Search results for " ICH"
Article
Cleaning of Dedicated Equipment: Why Validation is Needed
International Conference on Harmonization (ICH) guidance ICH Q9 (1) encourages that a quality risk management approach be considered and that, based on the level of risk, cleaning processes may be sub…
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
Per ICH Q9, there are two primary principles of quality risk management (3):
• The evaluation of risk to quality should be based on scientific knowledge and ultimately link to the protection of th…
Article
Quality by Design—Bridging the Gap between Concept and Implementation
Lessons from a QbD dossier
In a QbD dossier drawn up by GlaxoSmithKline (GSK), which was the subject of a case study presented at the meeting, the company used terms created before the ICH guidel…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
In contrast to genetic suitability, more traditional genetic stability studies refer to the characterization of the production cell lines used for commercial drug substance manufacturing followed the …
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
“This characterization should include the determination of physicochemical and immunochemical properties, biological activity, purity, impurities, and quantity of the mAb, in line with ICH Q6B guideli…
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Design of Experiments for Analytical Method Development and Validation
Normally five concentrations should be evaluated per ICH Q2R1.
Define all Reference Standards Used in the Study
Develop/define the reference standards for bias and accuracy studies. Wi…
Article
Robust Optimization, Simulation, and Effective Design Space
Even though there are ICH guidance documents such as Q8 and Q11 that define what a design space is, there is still a poor understanding of the meaning and application of a design space.
ICH Q8, Ph…
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Impurity Testing of Biologic Drug Products
Other aspects of method validation are more easily derived from the guidance given in ICH Q2 (R1).
Analytical methods
BioPharm: What are the commonly used analytical methods for charac…
Article
Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
…straZeneca: We are required to follow International Conference on Harmonization (ICH) Q9 for QRM and ICH Q10 (1, 2) for the risk oversight by senior quality management. Regulatory expectations exist …
Article
Host-Cell Protein Measurement and Control
… accepted that a sensitive, validated method is required to monitor residual HCPs in accordance with ICH guidelines. The allowed amount of residual HCPs in final bulk material is determined on a case…