The Journal of GXP Compliance
Vol. 25, Issue 2, Mar 2021

Tim Sandle
A contamination control strategy is a system that considers all the integral elements of pharmaceutical product manufacturing. This is best achieved using quality risk management principles and supporting risk assessments for contamination control and monitoring. An effective strategy is needed. It is recognized that any contamination control...
Greg Vanderstel and Kim Huynh-Ba
There is a disturbing increase of warning letters found concerning data integrity in recent years, mostly contributed to methods the data are recorded and evaluated. Good Documentation Practices present five main components of data integrity, often abbreviated as ALCOA: attributable, legible, contemporaneously recorded, original or a true copy,...
Alan M. Mancini
,
Paul L. Pluta
A case study involving unexpected green and brown spots on a previously problem-free white tablet product is described. Interaction between trace impurities in talc (formulation ingredient) and the tablet press punch lubricant, combined with worn dust cups used in the tablet compressing process were determined to be the causes of the spots. A new...
Richard C. Wedlich
,
Z. Miller
Safety management strategies are used to assess and mitigate hazards in the chemical laboratory and to minimize and accept the associated risks. One such strategy, system safety analysis, is presented in some detail using a hypothetical example. While a large number of strategies exist, they all boil down to common sense. Know what you are dealing...
Karolina Cieslak
,
Paul L. Pluta
A drug may be known by different names during its development and commercial lifecycle. “Regulatory 101” has previously discussed categories of drug names – chemical, non-proprietary (generic), and proprietary (1). This previous discussion provided general overview and concepts applicable to both small molecule and biologic (large molecule) drug...
Seth Robinson, Paul Lopolito, Elizabeth Rivera, Beth Kroeger-Fahnestock
This paper presents a new approach for decontamination of non-product contact surfaces with a globally available quaternary ammonium disinfectant. Laboratory studies included liquid and surface decontamination of various cephalosporin antibiotics. This approach will drastically reduce the likeliness of corrosion caused by an acidified sodium...
Paul L. Pluta
,
Stacey L. Bruzzese
Management Roundtable is a new IVT feature that will provide quality and validation managers a mechanism to share information about how they manage their function responsibilities. This forum will address non-technical function management including contemporary personnel topics. Management topics are rarely addressed at technical professional...
Paul L. Pluta
This review describes the recently-published Principles of Parenteral Solution Validation, A Practical Lifecycle Approach, edited by Igor Gorsky and Harold S. Baseman. This book is part of the Expertise in Pharmaceutical Process Technology series published by Academic Press (Elsevier) and edited by Michael Levin. Igor Gorsky is a member of the...
Tim Sandle
Many workplaces within the pharmaceutical and healthcare sector have put in place thermographic camera scanners on building entrances in order to reduce employee contact where one employee may have the SARS-CoV-2 virus (the coronavirus) and is exhibiting symptoms associated with the disease that the coronavirus can cause COVID-19. These devices...
Roberta Goode
Patient safety is the primary concern in medical packaging. When we think about packaging, we may immediately be concerned with straightforward patient communication and transparency. However, patient safety in packaging starts way before the words are ever printed on the package or label. Today we are going to discuss the nuts and bolts around...
Paul L. Pluta
Far too often we hear of unanticipated illness and even death due to unexpected effects of ingredients in the foods or medicine we consume. Sometimes these are deliberate, with people consuming more than prescribed or mixing medications. But sometimes these are unintentional, with catastrophic impacts such as the case of the black licorice. The...
Lorianne Richter
,
Nuala Calnan
,
Randy Friedman
Bias in its simplest form is a tendency to lean either in favor of or against a particular thing, while heuristics is an approach to problem solving that uses a limited experience or various shortcuts to arrive at an outcome. Both of these innate tendencies can impact our ability to identify and assess risk, as well as impact our decision making...
Ginette Collazo, Ph.D.
To err is human, but is human error a justified cause in GMP investigations? In pharmaceutical manufacturing, upwards of 80% of process deviations can be attributed to human error. While regulatory agencies make clear that all deviations, including those caused by human error, must be fully investigated can we say that we are effectively doing...
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