JVT Journal Articles
Vol. 18, Issue 2, May 2012

There are several important factors that must be considered in the design, operation, and maintenance of compendial water systems. Storage systems are one of these important factors. This article provides a summary of parameters that should be considered for both plastic and stainless steel storage systems.
Process validation is a key part of the quality system for medical device manufacturers. Complying with regulatory requirements is important to obtain premarket approvals and premarket notifications for new and modified medical devices. Simple, but essential, roadmaps assist in making decisions about which processes require validation, how and why...
Harry Yang, Ph.D.
Shelf life of a drug product is often determined based on a confidence interval approach recommended in the ICH Q1E. Several alternative methods such as prediction and tolerance intervals have been proposed in literature, aiming at providing greater product quality assurance. Some researchers even suggested that regulatory authorities adopt the...
Ragine Maheswaran
A well-designed stress study can provide insight in choosing the appropriate formulation for a proposed product prior to intensive formulation development studies. It can prevent re-development or re-validation of a stability indicating analytical method. This paper outlines the scientific aspects of forced degradation studies that should be...
Alexander Delli Paoli, Jr.
This discussion addresses the physical properties of air and water vapor mixtures. The components of the heating, ventilation, and air conditioning (HVAC) process that alter the moisture content of air to achieve desired levels in the facility or manufacturing process being served are described. Topics discussed can be thought of as the “wet side...
Eugenie Webster (Khlebnikova)
This paper discusses statistical tools that can be used to analyze process validation data. It covers descriptive statistics, control charts, process capability, and tolerance intervals. The requirement for statistical analysis is driven by the US Food and Drug Administration’s Guidance for Industry Process Validation: General Principles and...
Bernard McGarvey
,
Brian K. Nunnally
,
John McConnell
Process modeling makes use of fundamental laws of physics to analyze the behavior of real systems. Process modeling can help identify not only what has or will happen in a system but also why it has or will happen. This approach can be used for both special and common cause variation and in all phases of variability reduction efforts. Use of...
This article is intended for process validation practitioners and pertains to selecting acceptance sampling plans, including rejection quality level (RQL), in a product manufacturing setting. The authors assume readers have a basic understanding of acceptance sampling including single and double attribute sampling and variables sampling plans. The...
Scott Sutton, Ph.D.
The contamination control plan is central to good manufacturing practice (GMP) because it describes the procedures and policies designed to create products under controlled conditions. The contamination control plan covers all phases of a facility’s status and, therefore, plays a major part in the master validation plan. The author provides an...
John E. Lincoln
Regulatory guidance documents have detailed considerations for software validation associated with medical devices. These principles may be applied to process equipment, facilities, test equipment, quality management systems, and other applications. All requirements for software development, distribution, control, upgrades, and final retirements...
Rizwan Sharnez, Ph.D.
For multiproduct cleaning validation, acceptable carryover of the previously manufactured active pharmaceutical ingredient (API) (Product A) into the subsequently manufactured API (Product B) is determined through a maximum allowable carryover (MAC) calculation (1). A limitation of the conventional MAC approach is that if the previously...
Ed White
Container-closure integrity is a critical property of a pharmaceutical product. This attribute is especially important for sterile products. The US Food and Drug Administration guidance has categorized container-closure risks for common pharmaceutical products including degree of concern associated with route of administration (highest-low) and...

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