GMP-compliant documentation is an important element! The GMP requirements for documentation can be found in Chapter 4 of the EU GMP-Guideline. The documentation consists of standard and recording documents and can be paper-based or electronic. What r...
Deviations must be investigated! , Deviations must be reported and investigated. An assessment is to be made as to whether the deviation has an influence on the product quality. Corrective and preventive measures must be defined and implemented....
compactGMP compactGMP is a PTS eLearning module that provides an overview of important GMP rules, especially for newcomers or employees of external companies. GMP employees at the operational level benefit from this module by repeating important GMP...