Review a batch record and investigate a hardness deviation

You are the Production Supervisor in the compression suite at Western Sydney.

Simulated workplaceAdvanced missionCAQA Orchard Lane Foods

What is going on

Batch WS-26-0412, paracetamol 500 milligram tablets for a contract customer, was stopped at hour three of compression when an in process tablet hardness result fell outside the limit in the batch manufacturing record. The batch is on hold, a deviation has been raised and engineering is checking the compression force sensor on tablet press 1. The batch record contains the dispensing, granulation, drying, blending and compression steps with second person verification. Rohan Mehta needs the production review completed, every finding listed, the deviation assessed and an investigation drafted with the data needed to decide whether the batch can be released, reworked or rejected. The customer expects a position by Friday.

Rohan Mehta, Pharmaceutical Site Manager
Subject: Batch WS-26-0412 record review and hardness deviation

Batch WS-26-0412 has been on hold since 3 September after a tablet hardness result outside the in process limit at hour three. Engineering is checking the compression force sensor. I want you to complete the production review of the full batch manufacturing record, list every finding, assess the deviation against the batch release procedure and the good manufacturing practice policy, and draft the deviation investigation with root cause options and the data needed to decide the disposition. The customer expects a position by Friday.

Your brief

Complete the production review of the batch manufacturing record against the good manufacturing practice policy and the batch release procedure, assess the hardness deviation, draft the deviation investigation with root cause options and data requirements, and record everything in the register so quality can decide the disposition.

Work through it

You do not need to do it all. Doing a few of these will show you what the work is like. Your ticks and notes stay on this device.

Read the Good Manufacturing Practice Policy and the Batch Record Review and Release Procedure and list the production review checks in order.
Review the batch manufacturing record step by step for completeness, contemporaneous entries, second person verification and correct corrections, and list every finding.
Compare the in process results for hardness, weight and thickness across the run and identify when the trend began to move.
Review the granulation and drying records for moisture results and the dispensing record for lubricant quantity, and note any link to the hardness result.
Draft the deviation investigation with the possible root causes, the data needed from engineering on the compression force sensor, and the tests quality will need to decide disposition.
Update the register entry for the deviation with your findings and the status, and update the batch record notes in the batch record system.
Prepare a briefing for Rohan Mehta and the customer with the facts established, the open questions and the timeline to a disposition decision.

My notes: what did I enjoy, and what surprised me?

What someone in this role would produce

Production review findings list
Draft deviation investigation
Updated register and batch record entries
Briefing for the site manager and customer

Printing this is a record of what you explored. It is not a certificate or a qualification.