IVT – GXP Journal Archive

Journal of GXP Compliance Archive

Vol. 26, Issue 2, Mar 2022


Avoiding Errors With The Batch Release Process: Best Practice CGMPs
Author: Tim Sandle

Medication Safety – Pharma Industry Considerations Questions From Readers #2
Author: Paul L. Pluta
Calculations Roundtable #1: Invitation To Participate; Nishant B. Thakar
Author: Paul L. Pluta

FDA Seek Comments on Quality System (QS) Regulations Amendments

Author: IVT Staff

Quality Plans for Pharmaceuticals and Healthcare: Checking the Maturity of Your Quality System
Author: Tim Sandle

Critical Thinking #4: Presenting Scientific Data Clearly and With Purpose
Author: Tim Sandle

Digital Data #4: Looking for Data Trends and Patterns With Visualization
Author: Tim Sandle

ICH Q9 Quality Risk Management Revision

Vol. 26, Issue 1, Jan 2022


Compliance Case Study #19: Primary Container Problems
Authors: Paul L. Pluta and Alan M. Mancini

Medication Safety – Pharma Industry Considerations Part 3 – High Alert Medications

Shadows of Missed Opportunities in Learning Excellence
Author: Lori Richter

What the Eye Can See: Vision Requirements for Personnel Who Inspect Injectable Pharmaceuticals
Author: Tim Sandle

Data Integrity Strategy Document Essentials
Author: Orlando Lopez

Membrane Filter Pore Size Selection For Microbial Testing
Authors: Nilesh Shah and Madhuri Powar

Regulatory 101: Safety of Titanium Dioxide
Authors: Karen R. Zimm, Renee Phillips

Investigations For Production Areas
Author: Jeanne Modenhauer

Managing Workplace Error Part 1: Unpicking Patterns of Human Error
Author: Tim Sandle

Vol. 25, Issue 6, Nov 2021


Animal-Derived Ingredients, FDA, and Regulations
Authors: Karen R. Zimm, Renee Phillips

Application of Validation Principles to the Training Quality System Part 8 – Training Process Documentation

Author: Paul L. Pluta

Improving Microbiological Control Of Non-Sterile Pharmaceuticals: Unlocking The FDA Guidance
Author: Tim Sandle

Setting Internal Limits And Its Application For Microorganisms Of Concern In Non-Sterile Pharmaceuticals
Author: Ratul Saha

Audit Forum – Audit Trails
Author: Jeanne Moldenhauer

CCS #18: Culture vs. Compliance
Author: Paul L. Pluta

Vol. 25, Issue 5, Sep 2021


Management Roundtable #3: Lessons From Restaurant Dishwashing
Author: Paul L. Pluta

Monte Carlo Simulation Using Microsoft Excel to Estimate the Probability of Passing USP Dissolution Test

Author: Prasanth Sambaraju

The Importance of Not Being Too Attached: Pharmaceutical Equipment Characteristics and Bacterial Attchment
Author: Tim Sandle

A Contamination Control Strategy Gone Wrong
Author: Jeanne Moldenhauer
Regulatory 101: Bulk Holding Time Requirements
Author: Karen R. Zimm, Renee Phillips

Critical Thinking #1: Why Pharmaceuticals and Healthcare Needs More Critical Thinkers – IVT BLOG

Author: Tim Sandle

Critical Thinking #2: Reading Research Papers – IVT BLOG
Author: Tim Sandle

Critical Thinking #3: Developing Questions to Achieve the Optimal Outcome – IVT BLOG

Author: Tim Sandle

CRISPR Therapeutics: New Emerging Developments and Clinical Applications – IVT BLOG

Author: Kaiser Jay Aziz

Vol. 25, Issue 4, Jul 2021


E-Records Integrity – Data Warehouse And Data Mart Layer

Author: Orlando Lopez

Good Practices For Managing A Safe Chemical laboratory Part 4: Records, Documents And Regulations
Author: Kurt L. Moyer, Richard C. Wedlich

Application of Validation Principles To The Training Quality System Part 7 – Training Management Overview
Author: Paul L. Pluta

Audit Forum: Lessons From previous FDA Observations – Drugs
Author: Jeanne Moldenhauer

Regulatory 101: What Do the cGMP Regulations Say About Recalls?
Author: Karen R. Zimm, Renee Phillips

Getting There: Strategies To Improve Gender Equality In Pharmaceuticals and Healthcare
Author: Tim Sandle

How To Ensure Senior Management Approval For Your Next Regulated IT System
Author: David Harris

Shining (Invisible) Light on Viral Pathogens: Virucidal Contamination Control Strategies Using UV-C Light
Author: Tim Sandle

Gene Therapy: Development, Design of Studies, and Approval Process – BLOG
Author: Kaiser Jay Aziz

Vol. 25, Issue 3, May 2021


Audit Forum: Invitation To Participate
Author: Jeanne Moldenhauer, Paul L. Pluta, Stacey L. Bruzzese

Face Mask Controls and Duration of Wearing: What Medical Research Can Teach the Cleanroom Manager
Author: Tim Sandle

