Drugs

Comments on ICH Quality Risk Management Guidance

Pharmaceutical Research and Manufacturers of America (PhRMA) says it generally supports the International Council for Harmonization (ICH) Q9(R1) draft guidance on quality risk management and recommends several revisions for clarity. “We support revision of the Q9 quality risk management guidance and FDA’s efforts to help facilitate more effective and science-based control strategies, improve manufacturing consistency, and lower the likelihood of quality defects, recalls, and medicine shortages,” the PhRMA letter says. “International harmonization through ICH is particularly important because it helps ensure alignment among ICH member regions, preserves efficiency in pharmaceutical development and manufacture, and speeds patient access to medicines.”

The Association of Clinical Research Organizations (ACRO) says the draft “provides a much-needed perspective in order to support the industry in adopting quality risk management practices. The draft does an excellent job of highlighting the core expectations and key operational process components of quality risk management.”

ACRO suggests that ICH “make a strong statement to emphasize the scope of the guidance. There is general consensus within the industry that the guidance mostly applies to manufacturing, but the scope section clearly indicates that it also applies to the development process as well. We believe that this point should be strengthened and reiterated….”

Line-by-line specific comments were submitted by Organon, Bayer, and the Parenteral Drug Association.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome