Search results for " qualification"
Article
Aseptic Processing: Keeping it Safe
In this case, method development for detection and qualification of the leachable in the product solution would be required once the compounds of concern have been identified.”
Filter integrity te…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
As process validation Stage 2 (process qualification) begins, criticality is applied to develop acceptance criteria for equipment qualification and process performance qualification. Finally, in proce…
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
In this approach, criticality is used as a risk-based tool to drive control strategies (Stage 1), qualification protocols (Stage 2), and continued process verification (Stage 3). Overall, a clear road…
Article
Supplier-Change Management for Drug-Product Manufacturers
These deliverables may include, but are not limited to:
• Receipt of additional information from the supplier
• Execution of qualification studies or review of supplier validation summaries
…
Article
PDA's Technical Report for Biotech Cleaning Validation
The report uses a life-cycle approach to biotechnology cleaning validation that encompasses design and development, process qualification, and ongoing control of effectiveness. It also considers the r…
Article
Host-Cell Protein Measurement and Control
PAbs generated by immunizing animals with these HCPs will be used for ELISA development upon qualification by a 2D-coverage assessment. The pAbs should recognize a large majority of HCPs coproduced wi…
Article
Modular Manufacturing Platforms for Biologics
…, biologics bulk, or aseptic filling to be built in only 12 months from project start to operational qualification, estimates Almhem. Pods can be built in an even shorter amount time, says Jornitz. “…
Article
Securing the Single-Use Supply Chain
An alternative supplier’s products must be assessed with the same science-based qualification process, and if different suppliers adopt slightly different approaches, the end-user must determine what …
Article
QbD and PAT in Upstream and Downstream Processing
Johanning (QAtor): Before (traditional) installation, test and qualification of equipment a QbD approach involves a design qualification, where the user requirement specification (URS), which includes…
Article
Implementing Inline Conditioning to Advance Process Intensification
Our people were able to travel to Sweden for the equipment qualification and perform some preliminary testing there. After we received the equipment on our site, we performed a feasibility study, foll…