OR WAIT null SECS
July 02, 2004
The limitation-of-risks (LR) method can be used as an engineering tool in risk assessment work for the identification, minimization, and evaluation of potential airborne risks, and for the identification of adequate monitoring points.
The authors outline stability studies designed to evaluate the effect of temperature excursions on product quality that may occur during distribution.
June 02, 2004
The role of microbial testing to ensure the sterility of aseptically filled sterile products is explained, from the product development phase to in-process monitoring to finished product testing.
Pharmaceutical Science & Technology News
A recent USP gathering generated creative suggestions for the March 2005 USP convocation.
May 02, 2004
The author describes a separation method for two active ingredients in the contraceptive pill with liquid chromatography UV detection.
May 01, 2004
Total organic carbon (TOC) analysis is a fast and effective analytical technique for cleaning validation. Understanding the various types of TOC technologies is essential for choosing the best solution.
FDA expects a firm that is subject to GxP to develop a risk evaluation of its product and to then mitigate the identified risks. Identified risks may be addressed by technical fixes that effectively eliminate the risks or reduce the likelihood of occurrence and/or severity of consequences to acceptable levels.
FDA's draft guidance on aseptic processing contains some inherent difficulties, including unrealistic expectations of sterility and microbial quantification, an absence of harmonization with international rules, and failure to support new technologies or a risk-based approach. The authors propose a science-based alternative.