Pharmaceutical Standards Development

  • Overview
  • Benefits of Standards Development
  • Why Work With NSF?

NSF has developed more than 50 voluntary American National Standards to promote public health and safety, the latest of which focus on pharmaceuticals. NSF/ANSI standards are developed through involvement of stakeholders affected by the standard. The process ensures balanced input from industry representatives, public health/regulatory officials, users/consumer representatives and other relevant interest groups.

NSF is accredited by the American National Standards Institute to develop American National Standards. As an audited designator, NSF has authorization from the ANSI Executive Standards Council to designate its standards as ANSI standards without review and approval by the ANSI Board of Standards Review. ANSI accreditation verifies that NSF develops standards to ensure openness and due process allowing for equity and fair play.

For standard development or revision status, visit the NSF Online Workspace. Get involved with NSF standards and protocol development by joining a Joint Committee. The NSF Standards Department is seeking experts to serve on various NSF joint committees. Learn more.

To purchase standards, visit the NSF Bookstore website.

Benefits of Standards Development

NSF recognizes the important role pharmaceutical companies should play in the development of any new pharmaceutical standard. Participating in the standards process or becoming an NSF Joint Committee member are important ways to ensure standards reflect the needs of all stakeholders and the public.

How to Participate in Developing or Revising an NSF Standard

ANSI requires accredited standard developers to provide public notification of every standards project, and publishes this information in Standards Action under Project Initiation Notification System (PINS). By monitoring PINS, which includes project scope and contact information, you can track standards under development or revision.

You can participate in creating or revising a standard in many ways:

  • Joining a joint committee, the consensus body responsible for development and revision of NSF/ANSI standards
  • Joining a task group that provides recommendations to the responsible joint committee on a specific issue
  • Attending joint committee or task group meetings as an observer
  • Submitting public review and comments through ANSI
  • Submitting an issue document to suggest revision to an NSF/ANSI standard

ANSI requires a public review period for all proposed standards in Standards Action. Drafts are announced under Call for Comments and revisions under Final Actions.

What is an NSF Joint Committee?

NSF joint committees, consisting of public health, industry and user members, are consensus bodies responsible for:

  • Proposing NSF standards consistent with NSF's mission
  • Voting on approval of proposed NSF standards
  • Ensuring standards properly address public health, safety and environmental issues
  • Responding to requests for interpretations of NSF standards

A unique feature of the NSF process is the review of all standards by the NSF Council of Public Health Consultants.

What is the NSF Council of Public Health Consultants?

The NSF Council of Public Health Consultants is composed of representatives of professional organizations, federal and state regulatory agencies, and academic institutions as well as nationally or internationally recognized individuals who have demonstrated leadership in the public health and environmental fields. The council provides advice to NSF by:

  • Developing standards to serve the protection of public health
  • Reviewing and balloting all new standards and revisions of existing standards
  • Chairing specific joint committees to provide a liaison between the council and joint committees

Why Work With NSF?

Key to the success of any new standard is ensuring balanced input from industry representatives, public health/regulatory officials, users/consumer representatives and other relevant interest groups around the globe. NSF ensures that all 50 NSF/ANSI standards are continuously reviewed and revised to meet the latest technology and industry practices.

NSF's extensive global expertise, working with diverse groups in the development of voluntary consensus standards, means you can feel confident from day one when seeking to develop a new standard with NSF.

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