The Journal of Validation Technology
Vol. 19, Issue 2, Jun 2013

In the first half of Dawn Tavalsky's formally titled "Validation Boot Camp — A Lifecycle Approach to Pharmaceutical Validation — Principles, Implementation and Practice," Dawn Tavalsky discusses the history of good manufacturing practices (GMPs) and process validation, three case studies of GMP violoations (IV bottle contamination, hemodialysis filters, albuterol inhaler), and the basics of installation...
Scott Sutton, Ph.D.
The measurement of microbial kill requires the ability to measure the number of surviving microorganisms with time after exposure to the antimicrobial agent. Bioburden determinations have the same requirement as they depend on the ability to recover viable microorganisms in the presence of potentially antimicrobial products or raw materials....
Isso Bayala, Ph.D.
Theodore Canty
The combination of clean steam and weak sodium hydroxide (0.1M NaOH) solution has proven to be a very effective method for cleaning surfaces and equipments in a good manufacturing practices (GMP) compliant environment. The treatment of floors and equipments of a cleanroom with clean steam alone was able to remove up to 80% of stains including dirt...
Bernard McGarvey
Brian K. Nunnally
John McConnell
One common pitfall in decision-making is the incorrect use (abuse) of data. It is common to hear scientists talk about using data to make decisions, but it can be rare to see it employed correctly. This paper tackles the use of data from a different perspective, its abuse. Five abuses of data and the potential outcome of the abuse are detailed....
William R. Porter
Achieving stability by design for solid products requires, as one component, the exploration and establishment of boundaries for a storage temperature × relative humidity design space within which the kinetics of degradation of a solid drug or drug product can be predicted using an extended Arrhenius model for the dependence of reaction rates or,...
Tim Sandle
The phenomenon of bacterial adhesion is an important phenomenon for those working within the pharmaceutical and healthcare sectors to consider. This is because many processes are centred on the removal of bacteria, be that from pipework in water systems or from surfaces within cleanrooms via cleaning and disinfection regimes. The adhesion of...
Denise Dion
The US Food and Drug Administration’s Quality System Regulation (Code of Federal Regulations Title 21 Part 820) uses the terms verification and validation (V&V) in several sections. V&V are required as part of designing and developing a medical device, as part of implementing a manufacturing production process or an automated system, as...
Frank Jacquette
Cloud computing in the life sciences industry grew dramatically in 2012, and the trend will gain speed in 2013. The cloud offers many benefits, but it’s not without its disadvantages. To best manage those risks, you must first understand them, so here are the top concerns to consider when going to the cloud.
John E. Lincoln
FDA has already reviewed (in 2011) whether AEDs should be reclassified downward to Class II and/or be cleared for marketing under the 510(k) program. However, due to past actions by industry in AED adverse events reporting under Medical Device Reporting (MDR)/Adverse Events as well as recalls not being successful according to FDA, hence the...
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