Regulatory 101: Drug Names – Reader Q&A
Author: Paul L. Pluta
Statistics Roundtable #1: Invitation To Participate
Jeremy M. Ebersole

A Humidex For the Cleanroom: Why Temperature And Humidity Control Matters
Author: Tim Sandle

Good Practices for Managing a Safe Chemical Laboratory Part 3: Safety Administration and Facilities
Author: Richard C. Wedlich, Ulyana Matyugicheva

Audit Forum #1: Preparing For Remote GMP and GDP Audits
Author: Jeanne Moldenhauer

IVT Veteran Honored With Induction to Florida Inventors Hall of Fame
Author: Stacey L. Bruzzese

Updates Published for ICH E6 GCP Guideline: GMP for IMP Principles
Author: Stacey L. Bruzzese
Ventilators Dumped in Miami – Blog
Author: Vladimir Gostuski

Wearable Devices and Usage – BLOG
Author: Emilia N. Faraj

Risk-Benefit Analysis of the FDA’s Decision to pause J&J Vaccine – BLOG
Author: Coralin Nogues

Vol. 25, Issue 2, Mar 2021


Anatomy of a Contamination Control Strategy for Sterile Manufacturing
Author: Tim Sandle

Comtemporaneous Data Recording: How Does It Impact The Analytical Laboratory?
Author: Greg Vanderstel and Kim Huynh-Ba
Compliance Case Study #17: Spots On Tablets – An Investigation
Authors: Alan M. Mancini, Paul L. Pluta

Good Practices For Managing A Safe Chemical Laboratory Part 2: Safety Management Strategies

Authors: Richard C. Wedlich, ZemElia Miller
Regulatory 101: Biologic Non-Proprietary Drug Names – Terminology and Format
Authors: Karolina Cieslak, Paul L. Pluta

An Alternative Approach To Decontamination Of Beta-Lactam Antibiotic Residues With A Globally Available
Authors: Seth Robinson, Paul Lopolito, Elizabeth Rivera, Beth Kroeger-Gahnestock

Management Roundtable #1: Invitation To Participate
Authors: Paul L. Pluta, Stacey L. Bruzzese

Principles of Parental Solution Validation: A Book Review
Author: Paul L. Pluta

Temperature Scanners: Limited Value in Detecting Employee COVID-19 Symptoms?
Author: Tim Sandle

Vol. 25, Issue 1, Jan 2021


Cleanrooms and Associated Controlled Environments – Biocontamination Control: Dissecting The Standard
Author: Tim Sandle

Digitization of Validation For Effective Off-Site Regulatory “Review” and “Inspection”

Authors:Siva Samy, Ajaz Hussain, Alton Johnson

Good Practices For Managing A Safe Chemical Laboratory Part 1: People And Human Resources
Authors: Richard C. Wedlich and Kurt L. Moyer

Medical Cannabis as a Pharmaceutical – Part 3: Microbiological Risk and Quality Control
Author: Tim Sandle

Medication Safety and Drug names – Valproic Acid Product Problems; Marisol Avalos
Author: Paul L. Pluta
Regulatory 101: Preservative Efficacy Test
Author: Karen R. Zimm

Changes To Analytical Equipment/Instrumentation That Are Deemed Equivalent; Emma Ramnarine
Author: Richard Rolke

Shelf-Life Extensions For Pharmaceutical Products; Kevin Lombardi

Author: Nasir Egal

Crest of a Wave? Innovations with Personalized Medicine – BLOG POST
Author: Tim Sandle
Vol. 24, Issue 6, Nov 2020

Compliance Cast Study #16: Microbial contamination From Foods

ICH Q9 (R1) Quality Risk Management Revision
Author: Paul L. Pluta

Cannabis For Medical And Pharmaceutical Purposes – Part 1: An Overview Of The Development And Application
Author: Tim Sandle

Cannabis For medical And Pharmaceutical Purposes- Part 2: Analytical Quality Control

Author: Tim Sandle

Regulatory 101: The Basics of Post Approval/Variation Submissions In United States And European Union
Authors: Karen R. Zim and Renee King-Alliego

Application of Validation Principles to The Training Quality System. Part 6, Continued Training Verification
Author: Paul L. Pluta

Knowledge As The Currency Of Managing Risk: A Novel Framework To unite Quality Risk Management And Knowledge
Authors: Martin J. Lipa, Kevin O’Donnell, and Anne Greene

Restarting Your Facility – When Disaster Strikes
Author: Jeanne Moldenhauer

Microbial Contamination Concerns linked with E-Cigarettes and Vaping Products – A Blog Post from IVT Network
Author: Tim Sandle

Unexpected Toxicity From Drug Products – A blog post from IVT network
Author: Paul L. Pluta
Vol. 24, Issue 5, Sep 2020

26th Annual validation Week – All new Format, Same Trusted Thought Leadership
Author: Stacey L. Bruzzese

CQV #10: More Like for Like Problems
Author: Paul L. Pluta

Alternative Risks To Cleanrooms Presented By People: Tattoos, Piercings, Sunbeds
Author: Tim Sandle

