Statistical quality and process controls (SQC and SPC) are used for monitoring, trending,
and ultimately improving biopharmaceutical manufacturing processes and operations. The …

Pharmaceutical drug substances and drug products are manufactured following a well-
defined process in units of batches. Drug product batches consist of a large number of …

Many congratulations are in order to the seven authors of this excellent book, who are all
distinguished and experienced statisticians supporting CMC studies in the pharmaceutical …

BECAUSE I work in a regulated industry, I was intrigued by this book's title. A regulated
environment presents its own unique challenges when applying statistical methods and I …

Statistical process control is the application of statistical methods to the measurement and
analysis of variation process. Various regulatory authorities such as Validation Guidance for …

There are many different approaches for assessing process parameter criticality, and
assessing which process parameters have a significant impact on critical quality attributes …

Statistical process control (SPC) provides a statistical approach for evaluating processes
and for improving the quality of these processes through elimination of special causes …

The impact of the appropriate and inappropriately applied statistical metrics to verify the
State of Control of pharmaceutical manufacturing has been reviewed from an auditor's …

Recently, the FDA issued new quality guidelines (Q10) encouraging drug manufacturers to
improve their quality monitoring procedures. This renewed focus on quality and risk …

If every batch coming off a production line could flawlessly reproduce the original design,
there would be little need for statistical input in quality control. Unfortunately, in the real …