Search results for " guidance" in Articles / App Notes
Article
Sterilization Trends for Single-Use Consumables
The standards also, Hatchcock adds, provide guidance on how to migrate from one technology, such as gamma, to another, such as X-ray.
Hathcock goes on to point out that not all SU components and s…
Article
Digitalization: The Route to Biopharma 4.0
One of the critical FDA guidance documents that applies to digitalization efforts is that of Part 11 of Title 21 of the Code of Federal Regulations (Electronic Records; Electronic Signatures). This do…
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Pandemic Alters Policies and Practices for Drug Development and Regulation
Sponsors gained important advice from FDA on conducting clinical trials during the pandemic from a steady stream of new guidance documents addressing the need for flexibility while maintaining study i…
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Maximum Output Starts with Optimized Upstream Processing
Across the industry, though, Vanek believes there has been a gap in investment capital for companies that have launched these innovative products but still require guidance to fully scale and industri…
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Remote Monitoring and Big Data Advance Upstream Automation
In some cases, these activities, which can include providing guidance and training to facility workers, proceed via remote connections available in the automation systems, while in others they take pl…
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Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
A major advantage of SPR-based analysis is its ability to estimate the association and dissociation rate constants, an …
Article
Roadmap Leads to Innovative Biomanufacturing Strategies
For example, there is already a desire to make progress in certain workstreams so that they will be in a position to influence new guidance documents expected from the International Council for Harmon…
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Avoiding Investigational Failures and Discrepancies
Avoiding Investigational Failures and Discrepancies
Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.
By Walt Murray,…
Article
Being Thorough When Transferring Technology
The technology transfer procedures implemented are typically guided by International Council for Harmonization (ICH) Q10 or equivalent guidance from other regulatory authorities. This guidance is prac…
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Speed and Flexibility Are Dual Goals for Biopharma Operations
In a draft guidance for industry, Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base (December 2015), the agency outlined a process for biopharmaceutica…