Our client is one of the leading multinational pharmaceutical company offering therapeutic solutions in cardiovascular diseases, thrombosis, diabetes, internal medicine, central nervous system, oncology, arthritis and osteoporosis, primary health care, vaccines and consumer healthcare. The company was facing issues in stability process.
In the Quality Control Laboratory, the following were the challenges faced by the analysts, group leaders, Section in charge, reviewers, managers and HOD.
1. Manual Stability Schedule was prepared, and samples were also generated manually.
2. Stability Summary Reports were prepared manually, reviewed and approved.
3. Worksheets were prepared manually, reviewed, approved and issued by QA.
4. Certificate of Analysis (COA) was prepared manually, reviewed and approved.
5. Labels were prepared, reviewed and approved manually.
A. Our client implemented Caliber Stability for Quality Control and Analytical Development at GIDC (Goa).
B. Semi-Automated LIMS installed with the following features:
1. Creation of Product Specifications – Sample Manager (MASTERS)
2. Sample Workflow with Investigation Cycle
3. Stability Management
4. Label Management
1. In Stability Management Module, we have provision to create the stability protocol by defining no. of stations, chamber conditions and test(s) selection for each pull. As per sample pull date, system was auto generating the samples by maintaining reconciliation.
2. In Stability Management Module, we have provision for printing stability summary reports. The data from the approved COA’s is directly fetched by the system and compiled into stability summary reports.
3. There is a provision for creating and printing of worksheets and attaching to the test plan as per the need. The test plan can be created and signed electronically and is available in the system at any point of time. The worksheets are printed using print control.
4. We have provision for printing of Certificate of Analysis in the system wherein the data entered by the user is compiled by the system in the form of Certificate of Analysis (COA). The COA’s are printed using print control.
5. In Label management module, we have provision to create label templates. The data is directly fetched from the A.R. No. entered in the system, and labels are printed with barcode using print controls.
How Did CaliberLIMS Help Achieve Success during Audits
1. We explained and illustrated the QC flow process followed in CaliberLIMS to auditors.
2. With use of CaliberLIMS, we could eliminate missing of stability pulls.
3. The data transcription error is eliminated during preparation of COA’s, stability summary reports and labels.
4. Worksheets could be printed any time by the analyst himself rather than relying on QA for worksheet printout.
5. Data integrity is enhanced by using caliber LIMS as all the activities performed in the system are tracked and date and time are stamped.
6. Printing of Worksheets, Labels and COA’s are controlled by print count (control)in the system.