About Shahid Ali Expertise I can answer about all validation and qualification activities like Equipment qualification, analytical method validation, process validation, calibration and verification, Machine capability study, stability studies, cGMP, GVP, GDP, QMS, TQM, ISO and Regulatory affairs.
Expert: Shahid Ali Date: 7/8/2008 Subject: about IPQA role
Question sir,
kindly give me to provide information about IPQA officer in pharmaceutical companies. what's the role of IPQA ?
Answer In process Quality Assurance officer has a very great role in maintaining cGMP compliance not only for routine mfg inprocess, but also for the over all Plant activities. IPQC monitoring starts right from raw material issue to the finished product release. IPQC officer must be vigilant and sharp enough to check and verify the system compliance. He/she should have a hawk eye, to identfy the non conformances. An IPQC officer is majorly involved in Inprocess inspection of dispensing, mfg, and fsg beside these he/she also involved in performing some special tasks like capability studies, machine qualification, Process validation, cleaning validation sampling. IPQC has a great role in maintaining documentation and inspection of Batch mfg records, data archiving, praparing Trend analysis reports, corrective and preventive action record. IPQC is considered to be the backbone for Quality management system, to implement the over all system as per SOPs, quality system procedures, work instructions and Quality objectives
