Last Month in “The Gold Sheet” LinkedIn Group
This article was originally published in The Gold Sheet
Executive Summary
A recap of recent discussions at “The Gold Sheet” LinkedIn group, and an invitation to join
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Compliance versus Quality
FDA officials have been emphasizing lately that they want the pharmaceutical industry to strive for quality rather than merely try to achieve regulatory compliance.
Janet Woodcock, head of the agency's center for drugs, put it this way at the International Society for Pharmaceutical Engineering cGMP meeting last month in Baltimore: "The focus has been on compliance, not on quality. And I think that's a mistake. Compliance is a means to an end; quality is the end."
So then is the challenge for industry to achieve compliance with the agency's desire for quality? Or would that be a mistake?
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, which goes to the heart of the role of quality in Pharma.
Dedicated facilities, or not – that is the question
The Pharmaceutical Inspection Cooperation Scheme, or PIC/S, has scheduled a seminar in Paris for pharmaceutical inspectors called “Dedicated Facilities or Not.”
Which raises the question: What is happening on the issue of dedicated facilities? This is one that always seems to be accompanied by a certain amount of hand-wringing and gnashing of teeth. Is there settled guidance on the topic? Is everyone clear on what the rules are in the U.S., Europe, and globally? This is an area where regional differences seem to pose challenges for global manufacturers.
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, which among other things explores the likely direction of EU guidance.
Quality: A necessary evil?
A recent survey of medical device executives found that 20% view quality assurance and regulatory affairs as a “necessary evil.” Asked how Pharma would compare, the group explored a range of views on the role of quality organizations, the relationship to cost, the risk of predicting criminal behaviors and a continuing reluctance among management to examine the quality of suppliers.
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