Building off a previous revision in 2007, the European Commission on Thursday released its latest update to its guideline on manufacturing sterile drugs.

The Commission said its updated 58-page Annex 1, which provides technical guidance on the principles and guidelines around sterile drug GMPs, follows the recommendation of the GMP/GDP Inspectors Working Group and the PIC/S committee to reflect changes in both regulatory and manufacturing.

“The new guideline should clarify how manufacturers can take advantage of new possibilities deriving from the application of an enhanced process understanding by using innovative tools as described in the ICH Q9 [quality risk management] and Q10 guidelines [quality systems],” the commission explains. “The revision of Annex 1 should also take into account related changes in other GMP chapters and annexes as well as in other regulatory documents. The revised guideline will seek to remove ambiguity and inconsistencies and will take account of advances in technologies.”

The guideline that will take effect in one year — August 25, 2023 — details requirements for manufacturers’ quality systems, which should “ensure that all activities are effectively controlled so that the risk of microbial, particulate and endotoxin/pyrogen contamination is minimized in sterile products.”

It also goes through the intricacies of cleanrooms and clean air equipment, as well as how to disinfect cleanrooms, and how personnel should be trained.

The bulk of the guidance focuses on production and technologies, offering specifics on various terminally sterilized products, aseptic processes, sterilization (via heat, moist heat, dry heat, radiation and ethylene oxide) processes, as well as Form-Fill-Seal and Blow-Fill-Seal equipment, lyophilization (freeze-drying), and single-use systems.

“This Annex provides general guidance that should be used in the design and control of facilities, equipment, systems and procedures used for the manufacture of all sterile products applying the principles of Quality Risk Management (QRM), to ensure that microbial, particulate and endotoxin/pyrogen contamination is prevented in the final product,” the commission explains.

The guideline also notes that although the intent of the Annex is to provide guidance for the manufacture of sterile products, some of the principles and guidance, such as contamination control strategy, design of premises, cleanroom classification and others, “may be used to support the manufacture of other products that are not intended to be sterile such as certain liquids, creams, ointments and low bioburden biological intermediates, but where the control and reduction of microbial, particulate and endotoxin/pyrogen contamination is considered important.”

PIC/S chair Paul Gustafson said in March that this revision is “much more comprehensive” than the current Annex 1, and will have a “wonderful impact on aseptic processing and protection of patients,” as well as a “significant improvement over the current version and highlights the tremendous collaborations between PIC/S, EMA and WHO.”

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