#FutureReadyHealthcare
De-merged entity ropes Indegene to check regulatory inspection readiness
The Customer
A global pharmaceutical company separated its Biosimilars business into a standalone entity. However, during the transition, there were significant challenges in ensuring stability, quality, and adherence to deadlines by new vendors and business partners. As a result, the client, which is the separated Biosimilars business, decided to conduct a second audit to assess their readiness for inspections.
The Need
Audit end to end functioning of select vendors and business partners for
QMS (Quality Management System)
Operational practices across PV functions under contractual agreement with vendor and partners (SDEA) including records management, data privacy and BCP
Staffing practices
Proprietary technology systems used
Carry out sample output review for quality and compliance
Detail the findings and suitable recommendations for gaps
The Solution
Indegene used its proprietary Audit Framework that encompasses process, people, and systems readiness and imbibes regulatory requirements (regulatory regions covered in this audit were US FDA, MHRA, and EMA). It conducted
In-person and remote audits across vendors and business partners, with each audit spanning ~3 work days and involving stakeholder interactions, documents review, and findings discussion
Statistical risk-based audit sampling for the outputs review
Indegene documented the findings by risk levels and discussed recommendations for each auditee with the client
Outcomes
20+
Broad categories of critical findings
<3 months
To complete RCA (Root Cause Analysis) and CAPA assessments (Corrective and Preventive Actions)
Let’s partner for #FutureReadyHealthcare
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