Search results for " compliance"
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State of Quality and Compliance in the Biopharmaceutical Industry
The following years witnessed FDA's launching of multiple initiatives in an attempt to inspire the industry to achieve higher standards of quality and compliance. Among these initiatives are the Pharm…
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Good Manufacturing Practices: Challenges with Compliance
Obstacles to compliance
BioPharm: What challenges do you see in complying with FDA’s CGMP regulations for biopharmaceutical manufacturing?
Smith (Catalent): In general, it is not difficult t…
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Gowning Practices Provide Clues to cGMP Compliance
In existing legacy facilities and as buildings age, however, ensuring compliance with cGMPs is more complicated. A review of a facility’s gowning operations can bring significant insight into the curr…
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Operational Excellence: More Than Just Process Improvement
In addition to increased efficiency and cost reduction, there is a third leg to the stool: quality and compliance benefits. With carefully designed, executed, and sustainable operational excellence pr…
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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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Assessing Manufacturing Process Robustness
It is performed in the following two parts:
Part A involves a holistic regulatory compliance review solely focusing on the compliance with the lifecycle-associated lifecycle regulat…
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FDA Seeks Metrics to Define Drug Quality
FDA is seeking new strategies to spur compliance with GMPs and to limit drug production errors that lead to supply problems, Woodcock explained at a July 10, 2013 seminar on “Understanding cGMPs” spon…
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Using Software in Process Validation
Validation must happen at each step of a manufacturing process, which involves lots of team members from engineers to quality control to compliance officers, etc. to ensure that the finished product m…
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CoAs Help Secure the Supply Chain
Schniepp, distinguished fellow at Regulatory Compliance Associates
Damian Palus/Shutterstock.com
Q. I work in the warehouse and am responsible for maintaining the pape…
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GMP Challenges for Advanced Therapy Medicinal Products
Academics seeking to arrange preclinical and clinical trials for their innovations are so concerned about the complexities of compliance with GMP that they try to avoid having them classified as ATMPs…