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 Reading Quality Metrics – New FDA Guideline

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 Reading Media Fill Test – Aseptic Process Simulation in Micro

Local Area Network (LAN) Qualification Guideline

Standard Operating Procedure (SOP) for Local Area Network (IT Network / LAN) qualification procedure, Protocol, and related documentation. Procedure for qualification of IT network equipment’s for the fulfillment of availability…

Continue Reading Local Area Network (LAN) Qualification Guideline