Search results for " risk-based"
Article
QbD and PAT in Upstream and Downstream Processing
Girard (Spinnovation): Precisely because QbD is a scientific, risk-based, and proactive approach to biologics development, one can use it to define the ideal characteristics of a product to achieve CQ…
Article
Advancing QbD in the EU
This approach would provide opportunities for "a more science- and risk-based approach" in assessing manufacturing changes.
In a joint comment, the European Federation of Pharmaceutical Industr…
Article
The Lifecycle Change of Process Validation and Analytical Testing
LIFECYCLE VERSUS TRADITIONAL VALIDATION
BioPharm: How does a lifecycle approach to process validation that employs risk-based decision-making throughout that lifecycle differ from traditiona…
Article
PDA's Technical Report for Biotech Cleaning Validation
49 include change control, risk-based periodic monitoring, and data trending review. Training and retraining for manual cleaning processes are also significant because they are the primary mechanisms …
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
The purpose of the pilot program is "to gain more information on and facilitate agency review of QbD, risk-based approaches for manufacturing biotechnology products". These approaches link "attributes…