Quality Metrics – New FDA Guideline

The term “Quality Metrics” means all those indicators that give an idea of ​​the collective quality characteristics of a certain production site. The number of rejected batches per year compared…

Continue ReadingQuality Metrics – New FDA Guideline

Grounding Requirement for Equipment and Building

Guideline (SOP) for grounding static equipment and building, but it is not applicable to transportation equipment, except when equipment is used in the loading or unloading of flammable material. The…

Continue ReadingGrounding Requirement for Equipment and Building

Media Fill Test – Aseptic Process Simulation in Micro

Guideline (SOP) to provide guidance for activities and analyses performed by Microbiology and Environmental Monitoring personnel in support of Aseptic Process Simulations (APS), also referred to as Media Fill Test.…

Continue ReadingMedia Fill Test – Aseptic Process Simulation in Micro