JVT Journal Articles
Vol. 16, Issue 1, Feb 2010

This article describes the shipping qualification process used for the international transport of a vaccine drug substance in flexible containers (FC) from the United States. The drug substance is produced in the US and dispensed into two-liter (2L) FCs. The FCs may subsequently be transported internationally for vaccine formulation and filling into syringes.
The following key points are discussed in this article: A clear statement of requirements is fundamental to determining what you want and what you need Write your requirements so they are unambiguous, complete, consistent, and testable The quality of your computerized system will be a direct result of getting quality requirements written All...
The following key points are discussed in this article: Aseptic process simulation (media fills) is the lynchpin of any qualification of an aseptic facility Aseptic process simulations should be carefully planned to ensure the length of the simulation and the number of manipulations performed during the fill are representative of the actual...
The following key points are discussed in this article: A validation case study involving fundamental problems in equipment qualification at a drug product packaging facility is discussed.
The original intent of the 21 CFR Part 11, pertaining to the use of electronic records and signatures, was to encourage industry to adopt new technologies, but the regulation turned out to have a totally opposite effect. The revision of its guidance documents and the continuous redirection of this rule do not end the confusion and discussion of...
The following key points are discussed in this article: There is a right way and a wrong way to control chart Always start the analysis of data by looking at the trend over time Make sure that the metric being analyzed is the best way available to represent the direct variation of the system Data are gold. Make sure you use all the available...
The following key points are discussed in this article: Selection of individual unit operations for a pharmaceutical water system providing bulk compendial water should be based on a thorough analysis of chemical, microbial, and physical parameters of the feed water supply.
The following key points are discussed in this article: Quality control (QC) microbiology test data are subject to significant variability, both avoidable and unavoidable Good microbiological procedures, backed by sound microbiological practices, can serve to minimize avoidable variability The lab’s standard operating procedure (SOP) system...
The following key points are discussed in this article: Medical device research and development under the US Food and Drug Administration’s design control requirements is discussed The majority of serious device problems are introduced during the design and change phases of development Design control and design history file (DHF) requirements...
The maximum acceptable carryover (MAC) criterion is widely used to set cleaning validation limits for contaminants. It is based on the assumption that all the residual contaminants in the cleaned equipment will carryover into the next batch that is manufactured in that equipment. Thus, the MAC criterion is based on a worst-case mass balance (...
The following key points are discussed in this article: Dissolution is an essential step in the drug absorption from solid products. In vitro dissolution is primarily a function of drug solubility, the dosage form design, and the testing methodology and conditions There are different mathematical models that describe dissolution phenomena...
The following key points are discussed in this article: Wetting is an important phenomenon in the manufacture of pharmaceutical dosage forms Wetting is also related to drug dissolution, drug bioavailability and in vivo performance—the efficacy of the drug product Wettability of a solid is dependent on the nature of the functional groups on...
The following key points are discussed in this case study: A validation case study involving equipment cleaning and inspection of cleaned equipment is discussed The event comprised of cleaning multiple equipment per procedure. Manufacturing residue was observed in only one specific piece of equipment after cleaning The following three issues...