The Annex 1 revision process continues and the document is expected
to be out soon. Although, according to Andrew Hopkins,
Expert GMDP Inspector, UK MHRA, in his talk at the opening
session of the 2017 PDA Annex 1 Workshop on Oct. 2 in Washington,
D.C., he did not have a time frame for when the document
would be available.
Hopkins’ presentation provided extensive coverage of the reasons
behind the revision. In his words, EMA recognized the document
needed “tidying up.” The revision is expected to include Quality
Risk Management (QRM) principles and address the need for
manufacturers to keep up with new technologies.
Additionally, the revised Annex 1 will keep the requirement that
manufacturers conduct pre-use, post-sterilization integrity testing,
commonly referred to as “PUPSIT.”
Gabriele Gori, VP, Head of Quality Audit and Risk Management,
GSK Vaccines, and Hal Baseman, Chief Operating Officer, Val-
Source, currently head the PDA task force looking into the Annex
1 revision and working closely with European regulators. Members
of this task force published the two-part Points to Consider for Aseptic
Processing document in 2015 and 2016 in advance of the Annex 1
revision. Both Part 1 and Part 2 can be purchased from the PDA Bookstore.