Stopping the problems that stop the process.
Batch testing is an ongoing process for most companies and Quantum Analytics Group receives a substantial amount of work from pharmaceutical manufacturers who run into problems that arise before, during and sometimes even after production.
The Problem
This well-known prescription tablet was stuck in the testing cycle after some small process changes were initiated.
The Assignment
An external consultant, working with the manufacturer, suggested the need for additional investigative work.
The Challenge
The tablets were inconsistent. Not in color or size, but in how they went into solution for the testing itself, causing variability in analytical results.
The Issues
This instance had never been seen before within the company… the client’s QA team began focusing on the coating and excipient as possible culprits. And even suggested the method might be flawed.
The Timing
With such random variation, the Quantum team was looking at an assay schedule of at least 100 tablets a day. Ultimately, within our 30-day time limit we assayed over 2500 tablets.
The Solution
The real culprit was hiding in plain sight. By careful review of the recent process changes, Quantum was able to discover that one of the actual tablet presses was malfunctioning.
The Insight
Our earlier observations proved that the problem was not in the coating…and our review of the method showed no error. Essentially, we had to look in front of the method.
The Result
The press was recalibrated along with other upstream processes.
The tablet variation disappeared and production went back on line.
The Value
This small discovery saved days, and possibly weeks of re-testing.
The value of an experienced and consultative CRO can be dramatic – especially when things don’t go as planned! One simple inconsistency during the testing cycle can stop the entire production. Is your lab up to the challenge?