Saturday, November 18, 2017

Factor Affecting Transportation of Pharma dosages – validation points

Transportation validation shall be carried out for Finished Goods being transported to the destination(s) of distribution from the manufacturing unit. During transportation, there is number of...

Preventive Maintenance Program

Based on the qualification studies, a program for preventive maintenance of all major manufacturing equipments and critical support systems should be developed and implemented to...

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...

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,...

Cleanrooms Facility Qualification – An Overview

Cleanroom qualifications performed as a result of new facility construction will be part of an overall project plan and associated validation master plan for...

Formula for Calculating Number of Air Changes in an Area (ACPH)

Number of air changes/hour in an area is = Total Room Airflow In CFM x 60 Total Volume of room in cubic feet For calculating Total Room Airflow...