Pharmaceutical Technology Europe-06-01-2003

The US Food and Drug Administration is working with manufacturers to establish new policies for incorporating genomic information into the regulatory process and simultaneously encourage pharmacogenomic research.

Good laboratory practice (GLP) regulations became effective in 1979 under 21 CFR Part 58 and apply to all non-clinical safety studies intended to support research permits or marketing authorizations. This article introduces some key elements regarding the application of GLP regulations as a quality system and how GLPs are perceived internationally.

Sterilizing grade filters are widely used in the biopharmaceutical industry and were once thought of as being perfect. However, these filters have experienced rapid developments and improvements during the last decade, which have resulted in enhanced thermal and mechanical resistance. Moreover, their performance levels have been raised, which has led to significant cost savings within production processes.

This article examines the application of 21 CFR Part 11 to those areas of research and development (R&D) where compliance is not strictly required and the response of R&D equipment vendors to the rule's requirements and customer needs. The case is presented that vendors must accept that understanding and meeting Part 11 requirements is now part of their business environment.

This article describes a method for assessing the similarity of dissolution profiles using Hotelling's T2 statistic. The method applies a covariance structure that accounts for the heterogeneity of variance and correlation across time points. Comparing the method with the f2 criterion recommended in FDA's guidance on dissolution testing, the performance of the two methods was assessed on real examples, and simulation studies were also done to compare the method's performance with that of the f2 criterion.