Search results for " raw materials"
Article
Addressing the Complex Nature of Downstream Processing with QbD
The impact of variability regarding raw materials can be felt first in commercial manufacturing because of a lack of relevant test material during process characterization. “The only viable approach t…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
For large studies, multiple lots of raw materials may be required. Consideration should be given to either proportional mixing of the raw material lots for each run or use of a statistical technique c…
Article
Using Digital Twins to Model Process Chromatography
Mechanistic models provide process understanding for developing robust manufacturing processes and for scale up and tech transfer.
By Jennifer Markarian
A digital twin is a model of a proces…
Article
Gowning Practices Provide Clues to cGMP Compliance
Review gowning practices as a tool to evaluate cGMP compliance in a facility.
The foundation of any successful quality-assurance system is strict adherence to good manufacturing practices (GMP…
Article
Design of Experiments for Analytical Method Development and Validation
Design of experiment is a powerful development tool for method characterization and method validation.
Design of experiments (DOE) is a well-proven characterization approach within product…
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
… space)
• Acceptance criteria and sampling requirements for CQAs, in-process controls, and raw materials testing
• In-process hold (non-processing) time limits and storage conditions …
Article
Moving PAT from Concept to Reality
“Regulators expect process monitoring and controls based on the entire batch data and the ability to revise controls to compensate for raw material variability or the use of different batches of raw m…
Article
Putting Viral Clearance Capabilities to the Test
The source of starting materials and raw materials used in production are of primary concern, says Bergmann, and a risk assessment identifies which viruses are likely to be contaminants and the levels…
Article
GMP Challenges for Advanced Therapy Medicinal Products
In particular, they often do not have adequate systems in place for evaluating the quality of starting and raw materials, which is a vital necessity in the production of advanced, usually biological, …
Article
Robust Optimization, Simulation, and Effective Design Space
Jul 01, 2015
By Thomas A. Little, PhD
BioPharm International
Volume 28, Issue 7, pg 40–44
Approaches to the generation of process models, optimization techniques, and application of …