Case Study
Achieving Compliance Excellence: UST transformed ISA88 batch processing at global pharmaceutical maker
After an internal audit found ISA88 batch processing issues in several of its manufacturing facilities, the company needed to quickly uncover and address the root-cause issues. UST helped the pharmaceutical giant resolve the compliance issues in just 90 days and roll-out a new batch record best practice strategy in all production facilities in 18 months.
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CLIENT
This European-based pharmaceutical company delivers life-changing treatments to improve the outcomes of patients battling cancer, chronic conditions, and rare diseases. As a global organization, it operates dozens of facilities in countries around the world and generates nearly $50 billion in annual revenue.
CHALLENGE
Creating a batch record remediation program to reduce business risks
After performing an internal audit, the company found inconsistencies in its ISA88 batch record standards in 12 production facilities. Further analysis pointed to multiple issues in the standards and adherence to governance policies. This lack of consistent batch records put the company at serious operational and compliance risks. The client needed to enhance its batch record standards and bring the existing records up to the new standard as quickly as possible.
TRANSFORMATION
Ensuring ISA88 compliance in pharmaceutical batch processing
UST devised a multi-pronged approach to help the pharmaceutical company harmonize its global ISA88 standards. After a root cause analysis for batch record inconsistencies, we understood how the issues developed in the first place and the associated risk severity. From there, the team identified compliance issues that needed immediate attention and lower-priority non-compliance opportunities to enhance manufacturing efficiencies. UST also developed an ISA88 batch record best practice strategy that balanced near-term operational needs with the overarching goals of enhancing production efficiencies and optimizing the manufacturing process while ensuring ISA88 batch processing compliance.
In less than 90 days, the company addressed all compliance issues, and in 18 months, the new ISA88 batch record management system was rolled out in all manufacturing facilities across the company.
IMPACT
Maintaining its position as a pharmaceutical industry leader
Now, the company can rest assured that its manufacturing processes adhere to the rigorous ISA88 batch processing standards, reducing operational and compliance risks. The regulatory standards also contribute to greater production efficiencies across the company’s global manufacturing facilities to ensure:
- Consistent product quality—so every pharmaceutical product is identical and properly formulated
- Excellent safety and effectiveness—so providers and patients can trust that medications will work as expected without causing harm
- Production traceability—to quickly identify supply chain issues
- Optimal equipment and machinery utilization—to maximize production throughput without compromising safety or quality
RESOURCES
https://www.ust.com/en/what-we-do/strategy-implementation-operations
https://www.ust.com/en/what-we-do/digital-transformation
https://www.ust.com/en/industries/healthcare-and-life-sciences