Pharmaceutical Development and Technology

Biography

Biography: Brijesh Gupta

Abstract

Environmental monitoring programme is a critical aspect of documenting the state of control of the manufacturing facility. The environment monitoring programme is considered as an important laboratory control that provides meaningful information on the quality of aseptic processing environment. Many laboratories still use paper-based systems to schedule the sampling process and manage the collection of this environmental data. However, with such a large volume of samples to be taken, organizing, retrieving and interpreting this information can be a challenge. Paper records and worksheets must often be manually logged into spread sheets for data to be shared or analysed. Purpose-built MODA^TM solution can overcome many of the limitations associated with paper-based approaches. MODA^TM can reduce errors by guiding users through data-collection protocols, preventing process deviations and prompting users to complete missing information prior to submission in ways that paper-based approaches cannot enforce. MODA^TM solution can ensure laboratories comply with regulatory guidelines by recording all necessary measurements according to standard operating procedures contemporaneously with help of Field Data Capture (FDC) units. Visualization Mapping Tool enables a correlation of test results with floor plans of the facility. The MODA™ solution can seamlessly integrates with Laboratory Information Management Systems (LIMS) to bridge the communication gap between QC and production. Other QC systems such as particle counters, identification systems and CAPA can be interface with MODA^TM solution. By combining automated scheduling, workflows, mobile data acquisition, device integration, and advanced analytics, the MODA™ Solution delivers efficiencies across the organization.