Search results for " guidance"
Article
Managing Residual Impurities During Downstream Processing
“As biologic manufacturing and biologic product knowledge continue to expand, there will be a constant requirement to adapt and amend both thought processes and guidance,” Wake states.
Role of publ…
Article
Efforts Accelerate to Streamline Postapproval Change Process
To spur the Q12 process, FDA in 2015 issued a draft guidance on defining and reporting ECs (2). The guidance describes which elements of a control strategy could be considered ECs necessary to assure …
Article
The Metrics of Quality Culture
Schniepp
The long awaited, anxiously anticipated FDA guidance on quality metrics was finally distributed for comment on July 28, 2015. The official title of this guidance for industry is Request f…
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…
Article
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…
Article
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…
Article
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…
Article
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…