Search results for " inspection"

Article Prepare for an FDA Bioburden Inspection
Click here to read the article >> Not sure how to best approach a bioburden problem when an FDA inspection is imminent? Anastasia Lolas, former FDA Biologics License Application (BLA) review…

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 …

Article 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 …

Article 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…

Article 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…

Article Bioterminology: A Guide to the Biopharmaceutical Lexicon
It requires companies to prove that their products are safe before marketing them, extends FDA oversight to cosmetics and therapeutic devices, explicitly authorizes factory inspections, requires stand…

Article 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…

Article 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…

Article 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…

Article 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…

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