The Journal of GXP Compliance
Vol. 24, Issue 3, May 2020

Tim Sandle
In the article, some of the general risks in relation to data security, cyberattacks, data privacy, signal disruption, and data integrity are considered, alongside the specific risks that come with the application of Wi-Fi. For the most part these risks can be mitigated, provided appropriate protocols are adhered to enabling the benefits of Wi-Fi...
Andrea Zobel
The commercial supply chain of medicinal products is different from the clinical supply chain, which is set up individually for each clinical trial. This article highlights the main differences between the commercial and the clinical supply chain, and each investigational product individually. IMPs (Investigational Medicinal Products) are not...
Richard Poska
The FDA previously published Guidance for Industry: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products (1) in 2013. This document provided guidance on injector design, materials of construction, performance testing, sterilization, and labelling. FDA has now drafted Technical...
Natasha A. Barrow
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Paul L. Pluta
Drug name modifiers are descriptive components of proprietary drug names. Drug name modifiers are letters, words, numbers, or combinations thereof that describe a unique product characteristic as part of the proprietary drug name. Examples of drug name modifiers include PM in Tylenol PM®, SR in Wellbutrin SR®, D in Claritin-D®, HFA in ProAir HFA...
Ivan Soto
This article will expand and cover in more details the topics discussed in the Voices of Validation podcast from January 2020 and will further discuss strategies about how to implement a risk-based data integrity and audit trail reviews process.
Jeanne Moldenhauer
Since the FDA was granted authority to inspect 503(b) Compounding Centers, there have been a number of FDA-483 observations and Warning Letters issued. While compounding centers have been quicker to implement rapid microbiology methods (RMMs), likely since their products are used in a short period of time post manufacture, they also have been...
Hasel Aragón, Marcos González, Grechen Menéndez, Daily Hernández, Williams Ferro, David Goitizolo, Tatiana Álvarez, Yanet Villegas, José García, Tatiana González, Regla Margarita, Maiylín LaO, Andrés Tamayo, Rodolfo Valdés
Since mammalian cells were isolated and cultivated under controlled conditions; several bioreactor types, operation modes and culture media have been assessed to obtain products with the highest purity and yield. In such sense, the Lambda-MINIFOR bioreactor uses an unusual vertical stirring system for maximizing the mixture of gases and nutrients...
Stacey L. Bruzzese
These past weeks have become a test in global resiliency, solidarity, creativity and good old fashioned grit. As the COVID-19 pandemic spread across the globe challenging community leaders to close, businesses, schools, shopping centers, restaurants and parks, citizens self-isolated in an effort to flatten the curve. Under stay at home orders many...
Tim Sandle
<p>The novel coronavirus SARS-CoV-2 (causative agent of the disease COVID-19) triggered a global pandemic in 2020, leading to a raft of government-imposed measures designed to slowdown the rate of infection, in order to reduce the pressure upon health services. While many parts of the economy shutdown, most pharmaceutical and healthcare...
Paul L. Pluta
<p>Handwashing, or hand hygiene, has become fundamental in modern life. Personnel working in regulated industries including pharmaceutical, medical device, food service, and others have been educated on the importance of handwashing for many years. Healthcare workers, especially with direct patient involvement, are also very well trained in...
Tim Sandle
The novel human coronavirus, named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (1), and which emerged in Wuhan, China, in late 2019 and led to a global pandemic (2), presents a concern to all people and economic sectors, including pharmaceutical and healthcare facilities. Part of the concern relates to SARS-CoV-2 having the...
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