Search results for " qualification" in Articles / App Notes
Article
Cleaning of Dedicated Equipment: Why Validation is Needed
EDQM, EudraLex, Volume 4, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, “Annex 15: Qualification and Validation” (in force from October 1, 2015).
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Article
Breakthrough Drugs Raise Development and Production Challenges
Manufacturers need to decide dosage form and methods validation strategies much sooner, he said at the CMC workshop, and should “plan for the unexpected,” such as facility qualification failures and c…
Article
Ensuring the Quality of Biologicals
standards have a role during the development of biosimilars as they are used for method qualification and validation. Where biosimilars have been approved for use in the European Union, there are corr…
Article
Re-use of Protein A Resin: Fouling and Economics
Mar 01, 2015
By Anurag S. Rathore, Mili Pathak, Guijun Ma, Daniel G. Bracewell
BioPharm International
Volume 3, Issue 28
In the past two decades, Protein A affinity chromatography ha…
Article
Quality by Design and Extractable and Leachable Testing
QbD also considers potential product quality influencers outside of the testing program, such as issues with vendor qualification and disruptions in supply chain management.
References
1. S.…
Article
Improving PAT for Biologics
Most importantly, interface issues between single-use components, sensors, and local control and SCADA systems must be addressed to ease the implementation, qualification, and performance of PAT-enabl…
Article
Trends in Single-use Bioreactors
Because the single-use system is sterilized through gamma irradiation, qualifications and validation efforts that are usually required with tradition stainless-steel systems are reduced, and as a resu…
Article
Best Practices in Adopting Single-Use Systems
Vendor relationship
Because the business relationship between supplier and customer may last many years, vendor qualification is crucial. Top vendors view customer interactions as opportunities to …
Article
Quality by design for biotechnology products—part 1
Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics. J Immunol Methods. 2…