Search results for " ICH"
Article
Evaluating Design Margin, Edge of Failure and Process
Conclusion
Modern drug development and ICH standards encourage design space generation in new product development. It is a best practice and increases product and process knowledge and reduces ris…
Article
Challenges in Analytical Method Development and Validation
Guo (FDU): The International Conference on Harmonization (ICH) has a general guidance on method validation, ICH Q2(R1): Validation of Analytical Procedures: Text and Methodology (3). This is the guida…
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
This tighter space is the last part of the ICH Q8 paradigm (2) (see Figure 2) and is called the control space, which equates to normal operating range (NOR) limits for each CPP.
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Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
The ICH guidance defines three elements--knowledge space, design space, and control space--to establish a process understanding (see Figure 2) (2).
ICH Q8 defines design space a…
Article
Using Multiple Techniques in Biosimilar Analysis
Application of multiple techniques at different conditions presents a more complete picture of a dynamic situation.
By Rebecca Strawn
Sergey/stock.adobe.com
Almost all drug product…
Article
Critical Quality Attributes Challenge Biologics Development
Regulations and risk assessment
BioPharm: Are the regulations for CQAs and QbD different for biologics? If yes, how?
Das (BMS): The ICH guideline [(ICH) Q8 (R2)] is commonly followed for CQA a…
Article
Quality Systems Key to Lifecycle Drug Management
An ICH expert working group discussed a Q12 concept paper in Lisbon, Portugal in November 2014, and a more detailed proposal is scheduled for further discussion at the June ICH steering committee meet…
Article
Quality by design for biotechnology products—part 1
This paper focuses on the factors to consider when applying the QbD concepts outlined in ICH Q8(R2), Q9, and Q10 to biotechnology products. The paper is intended to capture and reflect both the curren…
Article
Addressing the Complex Nature of Downstream Processing with QbD
ICH, ICH Q8 R2, Pharmaceutical Development (ICH, August 2009).
2. L. X. Yu et al., AAPS Journal 16 (4) (July 2014).
3. CMC Biotech Working Group, A-Mab Case Study.
Article
Putting Viral Clearance Capabilities to the Test
Process understanding and careful assessment of risks are essential in developing viral clearance programs.
By Rita C. Peters
nobeastsofierce/Shutterstock.com
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