Introduction To Validation
Where Did Validation Come From?
From disasters:
1971–7 deaths in USA
1972–5 deaths at Devenport Hospital,UK
Began in 1970’s
Originally sterilized based
Now evolved...
Temperature and Humidity Validation: Mapping in Storage Area
Pharmaceutical ingredients are placed or stored at various places for example raw material storage area, refrigerator, quarantine area, large cold rooms, packaging room, freezer,...
Guidelines for Preparation of Validation Master Plan (VMP)
Validation Master Plan
VMP is a roadmap of validation activity like facility qualification and also define system and area to be validated. VMP justifies the...
Disinfectant Validation
The objective of this validation protocol is to demonstrate the efficacy of a disinfectant solution which are being used for the surface and area...
Basics of Cleaning Validation
Cleaning validation is primarily applicable to the cleaning of process manufacturing equipment in the pharmaceutical industry. The focus of cleaning validation is those cleaned surfaces...