Indegene Ensures Regulatory Inspection and Audit Readiness for De-merged Entity with Statistical Risk-based Audit Sampling

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)

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