The Journal of GXP Compliance
Vol. 24, Issue 5, Sep 2020

Stacey L. Bruzzese
IVT's Validation Week is going virtual for 2020 this October! Not to be confused with a single presentation webinar or zoom training, Val Week 2020 brings a completely virtual, 3-day conference experience. With nearly 30 expert speakers and a combination of live and on-demand sessions crafted with your time in mind, the caliber of training...
Paul L. Pluta
The topic of like-for-like changes and associated problems in a pharmaceutical manufacturing plant was introduced in CQV #2 and continued in CQV #3. Since then, validation and quality managers have submitted additional examples of like-for-like problems they have experienced in their organizations. These new examples of like-for-like problems are...
Tim Sandle
Across time and between different cultures, human have practiced different ways to modify and reshape their bodies (1). Examples include tanning, ear piercing, tattooing, and cosmetic surgery. At the current time of writing, these practices are popular, especially among the younger demographic. These practices carry health (including...
Ivan Soto
One of the most important tools is the DI risk assessment. The DI risk assessment is intended to identify the risk of each system, enabling a risk-based approach to the prioritization of remediation activities. Because the DI tool will be used for prioritizing remediation activities, it is imperative that these tools are objective, developed in...
Tim Sandle
Good Distribution Practice (GDP) concerns the distribution processes for pharmaceutical products that results in medics and patients obtaining access to the medications required. For the pharmaceutical organization, the distribution process occurs both upstream and downstream. Upstream are the suppliers who create goods and services used in a...
Martin J. Lipa, Kevin O'Donnell, and Anne Greene
Quality Risk Management (QRM) and Knowledge Management (KM) have been positioned as co-enablers to the Pharmaceutical Quality System since the 2010 issuance of ICH Q10. Yet these disciplines have remained largely distinct and disconnected in practice. This paper presents a two-part literature review on this topic. First is a review of how other...
Nadia Esani and Joseph Brennan
The outbreak of the coronavirus disease (COVID-19) and the subsequent announcement of a global pandemic in March 2020 has profoundly altered the working day routines of many people. This paper explores how aspects of normal daily working life for the regulatory professional have changed from the pre-pandemic to how it may look post-COVID-19, and...
Paul L. Pluta
Validation Case Studies and Compliance Case Studies are ongoing features in the Journal of Validation Technology (JVT) and Journal of GxP Compliance (JGXP), respectively. These features have provided a forum for validation and compliance professionals to discuss their actual work experiences, problems and solutions that may be helpful to other...
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