PAT Initiatives for QC/QA Operations: Enabling Paperless Processes for Manufacturing Batch Records and QC Laboratories

Article

Special Issues

LCGC SupplementsSpecial Issues-07-01-2006
Volume 0
Issue 0

This paper outlines the current situation in manufacturing and quality operations relative to industry compliance initiatives and manufacturing challenges. It profiles an innovative ?method-centric? software platform, designed for the analyst or operator, to electronically execute and man-age quality control testing protocols and production batch records, yielding significant reductions in overall product release cycle time.

External Link - article-416322.pdf

Articles in this issue
Analytical Instrument Qualification
GMP and Phase I Clinical Trials: Streamlining the Critical Path?
GMP and Phase I Clinical Trials: Streamlining the Critical Path?
Team Effort
Team Effort
Rated PG: Pharmaceutical Guidance Suggested
Rated PG: Pharmaceutical Guidance Suggested
European Clinical Trial Regulations Undergo a Slow Revolution
European Clinical Trial Regulations Undergo a Slow Revolution
A Practical and Cost-Effective Risk Assessment for the Validation of Commercial Laboratory Computerized Systems
A Practical and Cost-Effective Risk Assessment for the Validation of Commercial Laboratory Computerized Systems
Moving Biotech Products from CBER to CDER: A Work in Progress
Moving Biotech Products from CBER to CDER: A Work in Progress
FDA Video Interview Conducted by Jill Wechsler, Washington Bureau Chief
New Climate
New Climate
2006: A Regulatory Odyssey
2006: A Regulatory Odyssey
CDER?s Division of Post-Marketing Evaluation for Quality Assessment
CDER?s Division of Post-Marketing Evaluation for Quality Assessment
Better Compliance Through Technology
Better Compliance Through Technology
Good Clinical Practice Q&A
Good Clinical Practice Q&A
Keeping Pace
Keeping Pace
The Growing Regulatory Burden and Revolution in Global Clinical Trials
The Growing Regulatory Burden and Revolution in Global Clinical Trials
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