As an example of how to prepare a report of a Plant Accident, we show the Report of the Accident on 25 July 2000 at…
Category: QualityManagement
This article presents a detailed summary of the drug GMP warning letters issued in FY2018, as well as a comparison of trends since fiscal year…
The temptation to revert to old habits will be tested, but must be avoided. Laboratory environments are one of the next frontiers for the application…
Three different quality indicators to be used as standard self-assessment tools have been developed in a collaborative project between FDA and ISPE International. The Food…
Below a selection of KPIs is listed for every benchmarked lab . All KPIs that are marked with * are provided as overall KPIs as…
The pharmaceutical industry is in many ways unique. The challenges facing pharmaceutical companies, including large pharma, biotech and generics manufacturers are sometimes overwhelming. Diverse laboratories,…
Technical supplement to WHO Technical Report Series, No. 961, 2011 Annex 9: Model guidance for the storage and transport of time and temperature–sensitive Pharmaceutical products What is…
Technical supplement to WHO Technical Report Series, No. 961, 2011 Annex 9: Model guidance for the storage and transport of time and temperature–sensitive pharmaceutical products This technical supplement…
This technical supplement has been written to amplify the recommendations given in section 4.7 of WHO Technical Report Series No. 961, 2011, Annex 9: Model guidance for…
Temperature mapping establishes the temperature distribution within the zone being mapped and it locates hot and cold spots. A temperature mapping exercise is required for any space…