The Journal of GXP Compliance
Vol. 18, Issue 3, Aug 2014

Alan M. Mancini
Joanne Wong
Paul L. Pluta
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
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
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
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
An IVT Microbiology Week think tank was held in Philadelphia, PA, USA in August 2014. Participants were asked to submit responses to the following questions in preparation for the session: What do you consider the most challenging task currently on your “to do” list? What area of microbiology is your greatest concern? Any fears or concerns...
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.
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