In the past few years, there has been a change in emphasis by regulatory and compendial
requirements to require that pharmaceutical manufacturers verify the accuracy of the thermal …

Marketed drugs and devices possess specifications including critical microbiological quality
attributes purposed to assure efficacy and patient safety. These attributes are legislated …

The quality of a commercial pharmaceutical product is set by a well-designed, understood,
and executed manufacturing process using high-quality raw materials. In addition, this built …

Life science firms in the US are currently subject to two different process validation
standards: the GHTF's Process Validation Guidance and the FDA's Process Validation …

The US Pharmacopeia (USP), the Japanese Pharmacopoeia, and the European
Pharmacopoeia" Microbial Limits Tests" are in the final stages of harmonization. The …

In the first part of this article Bis are closely examined regarding their constituents, attributes,
and problems. The idea is developed that Bis are accurate measuring units when properly …

BaCKGrounD At the preformulation stage of product development, estimates of chemical
and/or physical stability are normally derived from accelerated stability tests and occasional …

Spanning every critical element of validation for any pharmaceutical, diagnostic, medical
device or equipment, and biotech product, this Second Edition guides readers through each …

In fiscal year 2000, the University of Texas Health Science Center at Houston (UTHSC-H)
Biological Safety Program began systematically assembling data on a monthly basis that …

ABSTRACT A decision scheme for determining the capability of a finished product dosage
form to be terminally sterilized was presented and followed for a heat-sensitive, oxygen …