PDA: Standards Development Process
The Parenteral Drug Association (PDA) is an international, non-profit trade group providing science, technology, and regulatory information to the pharmaceutical and biopharmaceutical community. As a leader in the industry, PDA is accredited through the American National Standards Institute (ANSI) as a Standards Development Organization (SDO) to develop voluntary consensus standards for pharmaceutical and biopharmaceutical product manufacturing practices.
PDA Technical Committees and Advisory Boards
PDA carries out its standards development work through technical committees (also called technical teams or working groups) that address particular technological areas within a defined scope of work. Proposals for new standards are first evaluated by PDA Advisory Boards (ABs) and reviewed by ANSI to check against existing or overlapping initiatives prior to the formation of the technical committees by the ABs.
PDA Advanced Therapy Medicinal Products Advisory Board (ATMP AB)
Provides guidance and strategic direction on cell, gene, tissue, and other novel therapeutic modalities.
PDA ABs evaluate proposed standards within five topic areas:
Aseptic Processing & Sterilization
Biopharmaceuticals & Biotechnology
Manufacturing Science
Quality & Regulatory
Supply Chain & Outsourcing
Standards Development Process
The PDA standard development process has seven major steps:
Initiating the Project: A new standards development activity is initiated, and the responsible PDA AB appoints a chair or co-chairs.
Working Group Formation: A working group is formed from volunteers across diverse stakeholder communities through invitation or application.
Drafting the Standard: The working group develops a draft standard.
Internal Review: The draft document is reviewed by the responsible AB and stakeholders are balloted.
Public Comment: A 45-day public review and commenting period is initiated.
Finalization: The technical committee responds to comments, resolves differences, and notifies unresolved objectors of their rights to appeal.
Publication: The document is either published as a PDA standard or sent for additional rounds of re-work.
How You can Participate in PDA Standards Development
Membership in PDA is not a requirement to join a PDA working group. Interested parties can seek inclusion in a PDA standard development working group as an individual or representative of an organization by applying through the PDA Scientific and Regulatory Affairs (S&RA) office.
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Learn more about how SCB works with SDOs