutical packaging will provide the manufacturers in this sector with means, testing equipments and a trained staff that has been trained by ITENE, to control all the quality parameters required and verify packaging compliance for pharmaceutical use with the applicable regulations namely the European Pharmacopoeia and the U.S. legislation such as the U.S. Pharmacopeia and FDA ….

This half-day will be led by an ITENE expert who will present the Good Manufacturing Practices for pharmaceutical primary packaging, as well as requirements on packing and packaging in the procedure for Marketing Authorization (AAM). Indeed, because of the provisions covered by Community legislation on medicinal products, any AMM dossier must include a section reserved for the description of the packaging of the pharmaceutical product. The Marketing authorization procedures of drugs in Tunisia will also be presented by the Ministry of Health.

It should be noted that the establishment of the testing laboratory for pharmaceutical packaging within Packtec was accompanied by technical assistance in the field of pharmaceutical packing and packaging, within the framework of the Tunisian-Spanish cooperation project. This project allowed also, the transfer of know-how and expertise developed within the ITENE in this field.

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