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ANSI Seeks Comments on New ISO Field of Activity on Pharmaceutical Preparation Machinery

Feedback due by June 24

05/05/2016

The International Organization for Standardization (ISO) has circulated a proposal for a new field of activity on pharmaceutical preparation machinery. As the U.S. member body to ISO, the American National Standards Institute (ANSI) invites all relevant and interested stakeholders to submit comments on the proposal by the end of the business day on Friday, June 24, 2016.

The proposal details intentions to develop international standards for preparation machinery in order to meet the needs of international trade of preparation machinery manufacturers in various countries. It also explains that preparation machinery, as the primary machinery for drug production, directly affects the safety and quality of pharmaceutical production. However, due to differences in the level of science and technology and industry, requirements for the safety and quality of pharmaceutical preparation vary depending on country and region.

As a solution, international standards of pharmaceutical preparation machinery will benefit consumers, who will gain access to pharmaceutical preparation machinery with reliable quality and security. The standards will also help manufacturing enterprises and small and medium enterprises to improve the technical level of product and increase exports.

The Standardization Administration of China (SAC) submitted the proposal, and should the proposal succeed, China is willing to undertake the work of the Secretariat of the new ISO Technical Committee (TC).

All interested stakeholders are invited to review the proposal, which includes related standards and a listing of relevant countries where the subject of the proposal is important to their national commercial interests. Please submit comments to Steven Cornish, ANSI senior director of international policy (scornish@ansi.org), by close of business on Friday, June 24, 2016. Based on the input received, the ANSI ISO Council (AIC) will then be asked to approve an ANSI position and comments to be submitted to ISO before its August 5, 2016, deadline for voting on the proposal.

ANSI has published an explanatory information document outlining the process used to develop U.S. positions on issues and activities under consideration by ISO and IEC.

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