Improved acceptance rate and real-time QC in pharma manufacturing

About client

The client is a leading pharma company. They have production plants for vaccine manufacturing in multiple global locations. They have highly compliant production spaces, modern labs, and well-planned production cycles to maintain product and batch consistency and stay in line with compliance requirements.

Challenges

Being a medicine producer manufacturing various drug products, the client must adhere to many regulatory challenges to ensure product safety and effectiveness. Some of the challenges their quality control (QC) team encountered are as follows.

Low lot acceptance rates: Their current lot acceptance rates for drug products and drug substances were 45% and 46%, which is much less than industrial standards. Also, the OOS invalid rates were 52% and 58% for drug products and drug substances, affecting production timelines.

Delayed CAPA closures: Poor tracking CAPA resolutions and its task status led to delayed closures. Their current CAPA closure rate for drug products and drug substances were 63% and 65%, which meant that most of their CAPA verification tasks were pending.

Audit issues: Their company had frequent internal audits, as they identified critical, major, and minor issues during their findings. But poor tracking of audit records led to low to no follow-ups on closure of these findings.

datakulture solution

Our data analytics team came up with the solution – quality performance analytics to share key quality metrics in real-time with relevant stakeholders.

The impact our solution created

Acceptance rate improvement: LAR (Lot acceptance rate) analysis and QC dashboard helped the client track lot acceptance rates for drug products and substances in one place. The client could make improvements in acceptance rates in real-time as they could observe the comparison of current values against the set targets through trend lines.

Their acceptance rate improved 12% for drug substances and 15% for drug products, once they start visualizing these key QC metrics.

Tracking products and departments wise: They could also track OOS, which lets them monitor end-to-end production and environmental compliance across departments like BCG-QC, Microbiology, and others.

Fast CAPA closures: Tracking was also set up for corrective and preventive actions, which led to more streamlined CAPA addressing and closure. They could finish their CAPA backlogs and noticed a 22% improvement in their closing rates.

Audit analysis: Audit findings and reports are segmented based on severity (critical, major, and minor), status (planning, execution, and closed), and period for in-depth tracking, which helped them see what’s pending and the time left to finish them. With this new presentation, they could close 10% more audit findings on time and ensure that critical issues are addressed before it's too late.

Conclusion

Quality control, the crucial function of our client’s manufacturing unit, is now under control, thanks to reliable, on-time, and straightforward insights delivery through reports, alerts, and interactive dashboards. Their audit compliance is more organized, they could align their departments better, and they could track every stage of OOS, make constant improvements, and ensure safe and effective products leaving their unit.