Mr.John Fetzer

If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP. All methods must be validated, the proof t ...

Any laboratory that supports products for sale or use in the United States must follow Good Laboratory Practices (GLP), a comprehensive system that guarantees the validity of results. If you work in pharmaceuticals, chemicals, petrochemicals, and environmental ...

Instrumental gas chromatography as an analysis is widely used to determine purity, the impurities, and the degradation products of pharmaceuticals. The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation ...

Statistics can be used to monitor critical variable in the running of a procedure and in the performance of the instrumentation that performs it. By applying Nelson’s rules this data can be evaluated as performing as expected or performing in ways that are sta ...

Background : Control charts are based on the distribution of data expected in a laboratory, the Gaussian distribution of occurrences. There are well defined probabilities for the data. Guidelines for good or unacceptable behaviour are well known. The most common of t ...