JVT Journal Articles
Vol. 18, Issue 3, Aug 2012

A new approach is being tested for the microbiological monitoring of aseptic environments, and improvements are being written in guidance for sterility assurance, as part of an active response to industry by United States Pharmacopeia (USP) to be current and align with quality by design concepts. Regulatory scrutiny demands for fit purpose concepts that incorporate current thinking, updated technology, and better...
Willis H. Thomas
Conference attendees recently identified the most important competences for computer and software validation (CSV) projects. The response revealed that the most important skill is communication. Project management was identified as the second most important skill, followed by technical knowledge, regulatory knowledge, and process/analytical skills...
William V. Collentro
Inline ultraviolet sanitization units emitting radiation at a wavelength of 253.7 nanometers (nm) have been used for several years in compendial water systems. Use of 253.7 nm radiation does not destroy bacteria but inhibits replication by modifying deoxyribonucleic acid (DNA) and ribonucleic acid (RNA). Radiation at 184.9 nm at much higher...
Assessment of the viable population among the total biomass is critical for determining the quality of the starter culture as well as monitoring of the fermentation process. Culture-based plate counting traditionally assesses viability. Flow cytometers can determine cell number and characterize cell size, shape and granularity based on its light-...
Janis V. Olson
Software test tools are very useful for development, validation, and maintenance of computer systems in regulated industries and can absolutely be used. Key aspects in an approach for use of these tools are provided. Two examples of tools are described. The use of software testing tools will increase the quality of software applications by...
Abby Spencer
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Michelle J. Horner
Biopharmaceutical cleaning and sterilization cycles are designed to expose product contact equipment to pH and temperature extremes. Under these conditions biological products tend to become pharmacologically inactive. This paper describes a methodology for assessing inactivation during cleaning and setting acceptance limits based on inactive...
Joseph Busfield
Facilities governed by current good manufacturing practices (cGMPs) must remain in a validated state. The site preventive maintenance program is a critical part of this effort. Requirements for equipment are stated in 21 Code of Federal Regulations (CFR) 211.67. All facility, process, utility, and laboratory equipment used in the manufacturing,...
William R. Porter, Ph.D.
Achieving stability by design requires, as one component, the exploration and establishment of boundaries for a storage temperature design space. The kinetics of degradation of a drug or drug product can be predicted using the Arrhenius model for the dependence of reaction rates or shelf life on reciprocal absolute temperature. This is easily done...
John E. Lincoln
Medical products are governed by a quality management system (QMS) defined by the United States Food and Drug Administration in 21 Code of Federal Regulations (CFR) 820. The current good manufacturing practice (GMP) requirements set forth in the quality system (QS) regulation are promulgated under section 520 of the Food, Drug and Cosmetic (FD...
Michelle C. Killilea
On June 6, 2007, three hospitals in China reported to Chinese Ministry of Health (MOH) and Chinese State Food and Drug Administration (SFDA) that patients undergoing intrathecal methotrexate therapy for leukemia and lymphoma developed severe paraplegia and paresis. Paraplegia is the impairment or complete loss of motor and sensory function in the...

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