Key Areas Revised
• High levels of subjectivity in risk assessments
and in QRM outputs – different stakeholders
have different perceptions for risk
assessments, including very subjective risk
scoring methods
• Failing to adequately manage supply and
product availability risks – despite ICH Q9
not being a supply chain guideline, the
manufacturing of a product, and later its
quality throughout the lifecycle, is affected
by issues in that aspect. Addressing lifecycle
risks to manufacturing reliability and quality
assurance is the foundation for a better supply
predictability
• Lack of understanding as to what constitutes
formality in QRM work – a clarification as
deemed necessary as in what to expect in
terms of degree of formality and flexibility
to apply in QRM activities, as significant
disorientation and uncertainty has been
noticeable in both regulators and industry2 4.
Post a Comment