Gap Analysis Critical for Combination Product cGMPs

To comply with FDA’s combination product good manufacturing practices, both devicemakers and drugmakers should first look at their systems and conduct a gap analysis using both the quality system regulation and drug cGMPs. Read More

FDA Hits 3 Duodenoscope Makers With Warning Letters

Olympus is facing tough questions from the FDA following inspections conducted in April and May of four facilities that manufacture duodenoscopes. The company — along with Pentax and Fujifilm — is facing scrutiny after improper cleaning of its complex endoscopes was linked to patients becoming sick or dying. Read More

Report Details Risk Management Needed to Conform to EU’s MDD, Annexes Z

Before manufacturers complete their risk-management processes, they should perform a risk-benefit analysis for any risks that are unacceptable under Annexes Z in EN ISO 14971: 2012, and for which further risk reduction is possible, according to a draft consensus paper from the EU-based Notified Body Recommendation Group. Read More