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IVT - GXP Journal Archive

June 28, 2022

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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 Aragón, 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 Pérez, Yeleiny Machín, Duniesky Martínez, 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

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IVT - GXP Journal Archive

Vol. 26, Issue 2, Mar 2022

Vol. 26, Issue 1, Jan 2022

Vol. 25, Issue 6, Nov 2021

Vol. 25, Issue 5, Sep 2021

Vol. 25, Issue 4, Jul 2021

Vol. 25, Issue 3, May 2021

Vol. 25, Issue 2, Mar 2021

Vol. 25, Issue 1, Jan 2021

Vol. 24, Issue 3, May 2020

Vol. 24, Issue 2, Mar 2020

Vol. 24, Issue 1, Jan 2020

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