Behind the Revision: Points to Consider for Aseptic Processing

PDA strives to provide the industry with relevant and meaningful guidance in our technical publications.?To keep up with the ever-increasing change in the pharmaceutical industry, we are announcing the publishing of an important revision to the Points to Consider (PtC) for Aseptic Processing, Part 1 and Part 2.

In anticipation of the impact of the implementation of the new revision of The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinarian Use, commonly referred to as “EU Annex 1” (also adopted by PIC/S), PDA formed a Science Advisory Board (SAB) taskforce to perform a targeted review of PDA technical documents related to topics covered in the Annex 1 revision.

The goal was to verify if these PDA documents were in alignment with the new regulatory guidelines or if updates were needed. Our approach to our technical documents is to provide guidance that is firmly based on scientifically backed principles. When divergence between this approach to our recommendations and that of any regulatory agency occurs, PDA makes great efforts to identify and clarify what the science reveals and what the regulations require.

The purpose of this targeted review on the PtC for Aseptic Processing documents was no different. The review focused on updating and aligning the recommendations provided in the PtC documents, where applicable to the EU/PIC/S Annex 1 guidelines, and to note if and where PDA positions might differ. This allows PDA members to have the fullest knowledge possible to guide their Annex 1 implementation decisions. By having a targeted review of the documents, the revision and republication process was greatly expedited allowing for a timely release of this necessary guidance document at roughly the same time as the EU Annex 1 implementation requirement date.?

After the initial review was conducted by the SAB taskforce, it was determined that the Points to Consider should be revised by a team selected from the initial Annex 1 expert taskforce.??

The Annex 1 Targeted Review Taskforce modified recommendations but did not add or delete any full sections of the two PtC documents. These two revised PtCs were then combined into a single reference document. This combined version reflects concerns raised at meetings and workshops by industry professionals, technology developers, and regulators on the required solutions to meet the challenges of modern aseptic processing.

The new iteration of the document includes additional clarification and improved guidance on topics such as the operation of and intervention control regarding barrier systems. Details on how to design an effective aseptic personnel qualification program are also provided in this version. Novel topics not previously addressed will be considered for inclusion in a future PtC or technical document.

The Points to Consider for Aseptic Processing Part 1 (revised 2015) and Part 2 (published 2016) revision was just published as a combined document titled Points to Consider No. 1: Aseptic Processing (Revised 2023). The Annex 1 Targeted Review Taskforce completed this document revision in record time as a result of their dedicated effort and the support of the PDA Science and Regulatory Affairs team.

A special thanks to the Annex 1 Targeted Review Taskforce!