PDA Workshop on EMA Annex1 Revision Draws Discussion of Difficult Topics 13 June, 2017

Bethesda, Md., June 12, 2017 – The Parenteral Drug Association (PDA) today announced the successful completion of its Annex 1 Revision Workshop, which afforded industry a final preview before the revised guidance for aseptic processing GMPs is issued as early as the end of the month. The workshop, held at the Berlin Hilton, precedes the 2nd PDA Europe Annual Meeting.

Andrew Hopkins, MHRA, and Beate Reuter, Landesamt fur Soziale Dienste, offered highlights of the much anticipated revision to open the one-day workshop. They said the revision is thorough and necessary after years of piecemeal changes to the 40-year-old guidance. The guidance will emphasize the need for manufacturers of sterile drug products, which include vaccines and most other biologic therapeutics, to adopt modern manufacturing tools like isolators and single-use systems.

Hopkins stressed that outdated methods that necessitate operators in a Grade A room reach over product are not acceptable modern processes, even if the guidance will not specially forbid the practice. He warned that modern single-use closed systems are not a panacea.

The revised guidance will emphasize quality risk management approaches and remove settle plate averages. It will not remove pre-use post sterilization integrity testing, commonly referred to in the industry as PUPSIT.

Workshop attendees discussed a number of issues related to the guidance. A great deal of time was spent discussing container closure integrity and environmental monitoring. Participants also expressed hope that the US FDA will look to the Annex 1 when it updates its 13-year-old aseptic guide.

PDA President Richard Johnson announced the launch of a PDA survey on best practices in aseptic processing in the pharmaceutical industry. It is available at https://www.surveymonkey.com/r/APsurveyJune2017.