Search results for " documentation"
Article
Challenges in Analytical Method Development and Validation
Proper documentation including import licenses, if necessary, should be obtained in advance. To ensure the success of method transfer, the analytical methods should be evaluated by the receiving labor…
Article
Monoclonal Antibodies Key to Unlocking the Biosimilars Market
The biosimilars market, many analysts believe, is on the cusp of significant growth. This growth in large part is due to the fact that numerous monoclonal antibody (mAb) biosimilars are expect…
Article
Design of Experiments for Analytical Method Development and Validation
• Define the steps in the method and any associated documentation.
• Determine the responses that are aligned to the purpose of the study.
• Complete a risk assessment of all materials, equipm…
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FDA and EMA Extend QbD Parallel-Assessment Pilot Program
FDA and the European Medicines Agency (EMA) have extended the joint pilot program for the parallel evaluation of quality-by-design (QbD) applications for two years beginning April 1, 2014. In the jo…
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Best Practices in Adopting Single-Use Systems
The system should arrive with the required regulatory documentation, ready to use. At one time, bioprocessors made routine modifications to single-use systems at their facilities. These days, it is be…
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Operational Excellence: More Than Just Process Improvement
Working together, the quality and operations groups were then able to dramatically improve the rate of right-first-time documentation. The quality function created new roles designed to partner with o…
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Essentials in Quality Risk Management
Clear action owners, implementation timelines, and an effective documentation and review process are needed to make the needed and identified changes happen.
QRM TOOLS
QRM tools are…
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A Look Ahead at BioPharma Manufacturing and Regulation
The FDA talks about the changing scope of regulatory science.
Regulatory science underpins innovation and practices in drug manufacturing. The most common definition of r…
Article
Quality by design for biotechnology products—part 1
A PhRMA Working Group's advice on applying QbD to biotech.
By Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman, Jutta Look, Tony Lubiniecki, Joseph Mezzatesta,…
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Sterilization Trends for Single-Use Consumables
Generally, documentation is provided with each component/system.
Three key trends: capacity, complexity, and process control
The increasing use of SU technologies for biologic drug manufacturing h…