PDA Survey: 2024 PDA Annex 1: One Year into Implementation Survey

In February 2015 the European Medicines Agency (EMA) and the Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-operation Scheme (PIC/S) jointly issued a Concept Paper on the revision of the EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (1, 2). However, it would take more than 7 years, 2 public revisions (one of which "targeted" selected professional and trade associations), and more than 8000 comments from industry stakeholders, regulators and other interested parties before the approval of the final version by the European Commission in August 2022 (3). During the same period, PDA holistically reviewed and updated its library of technical documents on aseptic manufacturing by revising 2 Points to Consider (PtC) documents which were then merged in a 2023 version (4).

PDA conducted a survey regarding the actual implementation status of the revised requirements. This was done as a follow-up to the numerous discussions held at meetings with the Inspector Working Group in charge of the Annex 1 revision.

The goals of the survey were to verify whether the anticipated challenges had materialized and to identify further initiatives aimed at supporting the industry (and regulators) in the implementation of the underlying principles reported in the Annex. A team of subject matter experts developed 41 key questions, which were reviewed by the PDA Science Advisory Board, to gather meaningful feedback and experiences from the global pharmaceutical industry related to implementation of the revised Annex 1 requirements.