When you can’t show me the data! When your process is not fully controlled! Will these new implementations fully comply with new world data integrity requirements? Imagine this scenario taking place in your board room 2-5 years ago. The CEO walks into the quarterly strategy meeting with and asks “What is the status of our companies move to a Digital4.0MES system? Because I hear our competitors are way ahead of us.” VP of Computerised Systems assertively answers we are in discussions with vendors and should have a 5 year strategy for roll-out in place in in 12 months time. I will provide an update at the next strategy meeting. What are the likely cost savings? Asks the VP of finance. In between the lines you have to ask what are the motives for the move to Digital4.0MES systems? In my criticality focused and patient centered world the motives would be to have processes in place to allow fully controlled management of the factory to ensure a right 1^st time all the time production of material of the highest quality knowing that all critical parameters were in trend with the production of the last 30 lots and that the quality of the material produced will have lowest levels of impurities, fully bioburden or sterility controlled. The operators fully aware of all the risks at every step of the process which is fully automated and requires minimum intervention by them and also minimum interventions by maintenance technicians and automation engineers. At the end of manufacture a report listing all critical and process control parameters stating highest-lowest, mean values with any alert or action limits listed. A trend report showing the comparison of the lot data value trends for the last 30 lots. A list of all alarms showing acknowledgements with the investigations listed and confirmed closed.  A list of deviations and OOS investigations showing quality impact and closure dates. A list of change controls impacting the lot. Stability data trends show changes from time 0 to end of shelf life. So have you implemented digital 4.0 MES? When implemented was it heralded in the boardroom room and company media as a massive success. If so congratulations to you. Just one questions do you have all of my worlds’ requirements in place? At a recent conference I asked this question of leading industry experts and the answer was not so positive. I heard of stories:

• Where operators still hand fill in batch records, scan them and load them up to the MES system.
• Where only one CPP will have 100% data collected automatically while capability is available using best available technology to collect all critical or control parameters.
• Where some control and critical process parameters are not measured by sensors and so no data is collected.
• Where recipes for Computerised equipment control do not list all changes made and when changes are made without any traceability.
• Where data from manual gauges is documented every day instead of being continuous.

What should be done? Return to offices and have an assessment of your process, data collection, alarm management, audit trails, data trending and sensors in place. If you identify gaps determine if they are critical or control parameters. Consider procedural mitigation actions to reduce the risks and then consider remediation actions such as upgrading sensor management, data collection, analysis, trending, reporting and your quality assurance systems. Also justify addition of data lakes and analysis tools to enhance compliance of your MES system. Bio:

Nigel Cryer has over 40years experience in Biotech, Pharmaceutical and API manufacture. He has been involved in QC computer system integration, GLP database management/ statistical analysis, SAP material management systems and GMP process control systems since the 1990’s. He currently works for Sanofi as a Global Corporate Quality auditor and is currently registering his consultancy company “Bluciela Lifesciences” he can be contacted at nigel.cryer@yahoo.co.uk or via LinkedIn.

The opinions expressed in this article are solely those of the author alone and are based on industry common knowledge from the last 40 years and not necessarily those of Sanofi. Sanofi does not guarantee the accuracy or reliability of the information provided. All references to people or positions are entirely fictional added for dramatic impact. No inference is given nor intended to my current nor past employers.

@2023 Nigel Cryer All rights reserved.

 

By Nigel Cryer | 2023-05-18