PDA Advances Annex 1 Activities with Workshop, PUPSIT Consortium 4 June, 2018

Bethesda, Md., June 4,2018 – The Parenteral Drug Association (PDA) is advancing its activities involving the recent release of the draft revision to EU GMP Guideline Annex 1, the European guideline for sterile medicinal products with a recent in-depth workshop on the topic and the formation of a consortium to address pre-use and post-sterilization integrity testing for sterilizing grade filters (PUPSIT).

PDA’s Europe office hosted “Annex 1: Revision of the EU GMP Guideline” workshop at the Crowne Plaza Dublin-Blanchardstown, Dublin, Ireland, on May 17. The workshop planning committee, led by Gabriele Gori, GlaxoSmithKline, organized the meeting to facilitate open discussion among industry and regulatory representatives.

The latter included Greg McGurk, Senior Inspector, Health Products Regulatory Authority (HPRA), Ireland, and Dr. Beate Reutter, GMDP Inspector, German state of Schleswig-Holstein, who both shared their perspectives on the draft guidance. Over 150 registrants attended the workshop and participated in lively dialogue.

PDA also recently finalized agreement to participate in a consortium with the Biophorum Operations Group (BPOG) on the Annex 1 requirement for PUPSIT, which will bring together the leading biopharma manufacturers to explore the necessity of this stipulation. The consortium will include all major filter suppliers, most major aseptic manufacturers, and the regulatory authorities concerned about the possibility of filter/filter integrity test failures. The program will create three workgroups that will:

• Define an encompassing risk assessment scheme that will locate the conditions necessary to perform and best deploy PUPSIT
• Define known and unknown failure modes and conditions where pre-use failed filters can be masked
• Study protocols to test and examine failure modes to see if they too can be masked
• Conduct filter locking studies of pre-use flawed filters
• Create a harmonized FMEA to include graduated scaled of risk when using PUPSIT
• Create practice statements for the design and use of the system in different areas