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The World Health Organization (WHO) has issued an updated draft guideline to assist manufacturers establish an effective quality risk management (QRM) system and to help regulators in planning their inspections. The guidance incorporates concepts from the International Council for Harmonization’s (ICH) Q9 (R1) guideline on quality risk management (QRM).

The World Health Organization (WHO) published a draft guidance this month that aims to assist regulators and pharmaceutical companies in integrating environmental sustainability strategies and metrics into pharmaceutical manufacturing.

BALTIMORE – Risk management remains the top reason the US Food and Drug Administration (FDA) investigators cite medical device makers for failing to meet their quality management requirements, according to a top agency official. She emphasized that companies need to treat risk management as an ever-evolving responsibility.

The top observations identified in Form 483 reports from inspections conducted under the recently implemented Quality Management System Regulation (QMSR) include risk management, outsourcing and purchasing, and complaint handling and feedback.

Key changes with the QMSR include a greater focus on risk management, a culture of quality, and lifecycle integration. One of the biggest changes, officials said, is that risk is at the center of quality processes

The European Medicines Agency has finalized its reflection paper on a tailored clinical approach to biosimilar development, revising the wording on when it may waive the need for comparative efficacy studies.

An Iran-linked hacker group called Handala Team has claimed responsibility for an attack that disrupted Michigan-based medical device manufacturer Stryker's Microsoft systems this week. While the company has said the damage from the incident is contained, a cybersecurity expert says it could lead the US Food and Drug Administration (FDA) to reassess its cybersecurity requirements.