JVT Journal Articles
Vol. 15, Issue 2, May 2009

David Fetterolf
Column chromatography is the most common biotech purification process used to separate the target molecule(s) from product and process-related impurities Example types of column chromatography used include anion/cation exchange, reversed phase, and gel filtration Chromatography columns are constructed of glass, acrylic, or stainless steel...
Hydrate is a broad term used to describe the various ways that water can be incorporated into the crystal of a pharmaceutical solid Dehydration of different hydrates requires different amounts of energy The most useful analytical methodologies for studying dehydration are thermogravimetric analysis (TGA), differential scanning calorimetry (DSC...
It is fundamental to ensure that all elements of thermo mapping of control environmental chambers (e.g., refrigerators, walk-in cold rooms, freezers, incubators, walk-in incubators, etc.) are properly designed and qualified with respect to user requirement specifications compliant with current good manufacturing practice (CGMP) standards.
The Question-Based Review (QbR) initiative of the Office of Generic Drugs (OGD) has reached its second full year in 2009. From a human perspective, we can say that QbR has reached “toddlerhood.” And like a true toddler, QbR has come out of its infancy, exploring new ground, trying to define and redefine itself.
ABSTRACT This paper describes a risk-based performance qualification (PQ) concept exclusively based on the fundamental requirements. The result is a cookbook describing a general methodology for deciding the size and number of PQ runs needed. The fundamental philosophy is that PQ must simulate normal production, including the challenges...
The US good manufacturing practices guidelines for finished pharmaceuticals (GMPs) (1) were formally introduced in 1963 (2) based upon the best practices of the US Food and Drug Administration regulated activities. In the 1970s, the GMP guidelines were significantly revised, acknowledging the use of computer systems performing operations covered...
Ed White
Aseptic processing is inherently risky.
A validation master plan (VMP) is more than a plan for validation; it is a commitment from the organization to achieve compliance during validation A VMP is a forward-looking document that must contain a plan for maintaining the validated state of systems after initial qualification Every VMP should contain three general commitments: a...

CHROMacademy Video Training Courses