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).
Scope
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.
Who Should Apply
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.
Deadline
The deadline to submit notification of interest in serving on the consensus body is March 28, 2019.
Applicants should apply by contacting the PDA Standards Manager at standards@pda.org.