Special Edition

Roadmap to GMP Compliance Part I | IVT

If you're looking for help with GMP, this special edition covers all the bases from GMP failures to reviewing batch production records and beyond.

GMP Failures: Ignorance or Arrogance?
Michael H. Anisfeld

Implementing the Tools of Process Quality — A Policy Statement
Lynn Torbeck

Data Culture
Lynn Torbeck

An Example of Absence of a Data Culture
Lynn Torbeck

Upsizing Compliance in a Downsizing Environment: Strategies for Ensuring GXP Compliance in the Face of Cost Reductions
Eldon Henson

Strategies for Addressing the Problems of Subjectivity and Uncertainty in Quality Risk Management Exercises Part I and II — The Role of Human Heuristics
Kevin O’Donnell

GXP Excellence by Design (XbD): Applying the Principles of Excellence to the GXP Environment
Eldon Henson

Review of Batch Production Records
David Jones

GMP Yield–Considerations Beyond Percent Theoretical Yield
Paul L. Pluta and Richard Poska

Substandard Data and Documentation Practices—Case Study #9
Paul L. Pluta and Timothy J. Fields

Effective Personnel Qualification — Does the Job Description Play a Role in CGMP Compliance?
Eldon Henson

Reader Q & A-Q#36 Deviations and Exceptions in Validation Protocols Q#37 WFI Sampling and Testing
Jerry Lanese and Alan J. Smith

Reader Q & A-Q#32 FDA Audits Q#33 PAT
Jerry Lanese and Alan J. Smith

Reader Q & A-Q#28 QA ROI Q#29 ISO and ICH Q10
Jerry Lanese and Alan J. Smith

Reader Q & A-Q#26 Prototypes for Clinicals Q#27 Packaging Testing
Jerry Lanese and Alan J. Smith

Reader Q & A-Q#40 What is a complaint? Q#41 Documentation for Raw Material Inspections
Jerry Lanese and Alan J. Smith

Download the entire Roadmap to GMP Compliance Part I

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