The Journal of Validation Technology
Vol. 27, Issue 3, Jun 2021

Tim Sandle
Women make up the majority of the workforce in pharmaceuticals and healthcare globally, yet the distribution of pay, other benefits, scientific standing, representation in leadership positions, and access to certain occupations, is highly disproportionate. Some progress is being made, especially with more women occupying higher positions within...
David Harris
Senior Leadership has to make hard decisions about investments. We see headlines about mergers, acquisitions, partnerships, opting in on products that have exciting development or preclinical results. The headlines may also include significant investment in internal infrastructure. Hundreds of millions of dollars may be directed to building a new...
Ivan Soto
Commissioning, Qualification, and Validation (CQV) has undergone dramatic changes and challenges over that last couple of decades driven by competing priorities, misperception about global regulatory requirements, and fear of change. Several guidances and standards have been published to provide ideas and approaches to the implementation of an...
Paul L. Pluta
Validation documents are key documents in a pharmaceutical manufacturing facility. Validation documents must be carefully written for internal and external review including audit by regulatory inspectors; they may be accessed numerous times during a product lifetime. The most frequently reviewed validation documents are Stage 2 Process Performance...
Andrew Treller
To combat CSV non-compliance, established here are cost and time effective explicit methods to verify and validate Microsoft Excel Workbooks designed to meet standards set by Australian regulatory bodies: The Therapeutic Goods Administration (TGA) and Pharmaceutical Inspection Co-operation Scheme (PIC/S).
Tim Sandle
Respiratory droplets are coronaviruses primary transmission mode and thus the majority of coronavirus risk mitigation strategies focus on the control of air. However, surface contact remains an alternative infection route. Hence, it remains a concern that the SARS CoV-2 virus can remain viable on surfaces for several hours.
Ana Aguilera, José López, Gipsy Baro, José Marcelo, Yilian Bermudez, Rodolfo Valdés, Lourdes Costa
This study validated a sensitive and accurate sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE) method to determine purity of recombinant Streptokinase (rSK) extracted from suppositories applied for treating hemorrhoidal disease. The initial treatment of this disease is based on hygienic-dietetic and symptomatic measures, in...
Tim Sandle
Microbiological methods are less precise than analytical ones, even with the advent of rapid microbiological methods. Microbiological samples are often less representative of what is actually present in a sample, and are generally less accurate than chemical ones, due to the variations with the distribution of microorganisms in the environment. In...
Tim Sandle
While some animal testing may, in special circumstances, continue to have a need for the determination of safety in pharmaceuticals, strides are being made in replacing many animal tests with laboratory tests. One such area where progress has been made, and where further action is required, is with the case of the general test for toxic products....
Alan M Golden
,
Becky Leibowitz
,
Kurt L. Moyer
,
Roberta Goode
Combination products are everywhere. As increasingly more enter the market we are continuously questioning the unique strategies necessary for development of a product across multi-disciplinary teams. Staying up to date with changing patient needs, monitoring emerging global regulatory requirements and efficiently delivering high-quality products...
Karen R. Zimm
,
Paul L. Pluta
A drug may be known by different names during its development and commercial lifecycle. Medication safety problems associated with drug names have long been recognized as a significant problem by healthcare professionals. Whether it's look alike or sound alike errors, drug modifier misidentification, or proprietary vs. non-proprietary...
Lorianne Richter
,
Nuala Calnan
,
Tiffany Baker
This week on Risk Revolution Series coordinators, Lori and Nuala, invite their guest Tiff Baker to chat about FACILITATORS. ARE THEY FRIEND OR FOE? Listen as we dive in on the importance of facilitation in the risk management process and how it leads to the success of a risk assessment.
Alex Viehmann
,
Carla J. Lundi
,
Jennifer Maguire
,
Lyle Canida
,
Nandini Rakala
Hear from FDA members, Jennifer Maguire, Nandini Rakala, Alex Viehmann, Carla Lundi, and Lyle Canida. Stacey and the team from the FDA discuss the FDA announced innovative Quality Management Maturity Pilot Programs for Manufacturers of Drug Products and Active Pharmaceutical Ingredients. Results of this pilot program are intended to aid in the...
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