Ipca is an established Indian pharmaceutical company manufacturing over 350 formulations and 80 active pharmaceutical ingredients for various therapeutic segments. Headquartered in Mumbai, Ipca manufactures and sells branded and generic formulations, APIs and intermediates to 120+ countries. As one of the world’s largest drug manufacturers, they are inspected by US-FDA, UK-MHRA, EDQM- Europe, WHO-Geneva, PMDA and many other regional regulatory bodies.
Ipca had performed a rigorous assessment of their current drug safety process, regulatory requirements, system requirements (both current and future scale up) and observed that there were opportunities for improvements across processes, systems and their vendor engagements.
Following were some of the key challenges for Ipca:
- The two safety databases were not integrated, resulting in omissions, redundancies and leading to compliance challenges
- There were unmet needs such as advanced signal detection/ management and automation of case submission with agencies via gateway
- Inefficient management of global operations as each region was following a different workflow for case management. Case processing was challenging resulting in missed timelines and increased costs.
- Reporting, insights and signaling was challenging due to lack of right tools and due to separate databases
To fulfill Ipca’s business objectives of optimizing their drug safety operations, Techsol proposed a comprehensive solution with the accomplishment of the following activities:
- Implement AccelSafety with the Oracle Argus Safety Standard Edition along with Empirica Signal/Topics and Oracle B2B Gateway for Ipca on Techsol’ fully-managed cloud platform
- Assess and implement configuration best practices including harmonization of P&L (Products & Licenses), submission workflow process, dictionary management, reporting, etc.
- Complete risk-based validation as per Techsol computer systems validation process and produce audit-ready validation documentation for 21 CFR Part 11 compliance
Deliver a hands-on Argus Safety training for Ipca’s business users and application administrators - Complete legacy case data migration using Techsol’s proprietary multi-phase, migration methodology to ensure data quality and integrity
- Conduct pilot testing of electronic submission with regulatory agencies
- Set-up post-implementation Argus Safety service desk for hypercare and ongoing support
With the successful implementation of Techsol’s AccelSafety, Ipca achieved following business outcomes:
- Primary objective and goal of having a state-of- the-art, fully integrated data-safety, e- submission and signal detection system was achieved
- The impact on business was immediate and significant. Efficiency of more than 60% improvement in meeting submission timelines and approximately 50% reduction in case processing times were observed
- With the utilization of e-Submission Gateway, the ICSR process was automated to provide timely ICSR submissions to FDA and EMA consistent with regulatory standards
- Now, Ipca could detect signals, uncover patterns, and perform/recognize trends on case data.
- AccelSafety was ready as a scalable cloud platform to address Ipca’s future growth
- 24X7 Techsol managed service desk was established to address all post-go-live support activities