GXP Journal Articles
Vol. 12, Issue 1, Oct 2007

Ludwig Huber
This article describes how FDA's regulation for Elec- tronic Records and Signatures 21 CFR Part 11 has been developed over time. The regulation was released in 1997. With FDA's early interpretation and enforcement, the cost for industry to implement Part 11 had been too high. The FDA changed the approach in 2003 with the release of a new...
This article is one of a continuing series in which representatives of the industry and the regulatory agency have an opportunity to express opinions on current GXP issues.
Steven S. Kuwahara
Incoming water can easily be a source of contami- nants that will appear in products, and this issue has been addressed in the GMPs. Although initially found as a brief statement in 21 CFR 211.48(a), the need for potable feed water in pharmaceutical manu- facturing establishments creates requirements that must be understood by the QC/QA worker....
Gordon Welty, Ph.D.
Employees in regulated industries must be trained before they “touch” the product. According to the Food and Drug Administration (FDA), the “person” must have the “education, training, and experience, or any combi- nation thereof, to enable that person to perform the assigned functions.1” This requirement has substantial implications for both...
The powder blending process has been historically identified as a challenging operation in Oral Solid Dosage (OSD) form manufacturing. Insufficient blending results in poor active ingredient mixing with excipients. Excessive blending could adversely impact the distribution of drug content (content uniformity) in the final product. Companies suffer...
The Drumbeat system for classifying Good Manufacturing Practice (GMP) activities into “Concepts” developed by Kenneth Chapman of Pfizer in the late 1970's and throughout the 1980's has been used as a basis for organizing company policy in a tabular form which includes defining responsibilities. Techniques are suggested for making...