Client Overview
An India-based multinational pharmaceutical company approached Freyr for an Integrated Management System (IMS) service. The client sought Freyr's assistance because they did not have the internal expertise required to establish a management system.
Background
Following organizational expansion and integration requirements, the client needed support in developing a structured management system capable of aligning governance processes, regulatory requirements, and operational workflows.
The objective was to streamline audit processes and maximize efficiency by proposing on-site audits for multiple products across various sites and geographic locations, utilizing a single auditor from Freyr's global auditor pool.
Services in Scope
Integrated Management System (IMS) establishment
SOP development and rationalization
Governance SOP alignment
Regulatory SOP validation
Audit support and reporting
Documentation development
Risk assessment and management
Process review and updates
Challenge
Lack of Internal Expertise The client lacked in-house expertise to establish a management system.
Complex Product Portfolio The organization managed products across different target markets with varying Regulatory requirements.
SOP Rationalization Existing SOPs required rationalization and alignment.
Process Stabilization Processes needed validation and stabilization to support compliance and operational consistency.
Solution
1
Compliance Resource Deployment
Freyr proposed a team of four compliance resources and worked closely with the customer's quality analysis team.
2
SOP Classification and Alignment
The SOPs were classified into organization-level (Governance) SOPs and department-level (Regulatory) SOPs. Governance SOPs were rationalized to align with the parent company and ensure consistency, compliance, and efficiency.
3
SOP Validation and Documentation Development
Regulatory SOPs were validated to establish a stabilized process and minimize the risk of non-compliance. Initial draft SOPs and final SOPs were prepared and submitted as part of the Integrated Management System service.
4
IMS Implementation and Review
A thorough analysis of management system requirements was conducted. Audit findings were documented, risk assessments were performed, documentation was developed, and the IMS was reviewed and updated to ensure effectiveness and relevance to organizational needs.
Impact
Freyr supported the establishment of an Integrated Management System that enabled structured governance, process stabilization, and audit readiness.
Compliance Readiness
- Baseline SOPs capable of withstanding Regulatory audits were prepared.
- Audit-ready processes were established.
Operational Efficiency
- Streamlined audit processes were achieved.
- Enhanced efficiency was supported through on-site audits across multiple products, sites, and geographic locations utilizing a single auditor from Freyr's global pool.
Process Standardization
- Governance and Regulatory SOPs were aligned and validated.
- Integrated processes were established to support organizational consistency and compliance.
