GXP Journal Articles
Vol. 18, Issue 3, Aug 2014

Alan M. Mancini
,
Joanne Wong
,
Paul L. Pluta, Ph.D.
This case study was provided to the Journal of GXP Compliance by a reader who requested anonymity. The event described is an actual occurrence. A small molecule pharmaceutical company developed a stable metronidazole solution product for IV administration. The product was successfully manufactured with minimal technical or clinical problems for...
Crystal Booth
The antimicrobial effectiveness test (also known as the preservative effectiveness test) first appeared as a USP General Chapter in the 18th revision, official September 1, 1970 (3). International harmonization has not been completed to date. The United States Pharmacopeia (USP), Japanese Pharmacopeia (JP), and European Pharmacopeia (EP) all...
Tim Sandle, Ph.D.
This article provides an introduction to the sanitization and bio-decontamination of pharmaceutical manufacturing facilities. This topic is especially relevant for manufacturing of sterile products. Pharmaceutical facilities used for manufacturing of sterile products are comprised of a series of rooms called cleanrooms. Cleanrooms and zones...
Tim Sandle, Ph.D.
Ophthalmic preparations (eye preparations) are sterile liquid, semi-solid, or solid preparations that may contain one or more active pharmaceutical ingredients. Ophthalmic products are intended for application to the conjunctiva, the conjunctival sac, or the eyelids. The course of treatment may extend during several days. Although eye...
Paul L. Pluta, Ph.D.
This case study was provided to the Journal of GXP Compliance by a reader who requested anonymity. The event described is an actual occurrence. The compliance event involved cleaning validation for cleaning of residue from a small molecule tablet dosage form. The active ingredient in the tablet was a potent drug – dosage of the active...
Karen Ginsbury
Industry meetings conducted by the IVT Network have recently included a “Senior Level Think Tank” session on the respective topic for the meeting. These sessions have become a major feature at IVT conferences. They are frequently requested and well-attended by conference participants. Attendees generally have a sound technical background and...
Carol Brandt
GMP audits are an important activity in a site compliance program.An organization that initiates a GMP audit has clear objectives and expectations for the audit.A significant amount of time, personnel effort, and cost is expended in a GMP audit.Audits that are properly planned, structured, and executed should yield maximum benefit to the...
Jerry Lanese and Timothy J. Fields, editors
A Column for Discussion of Issues Identified by Readers of the Journal of GXP Compliance and the Current Good Practice for Resolution of the Issues
Ivan Soto
The cost of validation has become an important topic in the pharmaceutical industry in recent years. This is due to concepts introduced in guidance documents such as ASTM E-2500 and GAMP 5. These documents promote a risk based approach including integration and elimination of duplicate validation activities.