Search results for " guide"
Article
New Selection Guide: Ion Exchange Chromatography Columns and Resins
Use these decision trees to find the most appropriate resin for your needs.
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Article
Protein Purification Troubleshooting Guide
Practical advice to significantly impact your chromatography workflow
Put this poster on your lab wall to quickly identify and resolve protein purification problems when and where they happen. I…
Article
Selection Guide Size Exclusion Chromatography Columns and Media
Size exclusion chromatography (SEC), also called Gel filtration (GF), separates molecules on the basis of differences in size as they pass through a SEC medium packed in a column. A variety of media…
Article
Advancing QbD in the EU
These guidelines cover pharmaceutical development concepts in Q8, quality risk management (QRM) in Q9, and a pharmaceutical quality system to be implemented in the different stages of a product lifecy…
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Evaluating Surface Cleanliness Using a Risk-Based Approach
The design and post-validation monitoring aspects are factored into the validation process, but are not specified in the regulatory guide nor in the industry practices. Today, this is referred to as t…
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Design and Qualification of Single-Use Systems
• Documentation should also be considered as part of product design, to include support data for performance claims, design and production validation data reports, operation guides, and other informat…
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Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
Both the Parenteral Drug Association (PDA) Technical Report 60 (7) and the International Society for Pharmaceutical Engineering (ISPE) Product Quality Lifecycle Initiative (PQLI) guide series (8-10) p…
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Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
ICH, Q8(R2) Harmonized Tripartite Guideline, Pharmaceutical Development, Step 4 version (August 2009).
3. ICH, Q9 Harmonized Tripartite Guideline, Quality Risk Management (June 2006).
4. ICH, …
Article
Understanding Validation and Technical Transfer, Part I
FDA’s 1987 process validation guideline defined validation as “Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product me…
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Best Practices in Qualification of Single-Use Systems
Because chemical compatibility is determined by the concentration of contacting fluid, the nature of the polymer, the contact time, and temperature, Table II can only be used as a general guideline. W…