The development of a drug product is a lengthy process involving drug discovery, laboratory testing, animal studies, clinical trials and regulatory registration. To further enhance the effectiveness and safety of the drug product after approval, many regulatory agencies such as the United States Food and Drug Administration (FDA) also require that the drug product be tested for its identity, strength, quality, purity and stability before it can be released for use. For this reason, pharmaceutical validation and process controls are important in spite of the problems that may been countered. IPQC are checks that are carried out before the manufacturing process is completed. The function of of in-process controls is monitoring and if necessary adaption of the manufacturing process in order to comply with the specifications. In-process materials should be tested for identity, strength, quality and purity as appropriate and approved or rejected by the quality control unit during the production process. Rejected in-process materials should be identified and controlled under a quarantine system designed to prevent their use in manufacturing.

IPQC Software supports for the functionality of the IPQC operations according to needs of the industries. IPQC software is web based application defined for the in-process sampling for IPQC instruments on real time basis. It contains instrument details, calibrations status, work flow definitions, 21 CFR, reports, integration to ERP/MES. IPQC software can be hosted in cloud and allows to access from remote locations. It is integrated with ShopFloorKonnect for reading data from multiple IPQC instruments.

Following are the key functions of the applications are:

Login Module
IPQC Instrument configurations
In-Process Quality Assurance Work Flow
Recipe Creation
Integration with ERP/MES for Recipe integration
Test ID creation based on Recipe
Test Process
Test Result
Test Compilation with BMR Limit
Integration with MES for Recipe and Test Results
Report module
21 CRF Part 11 requirements of the system for Security and Audit