The Journal of GXP Compliance
Vol. 12, Issue 4, Jul 2008

Patricia L. Smith
Sampling individual units at random is well defined in classical statistical sampling theory. With bulk materials (e.g., solids, liquids, gases), however, individual units cannot be enumerated; a group of neighboring units is extracted at once; and the portion identified to be the sample cannot be recovered exactly. Random sampling in these cases...
David LeBlond
Good decision-making is a key element in the assurance of pharmaceutical product safety and efficacy throughout the product life cycle. Good decisions require process knowledge. Process knowledge consists of a statement of a predictive model for the process plus estimates of the underlying model parameters. Three types of estimates are identified...
Gordon Welty, Ph.D.
This article is the sixth in a series on training and the ADDIE Model.
This issue of “Global Regulatory Viewpoint” discusses self-inspection programs in the pharmaceutical industry and associated considerations with Kevin O’Donnell of the Irish Medicines Board. Note: The views expressed in this paper are the personal views of Dr. O’Donnell and are not necessarily the views of the Irish Medicines Board.
This paper assesses the three common vibrational spectroscopy technologies, mid-infrared (MIR), near-infrared (NIR), and Raman, for rapid at-line and/or offline chemical identification testing of raw materials in a current good manufacturing practice (CGMP), quality control laboratory. Respective spectra of about 33 pharmaceutical raw materials...
Michael H. Anisfeld
The label on a pharmaceutical product gives vital information to the practitioner, pharmacist, and patient using the product. If incorrect information is provided, or the wrong label is affixed to the product, the patient’s life is put at risk. Therefore, an audit of a pharmaceutical manufacturing company’s labeling operations is imperative.
Human-borne contamination is well known to be the most critical risk factor in aseptic processing (1, 2). Interventions are defined as operations where previously sterilized products, containers, or closures are exposed to human activity. Interventions can be classified as routine and nonroutine. Routine interventions (RI) are activities that...
Jackelyn Rodriguez
The US Code of Federal Regulations Title 21 CFR§820.30 Design Controls (1) requires that “Each manufacturer of any class III, class II, (and some specified class I devices) shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.” Also, medical device manufacturers...
This article is one of a continuing series in which representatives of the industry and the regulatory agencies have an opportunity to express opinions on current GXP issues. Thank you for your responses to Questions 18 and 19 posed in the last issue of JGXP. The questions are repeated below and the responses follow.
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