Search results for " inspection" in Articles / App Notes
Article
Prepare for an FDA Bioburden Inspection
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Not sure how to best approach a bioburden problem when an FDA inspection is imminent? Anastasia Lolas, former FDA Biologics License Application (BLA) revi…
Article
Prepare for an FDA Bioburden Inspection
A best-practices response will not only help you be prepared for any upcoming FDA inspection, it may also yield valuable insights to help improve processes and procedures. Anastasia Lolas, former FDA …
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Inspect Your Chromatography Column to Ensure You Get It Right
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Have you ever seen bubbles in the resin bed of your chromatography column? Or even space between the resin bed and the adaptor?
This is a sign that something …
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Regulatory Challenges in the QbD Paradigm
It's no wonder that "Supply Chain Management," "Accountability in a Global Environment," "Foreign Inspections," and "International Compliance" were some of the key sessions at the 2011 PDA/ FDA Joint …
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Evaluating Surface Cleanliness Using a Risk-Based Approach
…al method qualification, surface sampling and recovery testing of the sampling technique, and visual inspection performed during the cleaning validation. Each element of the justification needs to be…
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A Look Ahead at BioPharma Manufacturing and Regulation
Starting in 2014, inspections will use risk-based methodologies. What factors will the agency use to determine whether and when to inspect a foreign facility?
FDA: We have yet to finalize the r…
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Innovative Therapies Require Modern Manufacturing Systems
…llotted to ensuring the accuracy of genetic tests important to precision medicine, expanding foreign inspections of high-risk operations, and supporting orphan drug development. The funding bill furt…
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The Metrics of Quality Culture
This culture welcomes inspections and views these inspections as another tool to use in their continual improvement initiatives. Metrics that could potentially be used to measure a healthy quality cul…
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Cleaning of Dedicated Equipment: Why Validation is Needed
Recent inspection results show that lack of cleaning validation related to the maximum campaign length is still an issue that is worth clarifying. During an inspection of a dedicated manufacturing fac…
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Global Expansion Shapes Drug Oversight
In addition to conducting more inspections and oversight of foreign manufacturers, FDA is working with international organizations to communicate its policies and standards more clearly and to enhance…