A "deviation" in manufacturing is when manufacturing steps are changed in some way from the set guidelines. Production guidelines are very detailed based on supply contract specifications, product ...

Learn about methods of investigating the root and probable cause of deviations that occur in pharmaceutical and biopharmaceutical manufacturing, and hear case studies of actual investigations.

Standards are established for a reason in business — repeatable processes yield repeatable results. But that doesn’t mean some flexibility shouldn’t be allowed under certain circumstances. The key is ...

The pharmaceutical industry is making efforts by internally assessing, developing, and implementing semi-continuous manufacturing processes to improve manufacturing efficiencies. The continuous ...

The following data set (WIRE) contains breaking strength measurements recorded in pounds per inch for 25 samples from a metal wire manufacturing process. The subgroup sample sizes vary between 3 and 7 ...