Computers and computerized systems are an integral part of daily life in the laboratory. Examples include: laboratory equipment, Laboratory Management Information System (LIMS), the network, servers, databases, and individual workstations, all providing remote access to important data. Government rules, regulations and guidance documents contain specific requirements for computerized systems. One of those regulations is Good Clinical Practice (...
At base, our focus is the relationship among GCP, the auditing process, and Institutional Review Boards (IRBs). In addition, we...Download
Not all medical devices require clinical investigation in order to demonstrate their safety and efficacy. But, even for some...Download
This article outlines structural and ethical considerations of clinical trials registries and databases of results. The topic...Download
DownloadA Case Study for Qualification of a MALDI-TOF System for use in a Two-Tiered Approach to Microbial Identification
The MALDI-TOF is a rapid identification system that identifies microorganisms by creating a finger print of highly abundant proteins that is compared to a library of known species to produce an identification result to the genus or species level. A comprehensive and well-structured Laboratory Equipment Qualification Program (LEQ) facilitated the qualification and implementation of a MALDI-TOF...
Aside from aspects of the technology used, the world of Good Clinical Practices (GCPs) is one of human complexity and interpretation. While it may not as obviously lend itself to methods of validation with which our colleagues in laboratory, manufacturing, and packaging environments are so familiar, the primary concerns are indeed the same: to verify the essential processes and procedures that...
In this study, the root cause of a staining phenomenon observed during cleaning studies performed using a specific lot of ethylene propylene diene monomer (EPDM) rubber coupons was investigated. Scanning electron microscopy and stereomicroscopy were employed to understand the mechanism of staining. Results suggest stains were artifacts of the reflective properties of the EPDM surfaces being...
This paper discusses the MALDI-TOF technology and outlines the advantages and disadvantages with the system. Microbial identification plays an important role in pharmaceutical processing. Microbial identification can be defined as "microbial characterization by a limited spectrum of tests pre-chosen and appropriate to the problem being studied.”
DownloadLinking Simulation and Risk Approach for a Bulk Vaccine in Clinical Phase— Part I. Effect of Interventions
Human-borne contamination is well known to be the most critical risk factor in aseptic processing (1, 2). Interventions are defined as operations where previously sterilized products, containers, or closures are exposed to human activity. Interventions can be classified as routine and nonroutine. Routine interventions (RI) are activities that are inherent parts of the aseptic process performed...