In February of 1993, one of the most influential court decisions to impact daily pharmaceutical operations was made. Our staff has made every effort to generate an outline of what is necessary to understand the outcome of this decision and the impact on quality systems.
As an added overview, we have included an overview of “Conducting an Investigation”. This section of the guideline will give the reader a summary of what is required to be in an investigation as outlined by the Barr Decision and GMP. A bonus for purchasing the booklet is a diskette containing the 47 page final decision.
This 17-page guideline was written to provide a training and compliance “tool” for your team. Our staff has made every effort to generate an outline of necessary to understand the Barr Decision. The contents are as follows:
· Background
· Court Rulings – An Overview
· Error Type Review
· Retesting
· Resampling
· Averaging
· Remixing
· Blend Testing
· Validation Criteria
· Investigation Overview
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