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PDA Standards Development

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.

ANSI logoPDA 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. Therefore, the logical and natural progression was for PDA to expand this expertise into the world of creating standards that provide guidance to the industry on best practices for drug manufacturing for patient use.

 
 

The PDA became a Standards Developing/Development Organization (SDO) through the American National Standards Institute or ANSI for short. 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. These principles mean: anyone who wants to contribute can, no one group can monopolize or skew procedures in its favor, and, should someone feel that he or she wasn’t given proper consideration, procedures are in place to review and evaluate the situation to ensure the process was conducted fairly and equally.

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 (https://www.ansi.org/essentialrequirements). 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.

The PDA Standards Development Process

 
 

How is ANSI related to ISO?

ISO logoAnother advantage in becoming an ANSI-accredited Standards Developer and having approved standards through ANSI is that the voluntary consensus standards are produced in a process consistent with that of the International Organization for Standardization (ISO).

ANSI is the sole U.S. representative of ISO, and a founding member; hence, ANSI plays an active role in ISO governance. ANSI has also been a strong and active leader in ISO’s sister organization, the International Electrotechnical Commission (IEC), as well as other international and regional standardization bodies. By being accredited through ANSI, PDA has the opportunity to also participate in ISO standards development.

Want to Be a Part of Standards Development Process and Know More?

Membership in any PDA standards development activity is open to everyone, particularly those that may be interested or involved in production, application, and regulation of products related to the pharmaceutical, biopharmaceutical, scientific, and regulatory community. You can learn more by contacting [email protected] and make sure to visit the Frequently Asked Questions page.

 
 

Current Standards Activity

 

New Standard Initiatives

 
  • BSR/PDA Standard 07-201x, Analytical Method Development and Qualification for Biotechnology. Products. Dr. Stephan Krause (Chair)
 

Standards in Development

 
  • BSR/PDA Standard 02-201x, Cryopreservation of Cells for Use in Cell Therapies, Gene Therapies, and Regenerative Medicine Manufacturing: An Introduction and Best Practices Approach on How to Prepare, Cryopreserve, and Recover Cells, Cell Lines, and Cell-Based Tissue Products. Brian Hawkins (Chair), Kathy Loper (Co-Chair)
  • BSR/PDA Standard 03-201x, Standard Practice for Quality Risk Management of Aseptic Processes. Noel Long (Chair), Amanda Bishop- Mcfarland (Co-Chair)
  • BSR/PDA Standard 05-201x, Consensus Method for Rating 0.1 Mycoplasma Reduction Filters.  Martha Folmsbee (Chair), Kathleen Souza (Co-Chair)
  •  BSR/PDA Standard 06-201x, Quality Culture Assessment Tool. Susan Schniepp (Chair), Althea Micklewright and Jeff Broadfoot (Co-Chairs)
 

Standards Completed

 
  • ANSI/ PDA Standard 001-2020:, Enhanced Purchasing Controls to Support the Bio-Pharmaceutical, Pharmaceutical, Medical Devices and Combination Products Industries. Martin Van Trieste (Chair), Sue Schniepp (Co-Chair)
  • ANSI/PDA Standard 04-2021, Phage Retention Nomenclature Rating for Small and Large Virus Retentive Filters. Duncan Low (Chair), Scott Lute (Co-Chair)
 
PDA Standards Policies and Procedures