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Biopharmaceuticals and Biotechnology

PDA News

Standards at PDA

by Christine Alston-Roberts, PDA | Nov 05, 2018

Adding to Our Growing Portfolio of Technical and Scientific Work

PDA was accredited as a standards development organization in March 2017 by the American National Standards Institute (ANSI). ANSI coordinates standards, conformity assessments and related activities in the United States; they are the official U.S. representative to the International Organization for Standardization (ISO). An American National Standard (ANS) is a voluntary consensus standard, where all materially affected and interested stakeholders, including consumers and the general public, have a voice in the ANS process.

Accreditation by ANSI means meeting the due process-based criteria established in the ANSI Essential Requirements document. Key components include:

  • Consensus is reached by representatives from materially affected and interested parties
  • Proposed standards undergo public reviews where any member of the public can submit their comments
  • Comments are responded to in good faith
  • A required appeals process is available

Standards can be generally categorized into documentary standards and reference materials. PDA’s standards program will focus on documentary standards. As such, the program will build upon the existing rigorous, volunteer expert-driven scientific processes used to develop PDA’s technical documents. Forthcoming PDA standards will follow a very similar path as technical reports (Figure 1). PDA’s Board of Directors will provide strategic oversight of proposed standards, ensuring standards align with strategic objectives (Figure 2). At the next level, the PDA’s advisory boards that approve all technical documents will also approve standards. A task force, here referred to as a “consensus body,” will be developed comprising experts and stakeholders in the field. Outside input will also be considered.

Standards_fig1
Figure 1 Development of a Standard versus a Technical Report
Standards_fig2
Figure 2 Standards Governance

Existing PDA materials will be used to develop standards along with new information. For example, a standard could be developed as the result of a technical report revision, either replacing the technical report or serving as a companion to the document. While individuals both within and outside the PDA membership can propose a new standard, the vetting process will carefully consider how a proposed standard fits within PDA’s mission, such as how the standard would or could be used in a conformity assessment or compliance context. Once endorsed by an Advisory Board, a standards proposal will be sent to ANSI to be checked against other proposed and existing standards, and an open public comment announcement is made for 30 days. This is actually an open call for volunteers to form the consensus body. That group will draft the standard.

Figure 3 shows the general development process for a PDA standard: An expert task force is formed, a draft document is created, the working draft is then delivered to reviewers and the final draft is presented to the Advisory Board and Board of Directors for balloting. Once approved by the Board of Directors, the standard is then finalized for publication and presented to the ANSI executive standard council for review and approval to become an ANS. A 60-day open call for volunteers to serve on the consensus body is made following a new standard announcement.

Standards_fig3
Figure 3 Approximate Standard Development Steps and Time Line

An important additional step in the standards development process is an open public comment period, in accordance with ANSI rules. Once comments are received, they are deliberated for resolution before the standard is put forward for a consensus vote.

Two Standards Already in Pipeline

PDA’s new standards program is already off the ground and running with two projects that have successfully completed the ANSI proposal stage and final team formation is in process. Both proposals are for new standards and address key industry concerns:

BSR/PDA Standard 01-201x, Enhanced Purchasing Controls to Support the Bio- Pharmaceutical, Pharmaceutical, Medical Devices and Combination Products Industries: The proposed standard is intended to address the challenges faced when purchasing, procuring or referencing where specific materials or ingredients came from. This proposal also provides steps to make the responsible party more effective in preventing substandard or adulterated materials from entering the market and potentially harming patients.

BSR/PDA Standard 02-201x, Cryopreservation of Cells for Use in Cell Therapies and Regenerative Medicine Manufacturing: The proposed standard is intended to address the challenges associated with maintaining viable recovery and functionality of cellular therapies and tissue products, discuss the benefits and considerations of low-temperature biopreservation, outline biopreservation best practices for users and propose considerations for incorporating biopreservation best practices into GMP for cell therapy products.

Look for updates on our website as these standards are developed and posted for public comment. You can learn more and get involved by contacting the Standards Manager.

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