Annex 1 of the PIC/S Good Manufacturing Practise (GMP) Guide on the manufacture of sterile products has been revised and published. The amendment was enforced on 25 August 2023, excluding for Lyophilization procedure (8.123) which soon will be enforced on 25 August 2024.
Lyophilization is an important step also known as freeze-drying which involves 3 processes; freezing, primary drying (sublimation) water removal from a product after being frozen and placed under a vacuum, allowing the ice to change directly from solid to vapor without passing through a liquid phase (FDA).
Point 8.123 of Annex 1 has been postponed for enforcement until 25 August 2024. In this point, the responsible person for the site must ensure the lyophilizers and associated product transfer and loading/unloading areas should be designed to minimize operator intervention. Lyophilizers that are manually loaded/unloaded with no barrier technology separation should be sterilized before each load. While for automated loaded/unloaded systems, or protected by closed barrier systems, the sterilization frequency can be justified and documented as part of the Contamination Control Strategy (CCS). The frequency of lyophilizer sterilization must be determined based on the design and risks related to the contamination system during usage.
Manufacturers related to the enforcement are reminded to ensure the lyophilizer equipment and its procedures must be designed accordingly so the product or material sterility is protected during lyophilization as a way to prevent microbial and particle contamination.
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