GXP Journal Articles
Vol. 11, Issue 4, Jul 2007

A current popular aphorism in Food and Drug Administration (FDA) regulated pharmaceutical and biotech arenas are the words, ‘risk management.’ They are being used by regulated pharmaceutical and biotech manufacturers worldwide, as well as by standards developers and regulatory agencies whose primary focus is on the safety and efficacy of regulated...
Here the name of the game is remediation for compliance. The Part 11 requirement has not changed, however, its interpretation and enforcement has in light of the new Food and Drug Administration (FDA) guidance document. For us, what was begun, is now being completed. A task force was assembled in order to create a matrix to apply the legislation...
Soaring drug development costs, patent expiration, and reduction in the number of blockbuster drugs are driving pharma companies to look seriously at Information Technology (IT) enabled productivity. The pharma IT strategy must be strengthened to better support business needs. The traditional approach of “working for business” is evolving into a “...
In this paper, a brief introduc- tion of Chinese GMP with respect to legislation, guidelines, and the GMP certification system is given. This is followed by a comprehen- sive comparison of Chinese GMP with international GMP – ICH Q7, covering the main aspects of GMP starting point, product quality management, personnel, buildings and facilities,...
Gordon Welty, Ph.D.
The ADDIE model is a generic instructional design model. It provides guidance at a fairly high level for instructional designers, software engineers, etc., as they author and revise learning products. The phases of the ADDIE model are Analyze, Design, Develop, Implement, and Evaluate.
John E. Lincoln
Until recently, the taking of vitamin or mineral supplements, and especially herbs, was considered to be at the fringes of respectability by mainstream medicine. However, by 2005 the nutraceutical and dietary supple- ment industry had become a $182 billion global market, and a $20.3 billion U.S. market, growing at 2.6 % annually.1 An important...
This article provides a suggested procedure to be followed by a company from the time a potential tampering incident regarding a drug, biologic, medical device, or consumer health care product is received until the time that the incident is resolved as a common customer complaint or it is submitted to a higher level Management Representative for...
Thank you for your responses to questions 10 and 11 that appeared in the last issue of the Journal of GXP Compliance. The questions are repeated and their responses follow