Software Solution for Quality Control (QC) Micro Environmental Monitoring Data

Description

In setting up the vaccine manufacturing and innovation centre facility, VMIC will require a software solution for quality control (QC) micro environmental monitoring data. The background for the required management of environmental data is laid out below. The manufacture of the pharmaceutical vaccines must be performed under regulated, controlled conditions. These constant controlled conditions are essential to guarantee a consistent quality of manufactured products. This also applies to the staff working in these clean rooms. Regulatory directives therefore require monitoring of the environmental conditions including viable and non-viable particles and monitoring of the personnel during manufacturing processes. VMIC facility is designed to include cleanrooms and isolators with Grade A to D classification. Process gasses used in the manufacture process will have to be monitored for potential microbial contamination. Furthermore, Water for Injection (WFI) is manufactured within the VMIC facility that must adhere to regulatory standards and requires regular monitoring. VMIC QC Microbiology will be responsible for the performing of the monitoring of the above stated areas for the qualification of the facility and the WFI plant and will continue to monitor to enable operations in the clean rooms and manufacture of vaccines. To that end, a software solution is sought to enable the organisation and planning of the required monitoring activities; the collation and evaluation of data; transfer of monitoring data collated by external equipment directly into the software system; transfer of selected data to a Laboratory Information Management System (LIMS) for batch release purposes; and the trending of the environmental conditions. This software solution should enable improved data transfer from planning stage through to evaluation stage by providing considerable paperless solutions with guaranteed data integrity. The contract is for an implementation period followed by 3 years with an option to extend for a further 2 x 12 month periods.