Pharmaceutical manufacturers in the EU may have to approach the manufacturing of sterile drugs a little differently under the EU’s Annex 1 covering good manufacturing practices (GMPs), which goes into effect soon. For example, regulators may be asking to see whether firms have a documented contamination control strategy (CCS) and may require firms to conduct pre- and post-sterilization integrity testing (PUPSIT) on filters used in sterile drug manufacturing.
In the meantime, regulators from the US Food and Drug Administration (FDA) said that while they will not be enforcing Annex 1, inspectors will be looking into similar areas as their counterparts in the EU.
These assertions were made by regulators and members of the pharmaceutical industry from the US and EU at two panel discussions on Annex 1 implementation at the International Society for Pharmaceutical Engineering’s annual aseptic conference in Bethesda, MD this week.
Panelists addressed a range of questions concerning filter testing under PUPSIT, implementation of the new CCS, and whether existing lines should be retrofitted to meet the new requirements of Annex 1…
