JVT Journal Articles
Vol. 16, Issue 4, Nov 2010

Risk communication is a key component of the quality risk management process for which problems of subjectivity and uncertainty may arise. This is a result of the fact that stakeholders form judgements about risks based on their own perceptions of those risks. Individual perceptions may lead to subjective differences in opinion and uncertainty about the outcomes of quality risk management exercises. It is important to...
Gregory P. Martin
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Vivian A. Gray
Dissolution data are critical to demonstrating the performance of a drug product. Instrument qualification to assure consistent performance and data integrity is challenging. A number of instrument parameters that may affect the reliability of dissolution testing have been identified. In an on-going effort to improve the effectiveness of...
The following key points are discussed: A solid dosage form is a complex mixture of multiple solid components. A systematic application of scientific principles to formulation and process design results in an increased level of product and process understanding. This approach enables higher levels of assuring assurance of product quality and...
Paul L. Pluta, Ph.D.
The following key points are discussed: A validation case study involving cleaning validation and the observation of unknown peaks in high-performance liquid chromatography (HPLC) chromatograms is discussed Unknown peaks were observed from testing of swab samples following cleaning of suspension products containing insoluble active drug,...
The following key points are discussed in this article: Validate for “intended use” utilizing criticality and complexity Use criticality and complexity to determine documentation deliverables for computer system validation Plan considering regulatory impact and validation deliverables utilizing criticality and complexity input.
Bernard McGarvey
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Brian K. Nunnally
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John McConnell
The following key points are discussed: There is a right way and a wrong way to control chart. Do not use aggregated data when constructing a control chart. Do not control chart a measure simply because it is easy. Control chart the measure because it gives insight into the process. Do make sure that the control chart limits are calculated...
David LeBlond
The following key points are addressed: On February 5, 2010, the US Food and Drug Administration Center for Devices and Radiological Health and Center for Biologics Evaluation and Research issued a final Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials. The guidance furthers FDA’s efforts to foster innovation,...
Scott Sutton, Ph.D.
The following key points are discussed in this article: The client organization is responsible for all data and analysis that contributes to the decision to release a batch of product to the marketplace accordng to good manufacturing practice (GMP). Contract lab reports must provide sufficient information to meet regulatory expectations....
Paul L. Pluta, Ph.D.
The following key points are discussed: Validation performance qualification is expected to be confirmatory (i.e., the validation is expected to confirm the design, development, and other support work associated with the respective validation). Personnel involved in validation may not know or understand current validation expectations....
John E. Lincoln
The following key points are discussed: This discussion addresses the third 510(k) option, the “traditional” 510(k) This 510(k) option is used when a proposed medical device submission does not clearly match the criteria of the other two less-involved formats—Special 510(k) Device Modification or Abbreviated 510(k) A suggested 510(k) general...