Self-inspection is now mandatory for Indian Pharma Manufacturers as part of a more robust Pharmaceutical Quality System (PQS) and Revised Schedule M Guidelines, to be complied by Dec 31, 2025.
A self-Audit is complete cGMP checklist to be audited by internal team and prepare a digital records of report with compliance score. The report serve as a primary document for new inspection which shows awareness and readiness of the manufacturing unit for approvals.
SASCOM GMPro is modern compliance software offering complete self-audit, self-inspection solution for manufacturers across world. The software comes with pre-loaded templates and checklist for cGMP, WHO GMP, PIC/s, US FDA, EMA and other regulatory agencies based on company’s requirements.
For demo, contact us at bdm@reevsense.com or call us on +91 97262 31931