INDUSTRY 4.0: How Pharmaceutical Quality Review Time Was Cut by 80%

Streamlined GXP Batch Report Using PI System Data & PI RtReports.

About the company

  • Objective: Streamline GXP Batch Reports
  • Industry: Pharmaceutical
  • Result: 80% Time Saving for Report Review
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The Background

Sluggish Batch Release

A top global pharmaceutical company was performing quality batch review of their product formulation batches using a standard, “off-the-shelf”, Batch Execution System (BES) report.

The Challenge

Lack of access to contextualized data

The BES report was excessive, containing all batch-related information, only a fraction of which was quality-critical.

The end result was a report up to 80 pages long.

As a result, quality reviewers had to sift through the reported data to find the valuable information. This also necessitated specific training to identify those report sections and Critical Process Parameter (CPP) data required for batch release decisions.

Report section content and layout was built to specifications of quality and operations.
All electronic reports and approvals were easily accessible online, with the option to render PDF copies for distribution.
The RtReport GMP batch report provided all relevant batch information in 5-10 pages — down from 80 pages.

The Solution

Streamlined GXP Batch Report Using PI System Data & PI RtReports

This was achieved without any changes to the underlying control system..

TQS developed a streamlined batch report using RtReports and PI System Data, focusing on the CPPs & CQAs identified by the client. The report only displayed alarms that were quality or process critical.

TQS then performed a data audit — to ensure all data for the new RtReport data was integrated to the OSI PI system and validated.

Aggregated data values such as min, max and average were calculated directly in RtReports.

TQS also developed advanced calculations using AF Analytics to calculate aggregated data over time periods not provided by the BES batch context.

"RT Reports has made everything easier — all the relevant information, streamlined, automated, and easily accessible in electronic reporting. Now, we can get straight to focusing on what’s important. It’s resulted in a much smoother and quicker batch release process for us.” — QA Manager"

As the RtReport contained logic for automatic checking of Batch Data excursions and quality-critical alarms, the same logic was applied in an exception report variation of the detailed RtReport.

This exception-based report provided detailed information for batch steps containing exceptions/excursions — and summary information with excursion/violation status for all other steps.

The Results

90% Time Saving for Report Review

By only focusing on relevant information, the review process became quicker and easier.

  • The RtReport GMP batch report provided all relevant batch information in 5-10 pages — down from 80 pages.
  • Report section content and layout was built to specifications of quality and operations.
  • Any excursions were automatically detected by the RtReport and highlighted to reviewers.
  • Data integrity was verified through 100% testing of RtReport data to adhere to ALCOA
  • Report review and signoff was done using a web client. Electronic signatures were used which were 21 CFR Part 11 and Eudralex Vol. 4, Annex 11 compliant.
  • All electronic reports and approvals were easily accessible online, with the option to render PDF copies for distribution.
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