Search results for "quality risk management"
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
Quality risk management
Risk is the combination of the probability of occurrence of harm and the severity of that harm (5, 6). The value of risk assessment models is the formalized evaluation crit…
Article
Quality by design for biotechnology products—part 1
Scientific understanding and prior knowledge can be used together with quality risk management to prioritize which process parameters to study. One tool that is useful for documenting factor risks is …
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
…In this context, viral risk mitigation should be an integral part of the overall quality system and quality risk management strategy (12). Viral safety needs to be designed into the overall drug-deve…
Article
State of Quality and Compliance in the Biopharmaceutical Industry
Have FDA initiatives improved manufacturing quality?
The late 1990s and early 2000s witnessed a slew of enforcement actions by FDA that included multiple Form 483 observations, warning le…
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
ICH, Q9 Harmonized Tripartite Guideline, Quality Risk Management (June 2006).
4. ICH, Q10, Harmonized Tripartite Guideline, Pharmaceutical Quality System (April 2009).
5. J. J. Peterson, J Bio…
Article
Eliminating Residual Impurities Starts with a Strategic Plan
ICH, Q9, Quality Risk Management, Step 4 version, (2005).
6. ICH, Q3C (R6), Maintenance of the Guideline for Residual Solvents, Final version (2016).
7. ICH, Q3D (R1), Guideline for Elementa…
Article
Securing the Single-Use Supply Chain
Dual sourcing is one of many possible solutions to securing the supply chain.
Single-use systems (SUS) have become established in biopharmaceutical drug development. As confidence in the technol…
Article
Modern Manufacturing Systems Key to FDA Quality Initiative
Apr 02, 2015
By Jill Wechsler
Pharmaceutical Technology
Volume 39, Issue 4
To ensure patient access to high quality, safe, and effective medicines, FDA spends considerable time and resou…
Article
Assessing Manufacturing Process Robustness
…ity attributes (CQAs) and critical process parameters (CPPs) as per ICH Q8
applying quality risk management tools as per ICH Q9
documenting a critical manufacturing eq…
Article
Quality by Design and Extractable and Leachable Testing
The author discusses the various ways in which a quality-by-design program can enhance the extractable and leachable assessment of a drug product.
Feb 01, 2015
By Anthony Grilli
BioPharm…