Search results for " documentation"
Article
Best Practices for Data Integrity
These investments usually occur in the form of additional manual document reviews, more rigorous quality documentation, hiring more personnel, implementing electronic systems, and so on.
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Article
Being Thorough When Transferring Technology
Procedures that govern technical documentation requirements gated to each stage of development ensure that critical information is captured and available for tech transfer. For example, required clini…
Article
Establishing Acceptance Criteria for Analytical Methods
Knowing how method performance impacts out-of-specification rates may improve quality risk management and product knowledge.
By Thomas A. Little, PhD
To control the consistency and quality o…
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PDA's Technical Report for Biotech Cleaning Validation
The industry needs to provide more scientific rationales and data to support that practice, and such improvements in support documentation have started to occur.
SAMPLING METHODS
Another key p…
Article
Monitoring and Control of Inline Dilution Processes
The buffer dilution system was designed, automated, and manufactured by YMC, and together the companies provide documentation, support, and on-site services with a “360-degree buffer dilution solution…
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Managing Risk in Raw Material Sourcing
Data transparency now the norm
Pharmaceutical manufacturers are demanding not only cGMP compliance, documentation support, and close management of critical changes, but increased information trans…
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Biosimilars to Drive Modern Manufacturing Approaches
Reliable, high-quality products require innovative analytics and production.
By Jill Wechsler
As more biosimilars gain market approval in the United States, and manufacturers launch addition…
Article
Advancing Single-Use Technology Through Collaboration
In addition to standardizing testing, documentation, and process steps, it will also be necessary to make strides toward standardizing design features as well. Even though all manufacturers deal with …
Article
Quality Systems Key to Lifecycle Drug Management
Jun 01, 2015
By Jill Wechsler
BioPharm International
Volume 28, Issue 6
The submission and review of manufacturing supplements is costly and time consuming for biopharmaceutical comp…
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
This documentation includes or references the following:
• Continuum of criticality for process parameters
• Continuum of criticality for quality attributes
• The mechanistic o…