The Journal of GXP Compliance
Vol. 25, Issue 6, Nov 2021

Karen R. Zimm
,
Renee Phillips
It is FDA’s expectation that stringent controls to prevent contamination be established. All manufacturers shall understand that pathogens vary among different animal species. Healthy animals can be a source of pathogens, too, and improper handling of materials can spread contamination. Animals from which ingredients are rendered must be healthy...
Paul L. Pluta
This paper continues a series of discussions addressing the application of validation principles to the Training Quality System (TQS). Training process documentation -- specific documentation associated with the actual training of employees -- is addressed. Documents recording training requests, scheduling, and logistics; actual training...
Tim Sandle
The U.S. FDA has issued a new draft guidance document titled ‘Microbiological Quality Considerations in Non-sterile Drug Manufacturing - Guidance for Industry’. The document became active during September 2021. The scope extends to solid non-sterile dosage forms, semi-solid, and liquid non-sterile dosage forms. For the consumer, this represents...
Ratul Saha
The allowable microbial limits are based on the considerations of inherent virulence factors, potential hazard of the organisms, the intended use of the product, the dosage form and its route of administration. The purpose of the allowable limits is to prevent product deterioration and patient risk of infection. However, the compendial methods to...
Jeanne Moldenhauer
Audit trails are critical to compliance activities. In pharmaceuticals, an audit trail is defined as, “An audit trail is a secure, computer-generated, time-stamped, electronic record that, allows reconstruction of the course of an event relating to the creation, modification, and deletion of an electronic record. Numerous Warning Letters issued by...
Paul L. Pluta
This discussion describes compliance events caused by non-technical root causes – attitudes, misunderstandings, resistance to change, conflicting circumstances, and other personal traits in employees in a GMP environment, i.e., elements of culture in the pharma workplace. In these events, organizational culture had strong influence in causing...
Amanda Coogan
Given our current environment, it is no surprise that pharma and device companies are doing everything possible to boost efficiencies. Increasing drug development and production in safe and effective ways, while limiting resources used and dollars spent can be a balancing act. This also applies to clinical trials. Adoption of a risk-based...
Kate Coleman
Join us as we speak with Kate Coleman about the essentials for building a culture of quality while achieving customer satisfaction. Across life sciences, teams concur that quality, defined by safe, effective, and compliant products, is a prerequisite of the pharmaceutical, biomedical or medical device industry. The Quality Management System then...
Jayet Moon
,
Nuala Calnan
In this episode we sit down with Jayet Moon, author of "Foundations in Quality Risk Management" to review some of the key discussion points from his book and share his views on how risk management “is central to the science of prediction and decision-making;” and how “holistic and scientific risk management creates resilient...
This week, Stacey presents the 2021 IVT Awards and interviews the recipients of each award. The awards being presented are Author of the Year for the Journal of GXP Compliance, Author of the Year for the Journal of Validation Technology, Podcast of the Year, Speaker of the Year for Validation Week, Speaker of the Year for Compounding Pharmacy...
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