The Parenteral Drug Association (PDA) have released its comments to the European Medicine Agency’s revision of GMP Annex 1: Manufacture of Sterile Medicinal Products. The Association credited EMA for the tremendous effort it put forth revising the Annex to integrate new concepts and to facilitate the introduction and implementation of innovative technologies.

“EMA tackled a wide range of complex topics with some excellent and much needed improvements,” said PDA President Richard Johnson.

“One area that stands out is the emphasis on risk-based thinking and decision making throughout the revision,” said PDA Europe General Manager and Vice President Falk Klar.

The commenting task force of PDA volunteers began preparing to comment on the draft revision since 2016 and moved immediately to draft the Association’s response when the document was published for public consultation last December. The comments were reviewed and approved first by PDA’s volunteer Science Advisory Board and then its Board of Directors.

As part of its “General Comments,” PDA asks EMA to provide more explanation of expectations and guidance with respect to risk management to assist those tasked with making process-control-related decisions to avoid the misuse or ineffective use of risk-based approaches.

PDA also recommends that EMA completely revises Section 8.84 of the draft on the pre-use, post-sterilization integrity test (PUPSIT) for sterilizing filters. PDA strongly suggests a well-documented, risk-based assessment of the actual control strategy implementation to address potential filter and device assembly defects and filtration failures caused during manufacture by mishandling, etc., to determine whether PUPSIT might be needed to increase the sterility assurance of the process.

Following a brief cover letter, the PDA comments are set up in an easy-to-use table with “General Comments” first and then section-by-section recommendations.