PDA® Standards Development Call for Volunteers

PDA is very pleased to announce the launch of the Parenteral Drug Association’s third standard!  We are seeking volunteer participants to assist in developing, writing, and fine tuning the following proposal:

 Standard Practice for Quality Risk Management of Aseptic Processes (new standard).

This is a practical standard to guide industry and regulators seeking to apply, or evaluate, Quality Risk Management principles in decisions related to:

  • planning,
  • design,
  • qualification,
  • operation,
  • monitoring, and

investigation of the various aspects of Aseptic Processing.

This proposed American National Standard (ANS) was presented by Mr. Hal Baseman, Chief Operating Officer, ValSource Inc.

Those individuals involved in Quality Assurance, Quality control, Quality Engineering, Operations, Production and Manufacturing, MSAT and Process Development, Engineering and Maintenance, Validation, Regulatory, International Health Authority Reviewers and Inspectors are being sought.

 Nominations/Volunteers to serve as a member of the technical team (consensus body) must have some subject matter expertise, and willing to help write/contribute to this standard. Applicants should apply by contacting the PDA Standards Manager at standards@pda.org.  The deadline to submit notification of interest in serving on the consensus body is March 28, 2019.

Latest Discussions

  • Regulatory Commenting Triage Team -- Welcome to the team, and thank you for volunteering! I'm attaching the most recent version of the Commenting Tracker so that you may familiarize yourself with the format.  Moving forward, the plan is for this team ...