Stability Studies in Oracle R12

Linda Reader Quality Control Manager – Lofthouse of FleetwoodNeal Lynch Project and Change Manager – Percipient

Who are Lofthouse of Fleetwood?

• 1865 In the beginning…

Fleetwood pharmacist James Lofthouse develops a menthol and eucalyptus liquid for fishermen in Fleetwood to take with them on stormy and freezing trips into the North Atlantic. It delivers instant relief from problems caused by the prolonged exposure to hostile conditions.

Due to the difficulty of taking the liquid in glass bottles onto choppy high seas, James makes a lozenge from the liquid that the fishermen can take instead. Sales are pretty much stable for a century until...

• 1967 By popular demand

In response to letters from holidaymakers who have visited Blackpool and Fleetwood, the Lofthouse family recognised the huge potential of Fisherman’s Friend, and start selling to shops in surrounding towns in the North West from their van.

Who are Lofthouse of Fleetwood?

• 1972 On the move

As demand increases, packaging of Fisherman’s Friend is moved to a newly converted tram house in Fleetwood. The new packaging in black and red reflects the historic typewritten labels of the brand (so produced due to having both colours on the typewriter, and not wanting to waste the red ribbon).

• 1983 A royal seal of approval

Fisherman’s Friend is awarded The Queen’s Award for Exports. Over the next few years, they go on to win another two Awards, making Fisherman’s Friend the only UK confectionery company to win three times!

• 2014 On the rise

Fisherman’s Friend remains a family business, producing over 5 billion lozenges a year. Its export-focused strategy sees the brand expanding rapidly in South East Asian markets.

Oracle Modules we use

� Version 12.1.3

� Now into our 2nd year using Oracle Manufacturing� Products used –

� OPM � Discrete WIP (EAM)� Quality for OPM� Supply Chain BI� ASCP

Why do we need to use Stability

Studies?

• Fisherman’s Friends lozenges are registered as medicines in some markets and Stability Study data is submitted as part of Regulatory Submission

• It is a GMP requirement that Stability Studies are conducted

• Shelf-life data required to establish BBE dates for confectionery

• Stability Studies conducted to:

• Establish a suitable expiry date / shelf-life

• Determine suitable storage conditions

• Ensure product meets specification throughout shelf-life

What did Percipient build and how we

use it• Setup – Test Interval Plans

• Setup – Storage Condition Plans

• Item Samples

• Spec Association

• Create Stability Study

• Approval

• Start the Study

• View Samples

Legacy Integration

• Prior to the implementation of Oracle the business used LIMS to record and report on Stability Studies.

• One of the requirements of our implementation was to close down all legacy systems.

• Percipient built a solution to take the legacy extract from LIMS and add this data to the updates that were recorded in EBS.

• Stability Study Results Report

• Pull Report