Implementing Adequate Data Integrity Risk Assessment Tools
Author: Ivan Soto

Integrating Good Distribution Practice Into The QMS
Author: Tim Sandle

Managing Knowledge and Risk – A Lit Review on the Interdependency of QRM and KM as ICH Q10 Enablers
Authors: Marting J. Lipa, Keving O’Donnell, and Anne Greene

The Regulatory Affairs Management In Smart – Working: From The Lockdown Experience To Possible Future Scenarios
Authors: Nadia Esani and Joseph Brennan

Validation case Studies and Compliance Case Studies – Invitation to Participate
Author: Paul L. Pluta
Vol. 24, Issue 4, Jul 2020

COVID-19 And The Need For Robust Risk Control Strategies – Can ICH-Q9 Help?
Author: Umit Kartoglu, Kevin O’ Donnell and James Vesper

Facilitating The Lean Laboratory: A Case Study Using The 5 S Approach
Author: Tim Sandle

Intrinsic Compliance: A Model for Process Validation Optimization
Author: Cliff Campbell

Investigation of Deviations: Why Are They So Painful?
Author: Ivan Soto

Regulatory 101: The Basics of New Drug Application Submissions In Major Markets
Authors: Karen R. Zimm and Renee King-Alliego

Reusable Gowning In Viral Vector Services
Author: Ratul Saha

Understanding the Concept of Formality In Quality Risk Management
Authors: Kevin O’Donnell, Deidre Tobin, Stephanie Butler, Ghada Haddad, and Donal Kelleher

IVT Management Roundtable #1: Invitation To Participate – Written, Audio, Visual, And In-Person
Authors: Paul L. Pluta, Stacey L. Bruzzese

The Benefits Of Utilizing A Spectrum Of IMportance In Industry
Authors: Daniel O’ Regan and Cliff Campbell

Vol. 24, Issue 3, May 2020


Application of Wireless Technology in The Pharmaceuticals Sector: Maintaining Data Integrity, Security
Author: Tim Sandle

Good Distribution Practice for Clinical Trial materials
Author: Andrea Zobel

Technical Considerations For Demonstrating Reliability Of Emergency -Use injectors: A Review of Draft
Author: Richard Poska

Regulatory 101: Drug name modifiers – Definition, Categories, Generics, and CAPA
Authors: Natasha A. Barrow, Paul L. Pluta

Audit Trails And Data Integrity In Pharmaceuticals and Life Sciences
Author: Ivan Soto

Compounding Facility Cited For Several Aseptic, Microbiology, And Rapid Methods Issues
Author: Jeanne Moldenhauer

Continuous Culture of CB. Hep-1 Hybridoma Cell In Fifty Days Using A Bioreactor With a Stirring System
Author: Hasel AragĂłn, et. al,

Lessons learned During The Coronavirus – COVID-19 Pandemic
Author: Stacey L. Bruzzese

Consideration of COVID-19 Prevention measures For Those Working in GMP Pharmaceuticals and Healthcare
Author: Tim Sandle

CQV #9: What, how, and Why of Handwashing
Author: Paul L. Pluta

The Survival of Coronavirus SARS-CoV-2 On Surfaces and Designing Disinfection Strategies to Eliminate
Author: Tim Sandle

Vol. 24, Issue 2, Mar 2020


EU GMP Annex 1: What The Final Draft Reveals
Author: Tims Sandle

The Benefits of Contributing to Industry Publications
Author: Paul L. Pluta

The Long Awaited Revision 2 to EU Annex 1
Author: Jeanne Moldenhauer

Annex 1 Revisions, Stakeholder Comment Period, And A Review of Changes
Author: Stacey L. Bruzzese

Selection and Characterization of a Stable Hybridoma Clone for Producing The CBHepBNatural Monoclonal
Authors: Isi Veitia, Reinaldo Blanco, Dany Miranda, Odalys PĂ©rez, Yeleiny MachĂ­n, Duniesky MartĂ­nez, et.al.,

Medication Safety: Epinephrine/Adrenaline Problems, Corrections, and Applications
Authors: Karolina Cieslak and Varanya Chaiyaperm

REGULATORY 101 – Field Alert Reports
Authors: Karen R. Zimm and Renee King-Alliego

Vol. 24, Issue 1, Jan 2020


Pharmaceuticals in the Environment
Authors: Natasa Vukicevic, Aneta Dimitovska, and Jelena Acevska

A Like-For-Like Change Assessment Tool
Authors: Alma O’Reilly and Donncadh Nagle

Application of Validation Principles to the Training Quality System. Part 5 – Training Process
Author: Paul L. Pluta

Ready for the Count? Back-To-Basics Review of Microbial Colony Counting.
Author: Tims Sandle

Building Effective CGMP Training Designed For the Adult Learner
Authors: Lorianne Richter and Nuala Calnan, Ph.D.

Regulatory Actions Taken in Response to Issues in Aseptic Processing and The Quality System
Author: Jeanne Moldenhauer