JVT Journal Articles
Vol. 17, Issue 2, Jun 2011

Physicochemical properties of active pharmaceutical ingredients (APIs) and excipients used in the manufacture of pharmaceutical dosage forms play a critical role in the successful design of robust and validated cleaning processes. The development and validation of these methods requires an understanding of the solubility properties and resistance to degradation of formulation components, including both API and excipients.
The following key points are discussed: Linear regression is a widely used statistical tool with numerous applications in the pharmaceutical and medical device industries. Fundamental concepts associated with linear regression are discussed. An example statistical analysis using simple linear regression of an active pharmaceutical ingredient...
The following key points are discussed: Good science requires stable process operations with low variation It is good management to reduce the variation in any quality characteristic, whether this characteristic be in a state of control or not, and even if few or no defectives are being produced Taguchi’s methods, Deming’s approach, Six Sigma...
Orlando Lopez
This article examines the management of requirements during the computer system lifecycle. Five categories of activities are identified. Specific actions within each category are described. Requirements management comprises a significant portion of system lifecycle costs and must be well controlled. A listing of applicable tools to facilitate...
The maximum acceptable carryover (MAC) criterion is widely used to set cleaning validation acceptance limits for multiproduct equipment. The conventional approach for setting cleaning validation limits based on the MAC criterion results in acceptance criteria that are much more stringent than necessary. This often results in cleaning validation...
The following key points are discussed: Oral modified release (MR) dosage forms are developed by altering the drug release to achieve predetermined clinical objectives. MR solid oral dosage forms include extended release (ER) and delayed release (DR). Matrix, reservoir, and osmotic pumps are the most common ER delivery systems.
Paul L. Pluta, Ph.D.
The following key points are discussed: The US Food and Drug Administration issued Process Validation: General Principles and Practices in January 2011, which has given widespread visibility to the lifecycle approach concept. The process validation guidance integrates strategy and approaches to provide a comprehensive approach to validation....
The following key points are discussed: A validation case study involving a validated manufacturing process is described. The process met all acceptance criteria, and it was judged to be validated. Products from the manufacturing process had a significant level of waste and rejects.
The following key points are discussed: Objective evidence defined Scientific analysis for objective evidence Protocol requirements to obtain objective evidence US Food and Drug Administration scientific, legal, and associated requirements for objective evidence.
John E. Lincoln
Future changes in the 510(k) process as suggested in the US Food and Drug Administration’s January 2011 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making. The 510(k) Working Group was charged with evaluating how well the 510(k) program was meeting public health goals and exploring actions the...

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