Heating, ventilation, and air conditioning (HVAC) and associated engineering technologies are topics of great importance in contemporary pharmaceutical and medical device manufacturing. These systems comprise multiple components that are integrated in a reliable process to create a sustainable environment. Compliance professionals must have reasonable knowledge and understanding of the products, processes, facilities,...
The validation of dissolution methods can be more complicated than validation of other methods such as assay or content uniformity because both the dissolution process and the determinative step need to be characterized. Validation requirements are firmly established in International Conference on Harmonisation (ICH) guidelines, regulatory...
The proper training of personnel involved in aseptic processing is crucial. This paper outlines a variety of methods that may be applied to training in aseptic operations.
There are a variety of microbial identification technologies on the marketplace available to the quality control laboratory. The choice of which technology to use is one that must be approached with a firm grounding in the requirements of the facility for cost, turnaround time, capacity, level of identification, and many other considerations....
The one fact that most people remember incorrectly from that long ago statistics class is the rule of thumb Xbar ± 3S. Thus, we have the incorrect but common practice of using the sample average plus and minus three times the sample standard deviation as a solution for finding confidence intervals, setting alert criteria, identifying outliers,...
Envision a perfectly smooth, solid, uniform cube of length, width, and height all 10 meters (see Figure 1). There are six surfaces: the top, the bottom, and four sides. The area (length × width) of each surface is 10m × 10m = 100m2. Therefore, the total area of all surfaces exposed to the environment is 100m2 × 6 = 600m2. This is the cube’s...
DownloadCommentary: Designation of Regulatory Starting Materials in the Manufacturing of Drug Substances - Impact...
The generic drug market has become increasingly competitive. The need for cheaper drugs in the American marketplace has driven the abbreviated new drug application (ANDA) submissions to staggering numbers, which in turn has lead to increasingly longer US Food and Drug Administration review and approval times.
“GXP Talk” discusses issues identified by readers of the journal and provides current good practice to resolve those issues.
DownloadThe Business of Auditing and Auditing the Business: Part Three: Quality Responds to the Audit
Welcome to the third article in the series “The Business of Auditing and Auditing the Business.” This article continues to explore the elements of the quality audit (including the emotional components) as we see how an experienced quality professional in a changing business manages an evolving audit situation.
