Search results for " guidance"
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Biopharma Advances Demand Specialized Expertise
Integrating risk-based review, GMP inspection, implementation of quality by design, and the new FDA process validation guidance within one office is expected to significantly change the biopharmaceuti…
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Modern Manufacturing Systems Key to FDA Quality Initiative
OPQ’s Office of Policy for Pharmaceutical Quality (OPPQ) is examining current policies and areas where risk-based regulation and guidance would encourage continuous quality improvement by industry thr…
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New Era for Generic Drugs
Small manufacturers asked FDA for reduced annual facility and filing fees, and several industry executives urged more clarity in how new guidance would be implemented. They offered specific comments o…
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Using Quality by Design to Develop Robust Chromatographic Methods
The concept of quality by design (QbD) was introduced to the pharmaceutical industry in the International Conference on Harmonization (ICH) guidance documents, ICH Q8-Q11 (1-4), as a way to develop ro…
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Manufacturers Struggle with Breakthrough Drug Development
FDA briefly outlined the basic components of manufacturing development programs needed for approval of breakthroughs in a June 2013 guidance (1). To ensure availability of a quality product at time of…
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Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
FDA's 2007 draft guidance for industry defines TPP as a format for a summary of a drug development program described in terms of labeling concept (1). QTPP is defined in ICH Q8 (R2) as "a prospective …
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Free handbook for column packing and maintenance
Impossible to get right? This new handbook can help! Packed with valuable guidance for using AxiChrom™, BPG and Chromaflow™ columns, you’ll discover ways to pack every column quickly and consistently.…
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Chromatography for the Diversified Antibody Pipeline
Furthermore, we have experienced that FDA has published their guidance for development of this new class of antibodies. I believe everyone is expecting that they will increase in the future.
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Report from the 12th Plasma Product Biotechnology Forum
Dorothy Scott, FDA’s Branch Chief of the Plasma Derivatives Branch, discussed the challenges on plasma supply and during the Covid-19 pandemic, which forced new regulatory guidance to be applied. One …
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Understanding Protein Production from Start to Finish
This article covers their expert guidance, insight, and tips to help you make fast progress in protein research.