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ISO proposal for the creation of a new technical committee on "Pharmaceutical preparation machinery"

ISO proposal for the creation of a new technical committee on "Pharmaceutical preparation machinery"

 

ISO proposal for the creation of a new technical committee on "Pharmaceutical preparation machinery"

 

The national standards body of China (SAC) proposes to ISO the establishment of a new technical committee on “Pharmaceutical preparation machinery”.

 

The scope of the proposal is standardization of pharmaceutical preparation machinery, including terminology, classification, requirements (including materials requirements, safety requirements, quality requirements and cleaning and disinfection requirements) and test methods of different types of machines and equipments.

 

With the rapid development of pharmaceutical industry in the world and the emergence of innovative drugs, the volume of international trade of pharmaceutical preparation machinery has increased sharply. At the same time the lack of unified standards creates barriers to international trade with this kind of equipment. Quality of pharmaceutical production is directly related to human life and health. Therefore, quality of machinery used for pharmaceutical purposes is of a crucial importance.

 

The technical committee will develop international standards to ensure the safety requirements for producing pharmaceuticals and to improve the technical requirement related to technology level of products, environment protection and personnel safety.

 

In case of national interest, BDS can approve the creation of ISO/TC on Pharmaceutical preparation machinery. If the establishment of ISO/TC is accepted by the national standards bodies – members of ISO, Bulgaria can obtain P- or O-membership in the work of the newly established committee.

 

The national stakeholders can provide their position on the proposal for this new field of ISO technical activity and BDS participation in standards making process by 25 of July 2016 to eng. Maya Duganova, email: maya.duganova@bds-bg.org, tel. +359 2 81 74 510.

 

For more information about the proposal see: here

19 May 2016