• CaliberBRM

BRM Case Study – Online Execution of BMR

A prominent global company, our client, aims to manufacture affordable products that improve lives across the globe. Providing medicines of the highest quality to their customers, is very much part of their mission. They endeavor to please every client and stakeholder through their focus, hard work and honesty. Their vision is to become one of the leading global generic manufacturers of quality pharmaceutical products by excelling in the fields of research, regulatory and manufacturing. However, they were facing problems in batch records preparation and control over issuance.

Challenges:

1. Planning for the dispensing of the materials and dispensing the same.

2. Calculation and adjustments of the actual quantity factor of materials w.r.t the API & Excipients in the BOM.

3. Management of the used containers in the production activity.

4. Implementing ground level workflow in execution of the Batches.

5. All the Master records were prepared in word file which was uncontrolled.

6. Control version of the Batch records was difficult to maintain through the word documents.

7. Batch Issuance and its tracking was not done sufficiently.

8. Retrieval and filing the dossier of the batch record was time taking process for the associates.

9. Issuance and tracking of extra pages through manual process was time consuming and hectic.

10. Excel Sheets were maintained to maintain the print log.

11. Storage of the batch records and persevering them until set time period was cumbersome activity.

Solution

CaliberBRM was implemented as a solution after extensive study and almost all activities related to BMR execution were automated.

BRM structure

1. Implemented at multiple facilities.

Critical processes were automated:

1. Dossier preparation team was dissolved as all the dossiers were generated in CaliberBRM.

2. Business decisions were made easy through various set of reports available through Batch Record Management.

3. Dispensing of the materials against the BOM quantities and within the tolerance limits

4. The AQF calculation was done in the system.

5. Container management and label management was made easier.

6. Ranges to the entries in the batch record were successfully assigned with the workflow.

7. Control over execution of the batch in sequence and as per desired workflow was attained.

Benefits

1. Fast tracking of master preparation, maintenance of log reports of issuance and various reports.

2. Version control of masters and issuance has become convenient.

3. Dossier preparation is made possible.

4. The AQF formula is configured as desired.

5. The label management helps labeling of multiple labels at different stages.