• CaliberBRM

BRM Case Study – Offline execution of BMR

A leading global pharmaceutical company, our client, with impressive annual turnover and production in contract manufacturing products with four plants and multiple departments, was facing the problem with the batch records preparation and control over-issuance.

Challenges:

1. All the BMR/BPR were prepared in word document which led to uncontrolled practices.

2. The control version of the batch records was difficult to maintain through the word documents.

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

4. Retrieval and filing the dossier of the batch record was time-consuming process for the associates.

5. Issuance and tracking of extra pages through the manual process was time taking and hectic.

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

7. Storage of the batch records and preserving them until the set time was a cumbersome process.

Solution

Caliber eBRM was implemented after a thorough requirement study of all the GMP document management was made, and the configurable engine for the preparation of the batch records was executed.

BRM structure

1. Implemented at 3 Facility then rolled out to 4th.

Critical processes were automated:

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

2. BRM review and approvals process was automated.

3. Business decisions were made easy through various sets of reports available through Batch Record Management.

4. The process of batch records superseding workflow became easy comparatively.

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 made possible.

4. The time taken for preparing the new BRT came down exponentially, and the team could prepare the new batch records with ease.

5. The process of batch record review and approval is accelerated with the availability of all the necessary audit trails required by the reviewer and approver.

6. The audit trails provided carried complete information for audit purposes.