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Journal of GXP Compliance: Current Issue
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Journal of GXP Compliance 
WINTER 2010, VOLUME 14, NUMBER 1




 

CURRENT ISSUE:

PEER-REVIEWED
Qualification of Employees for GXP Compliance
Author: Gordon Welty

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

From the Coordinating Editor
Author: Susan Haigney

2009 IVT Awards Presentation

EAB Spotlight: Scott V.W. Sutton, Ph.D. and Valerie Welter

Cleaning Compliance Forum: Is Swabbing a Regulatory Requirement?
Author: Jennifer Carlson

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

Auditor Tales: Animal Tales
Author: Michael H. Anisfeld

GXP Training Tips: Using Stories, Anecdotes, and Metaphors to Make your GXP Training Come Alive
Author: David Markovitz

Global Regulatory Viewpoint: FDA 483 Responses—Compliance Considerations
Authors: Richard Poska and Ballard Graham

Compliance Case Studies: Compliance Case Study #2—Questionable Equipment Qualification
Author: Timothy J. Fields

Compliance Case Studies: Compliance Case Study #3—Manual Processes, Performance, Responsibilities, and Training
Authors: Paul L. Pluta, Timothy J. Fields, and Alan J. Smith

Compliance Case Studies: Compliance Case Study #4—Cleaning Validation Unknown HPLC Peaks
Author: Paul L. Pluta

GLP Forum: Physicochemical Testing and the GLPs
Author: Steven S. Kuwahara

GLP Topics: Facilities—Design and Sustainability for Harmonizing GLP
Author: Jeff Morgan

Microbiology Topics: Hand Washing, Hygiene, CGMP, and Science
Author: Scott Sutton

Pharmaceutical Processes: Fundamentals of Tablet Compression
Author: Armin H. Gerhardt

Commentary: FDA is Coming to a Tobacco Product Manufacturing Plant Near You
Author: John H. Lauterbach





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