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ANSI/PDA Standard 001-2020
Enhanced Purchasing Controls To Support The Bio-Pharmaceutical, Pharmaceutical, Medical Devices And Combination Products Industries

PDA, accredited by ANSI as a Standards Developing Organization, is pleased to announce the release of its first Standard, available for purchase in the PDA Bookstore.

This new Standard seeks to ensure that there is an awareness of the requirements for purchasing controls for a specific material, component, product, or service throughout the product lifecycle and that the responsibility for compliance at all stages is shared throughout the entire organization, with final responsibility falling to the management of the company.

The need for risk-based processes and an independent Quality Unit are discussed, and recommendations for specific procedures are outlined.

This Standard is intended to expand on the requirements already defined under FDA regulations and should be viewed only as recommendations.

As a non-member of PDA, you can purchase this document for $325 at any time.

      Purchase Today      

Or, you can join PDA for $279 and purchase the Standard at a discounted price of $180.

When you become a PDA member, you will also gain on-demand access to view the entire online library of more than 80 peer-reviewed Technical Reports – valued at more than $10,000. See what other exclusive Member Benefits will become available to you.

This is an opportunity you can't afford to pass up!

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As an ANSI accredited Standards Developer, PDA has met the guidelines set forth by ANSI that include openness, consensus vote, due process, lack of dominance, balance, public review/consideration of view and objections, an appeals process, and compliance with the ANSI policies and administrative procedures. Find out more about PDA Standards Development.

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