PDA Standards Development

In a heavily regulated industry, it is imperative to follow accepted rules, guidelines, and ways of doing things to improve processes and reduce regulatory risk.

A standard is established by consensus and provides rules, guidelines, or characteristics for activities or their results. Implementing standards enables organizations to streamline processes, reduce costs, gain and maintain market access, and boost their bottom lines.

PDA has been accredited as a standards developing organization by the American National Standards Institute (ANSI) since 2017. PDA’s standards program focuses on documentary standards, building on the existing rigorous, volunteer expert-driven scientific process used to develop PDA’s technical reports.

Why Have Standards

Standards serve a very important purpose and are a part of our daily lives − in the lab where our samples are tested, in the equipment that we use at the gym, to the way we work and perform our jobs. We need them to help keep us safe, to make sure that there is consistency in how products are made, tested, and used by all, and sometimes the government may mandate compliance with a standard in lieu of government guidance. Standards benefit everyone too—industry, government, consumers, young professionals, and students.

PDA is recognized by industry professionals and regulators around the world who rely on PDA’s peer-reviewed technical documents for expert guidance and opinions on important scientific and regulatory topics.

The PDA became a Standards Developing/Development Organization (SDO) through the American National Standards Institute (ANSI). ANSI is a private, non-profit 501(c)(3) organization whose mission is “to enhance both the global competitiveness of U.S. business and the U.S. quality of life by promoting and facilitating voluntary consensus standards and conformity assessment systems and safeguarding their integrity.” ANSI does make it easier to come to an agreement by accrediting the procedures used by standards developers, and by making sure that these procedures allow for openness, balance, consensus, and due process.

Approval of a PDA standard as an American National Standard (ANS) means that the standard meets ANSI’s Essential Requirements and the Federal government’s definition of a Voluntary Consensus Standard per OMB A119, and the World Trade Organization (WTO) Technical Barriers to Trade (TBT) Code of Good Practice (CGP) criteria for openness, transparency, impartiality and consensus, relevance and effectiveness.

PDA Standards are Intended to be Scientifically Derived Technical Standards. Examples Include:

• Material quality standards – this may describe tests, specifications, or data conversion on specified materials.
• Universal Process & procedure standards – This may be an agreed upon processes in the industry or agreed upon way of doing something.
• Format or Referencing standard – This could be an agreed upon list of definitions, nomenclature, or data formats to facilitate global harmonization in scientific language.
• Measurement/ Metrology standards - Supports harmonization in equipment use, statistical calculations, and formulas.

Becoming an accredited Standards Developer means that the process and steps performed by PDA meet the guidelines set forth by the American National Standards Institute (ANSI) in the ANSI Essential Requirements: Due Process Requirements for American National Standards. The key elements include openness, consensus vote, due process, lack of dominance, balance, public review/consideration of views and objections, an appeals process, and compliance with the ANS policies and administrative procedures.

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