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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

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    We are concerned that the email function for this group within the PDA Workspace may not be functioning properly.  If you receive this message, please confirm by replying to me directly at rmiller@pda.org.  Thank you. Kind regards, Ruth ------------------------------ ...

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    Commenting Tracker Update 2019-03-06

    The attached commenting tracker includes updates made during this morning's Comment Triage Team call.  I've also added a column to the far right of each sheet to track the most recent update/input to each line. ------------------------------ Ruth K. ...

  • The agenda is attached. We also will be referring to the most recent version of the commenting tracker, which I sent out on Friday, March 1. I look forward to speaking with you then. ------------------------------ Ruth K. Miller, JD PDA Director of ...