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Pharmaceutical Outsource Solutions is making available a forum where individuals may present position papers supporting practices that they consider to be industry "Best Practices". These views may propound activities that are not commonly performed, mandated by a regulatory agency, or even industry standard, but are considered by the author to be an activity important for consideration by the pharmaceutical and biotechnology community.
Note: The full articles listed below require Adobe Acrobat Reader to be viewed.
January 2011: "How to Resolve Controversial QA Findings", Scharberg, D.
Description: It can be hard to get resolution on controversial QA findings. It is important to understand where responsibility lies within the organization and what rational steps can be taken to get resolution. [View the abstract / full article]
January 2010: "Update Bioanalytical Methods Prior to Submitting Studies to the FDA", Scharberg, D.
Description: A warning that the FDA expects all bioanalytical methods to be current at the time of submission, even if the requirements have changed since the work was originally performed. [View the abstract / full article]
January 2008: "Four Lessons from MDS Montreal", Scharberg, D.
Description: Lessons that all sponsors should learn about taking responsibility for the bioanalytical data generated in support of their clinical programs. [View the abstract / full article]
April 2007: "Critical Recommendations from the Third AAPS/FDA Bioanalytical Workshop", Scharberg, D
Advice is given on the implementation of several critical recommendations from the Third AAPS/FDA Bioanalytical Workshop. [View the abstract / full article]
April 2006: "Ten Questions to Ask Your Prospective Contract Laboratory", Scharberg, D.
Description: Initiating work at a new contract laboratory can be difficult. Here are ten questions that should be asked to determine if a prospective laboratory really is the best organization to support your activities. [View the abstract / full article]
June 2004: "Quality Control Samples", Scharberg, D.
Description: Quality Control samples are vital for the validation and batch-level quality control of bioanalytical methods. However, they must be made and used in an appropriate function to perform their function. [View the abstract / full article]
February 2004: "How Product Failures are Related to Raw Materials", Scharberg, D.
Description: Many product failures are related directly to the false assumptions and poor practices used in acquiring and approving raw materials. [View the abstract / full article]
October 2003: "A Rational Approach to Qualifying a Contract GMP Testing Laboratory", Scharberg, D.
Description: Sponsors should submit "test samples" to contract GMP testing laboratories to be used as the basis for performing compliance and technical assessments as part of a qualification process. [View the abstract / full article]
May 2003: "The Use of Internal Standard Calibration with LC/MS/MS Bioanalytical Methods", Holstege, Ph.D., D.
Description: Internal standards used for LC/MS/MS bioanalytical methods should be isotopically labeled forms of the analyte to ensure method performance and minimize sample reanalysis. [View the abstract / full article]