Search results for " guidance" in Articles / App Notes
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
With the most recent FDA (1) and Inter-national Conference on Har-monization (ICH) guidances (2-4) advocating a new paradigm of process validation based on process understanding and control of paramet…
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The Lifecycle Change of Process Validation and Analytical Testing
…ical services director, of Innopharma Labs in Dublin, about the impact FDA's 2011 process validation guidance has had on analytical testing and validation.
CONTINUOUS PROCESS VERI…
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Successfully Moving Regulated Data to the Cloud
Changing working practices and regulations
One example from FDA’s guidance document describes the use of shared login accounts. Previously, shared accounts have been used to conveniently access a r…
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Putting Viral Clearance Capabilities to the Test
The model viruses used, and the number of steps investigated for viral clearance capacity, should be related to the risk assessment and product-specific regulatory guidance, says Horst Ruppach, direct…
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Transformative Medicines Challenge FDA and Manufacturers
…ce on combination products, also in October in Bethesda, MD, highlighting efforts to update existing guidances and to prepare additional advisories on labeling issues and bridging studies.
A …
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
Cleaning validation regulatory guidance
FDA’s 1998 cleaning validation guidance document focuses on general aspects and qualification of the cleaning process (1). The design and post-validation mo…
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Framing Biopharma Success in 2016
To encourage manufacturers to adopt new production technologies, FDA issued a draft guidance document (5) in December 2015 that provides a framework for drug manufacturers and FDA to discuss manufactu…
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Quality Systems Key to Lifecycle Drug Management
FDA issued a guidance in March 2014 that sought to expand the range of manufacturing changes that can be documented in annual reports, but the list was fairly limited, and industry has found it incons…
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Labeling of Biosimilars
In December 2014, guidelines on quality standards for biosimilars with proteins as an active substance came into effect (1), while guidance on clinical and non-clinical issues with the products was be…
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Monoclonal Antibodies Key to Unlocking the Biosimilars Market
In 2012, the EMA also published final guidance, the non-clinical and clinical requirements for biosimilar mAbs, including information on pharmaco-toxicologic, pharmacokinetic, pharmacodynamic, efficac…