Search results for " manufacturing changes"
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Continuous Manufacturing: A Changing Processing Paradigm
points out that in continuous processing, sampling considerations will differ from batch; deviations might need to be handled differently; variability should be controlled; manufacturing changes manag…
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Efforts Accelerate to Streamline Postapproval Change Process
Together, these approaches provide confidence that the firm can manage most manufacturing changes and justify modified postapproval reporting requirements.
To spur the Q12 process, FDA in 2015 iss…
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The Lifecycle Change of Process Validation and Analytical Testing
In the two years since the publication of FDA's final process validation guidance, how has this new lifecycle approach affected the way the industry performs validation? BioPharm Internati…
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Climate Change in Outsourcing
As 2013 draws to a close, the bio/pharmaceutical industry continues to be reshaped by changes in the business climate. Financial, political, and scientific developments that began 10 years ago conti…
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EMA Guidance on Changes to COVID-19 Vaccines to Fight Variants
The agency is developing guidance to help manufacturers make changes to existing COVID-19 vaccines to treat new variants in the coronavirus.
The European Medicines Agency (EMA) has requested t…
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Discovering the unknown: How does in silico process development change PD scientists’ work?
In silico process development for chromatography is a paradigm-shifting approach that redefines the routine work of process development scientists. But what does it actually mean to perfor…
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Regulatory Challenges in the QbD Paradigm
Regulators also must offer more flexibility regarding manufacturing changes and application supplements based on science and risk assessment, so that limited resources on both the industry and regulat…
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Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical change management processes extend to the materials and services employed to manufacture and test drug products, necessitating the need for an effective supplier-initiated change …
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Quality Systems Key to Lifecycle Drug Management
And new policies and procedures at FDA aim to streamline oversight of manufacturing changes for firms that adopt modern production methods able to ensure the continued safety and efficacy of products …
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Maximum Output Starts with Optimized Upstream Processing
By Cynthia A. Challener
Biopharmaceutical companies and contract manufacturers respond to changing demand dynamics for upstream bioprocessing capacity.
Significant growth in the develo…