Search results for " inspection"
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Modern Manufacturing Systems Key to FDA Quality Initiative
Quality data key
Science-based standards for application review and plant inspection support this approach by communicating clear expectations for industry. Such standards will aim to capture criti…
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Pandemic Alters Policies and Practices for Drug Development and Regulation
At the same time, curbs on FDA inspections to evaluate manufacturing sites during the pandemic prompted regulators to expand their use of alternative oversight methods. FDA officials relied more on pa…
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FDA Seeks Metrics to Define Drug Quality
To further encourage quality production, FDA seeks to establish clear, written, clinically relevant public standards that it can enforce through review and inspections. This effort is supported by the…
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Regulatory Requirements for Safe and Efficient Biologic Drug Development
Basically, as you're getting ready to submit for a preapproval inspection from FDA, the EU, whoever it may be, whatever regulator—look at it from the lens of a regulator. Put yourself in a regulator's…
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Drug Quality Key to Innovation and Access
A growing collaboration involves GMP inspections of APIs by FDA and regulatory authorities in Europe, Japan, Australia, Canada, and by the World Health Organization (WHO). FDA and the European Medicin…
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Quality Systems Key to Lifecycle Drug Management
Field inspection is not connected to knowledge gained from product review, and there can be a significant disconnect between clinical batch data and commercial production.
CDER’s new Office of Pharm…
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Framing Biopharma Success in 2016
While this faster route to market of needed therapies is good news, FDA’s inspection process, and the inability of drug manufacturers to accelerate production timeframes, are potential roadblocks. Joh…
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Breakthrough Drugs Raise Development and Production Challenges
…ust manufacturing processes, clinical or commercial site production, site readiness for pre-approval inspection, deferral of Phase III studies to post approval, and the need for comparability protoco…
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Quality Considerations for Using AI in Bio/Pharma
…re applying it to process development … It is something that can get inspected, so be ready for an inspection,” Schmitt cautions.
Susan J. Schniepp, distinguished fellow at Regulatory Compliance …
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ISPE Releases Cleaning Validation Guide
…ndustry,” said Jose Caraballo, head Audit Program Management Americas, Corporate Quality Audit and Inspections, Bayer US, Guide co-lead, in the press release. “We decided to address the topic because…