This booklet includes below chapter is taken from PDA's bestselling Pharmaceutical
Quality, and offers an examination of quality from the perspectives
of senior experts working in industry, government and academia from around the
Using Statistics to Measure and Improve Quality
This booklet is an introduction to the application of applied statistics to quality assurance, quality control and manufacturing under the Current Good Manufacturing Practice regulations (CGMPs) for the pharmaceutical, biopharmaceutical and related industries. Specifically, the focus is on those statistics that are most useful in working within the context of 21CFR 210 and 211 (FDA, 2001).
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Format: PDF (1 file - 1.05 MB)
Paper version is not available.
Table of Contents:
Statistics in Context with
The Role of Quality Assurance and
The Role of Manufacturing and Statistics
Fads in Quality
Out of Specifications
Finished Product Inspection
Annual Review Program and Trending