Journal of GXP Compliance: Current Issue
 - Institute of Validation Technology

 Don't miss this issue -- SUBSCRIBE TODAY!
          Domestic        International       Digital



Journal of GXP Compliance 
SUMMER 2010, VOLUME 14, NUMBER 3




 

CURRENT ISSUE:

PEER-REVIEWED
Improved Utilization of Self-Inspection Programs within the GMP Environment—A Quality Risk Management Approach
Author: Barbara Jeroncic

DEPARTMENTS
From the Editor-in-Chief
Author: Paul L. Pluta

From the Coordinating Editor
Author: Susan Haigney

EAB Spotlight: Book Reviews

GXP Talk: Reader Q&A
Editors: Jerry Lanese and Alan J. Smith

GXP Training Tips: Think Before You Act
Author: David Markovitz

Effective GMP: Numerical Evaluations of Training Sessions
Author: Lynn Torbeck

Microbiology Topics: The Environmental Monitoring Program in a GMP Environment
Author: Scott Sutton

Pharmaceutical Processes: Two-Piece Hard Capsules for Pharmaceutical Formulations
Author: Dennis Murachanian

GLP Forum: Membership of the Institutional Animal Care and Use Committee (IACUC) and GLP-Regulated Studies
Author: Steven S. Kuwahara

Computer Systems Quality and Compliance: System Design and Control
Author: Robert H. Smith

Cleaning Compliance Forum: Avoiding Pitfalls of Cleaning Validation
Authors: Paul L. Pluta and Rizwan Sharnez

Compliance Case Studies: Compliance Case Study #6—Process Validation Failure—Liquid Product Batch Size Increase
Author: Paul L. Pluta

Compliance Case Studies: Compliance Case Study #7—Broken Punches in Tablet Compressing
Author: Paul L. Pluta

Global Regulatory Viewpoint: GMP Yield—Considerations Beyond Percent Theoretical Yield
Authors: Paul L. Pluta and Richard Poska





Journal of GXP Compliance (JGXP)
GXP

JGXP provides useful information on regulated activities including GLP, GCP, and GMP. General information on compliance topics applicable to GLP, GCP, and GMP is also provided. The Journal embraces a comprehensive approach to compliance. This includes information on activities in advance of and in support of respective compliance performance, demonstration of compliance, and activities to maintain a compliant state. Information may include basic concepts, strategic approaches, expert commentary, experimental and laboratory studies, applications, actual compliance performance, and case studies. Technical papers are peer-reviewed.

JGXP current or pending regular features supporting editorial strategy include:

GLP Compliance

  • GLP Topics: GLP topics of interest, coordinated by Cynthia Green

GCP Compliance

  • GCP Topics. GCP topics of interest, coordinator pending

GMP Compliance

  • Cleaning Topics: Cleaning topics with focus on compliance, coordinated by Rebecca Brewer

  • Compliance Methods: Analytical methods with application to compliance and problem solving, coordinated by Paul Pluta

  • Engineering for Non-Engineers: Engineering topics with focus on compliance, coordinated by Stephen Perry

  • GMP Topics: Key points on GMP topics, coordinated by Troy Fugate

  • Microbiology Topics. Topics of interest with focus on compliance, coordinator pending

  • Pharmaceutical Processes: Technical pharmaceutical processes with focus on compliance, coordinated by Armin Gerhardt

General Compliance

  • Auditor Tales: Experiences and discussions by a GMP auditor, coordinated by Michael Anisfeld

  • Global Regulatory Viewpoint: Topics of regulatory and compliance interest including interviews with global regulatory personnel, coordinated by Richard Poska

  • GXP Talk: Reader Q&A addressing GMP issues, coordinated by Jerry Lanese and Alan Smith

  • GXP Training Tips: Useful ideas for training programs, coordinated by David Markovitz

  • Statistical Viewpoint: Applications of statistics to compliance and validation, coordinated by David LeBlond