Pharmaceutical Automation Roundtable (PAR) - Part 3 - Executive Governance, Electronic Testing Tools, Quality by Design (QbD)

Pharmaceutical Automation Roundtable (PAR) - Part 3 - Executive Governance, Electronic Testing Tools, Quality by Design (QbD)

 
By Bill Lydon - Editor, January 2011
 
This is the third article in a series that is the result of the annual Pharmaceutical Automation Roundtable (PAR). The individual PAR group members have a wealth of practical knowledge and knowhow to share with other participants, truly learning from each other.
 
I had the privilege of attending the Pharmaceutical Automation Roundtable as an observer this last November at Pfizer's Andover, Massachusetts biotech facility. The PAR was co-hosted by Jim LaBonty and James Galloway, both from Pfizer’s central engineering group. Over 30 automation lead engineers from various parts of the world attended the invitation-only, two-day event. In my opinion, this was likely the most knowledgeable group of automation professionals gathered in one place at any one time focused on discussing automation issues. Life Science companies represented in the PAR include Abbott, Alcon Labs, Allerga, Amgen, Bayer, Biogen Idec, BMS, Boehringer Ingelheim, Centocor, Cook Pharmica, Dow, Genentech, GenMab, Genzyme, GSK, Imclone, J&J, Eli Lilly, Lonza, Merck, NNE Pharmaplan, Novartis, Novo Nordisk, Pfizer, Roche, Sanofi-Aventis, Schering Plough, Talecris, and UniLife.
 
The PAR was founded about 15 years ago by Dave Adler and John Krenzke, both with Eli Lilly and Company at the time, as a means of benchmarking and sharing best practices for automation groups among peer pharmaceutical companies. The group specifically does not discuss confidential or proprietary information, cost or price of products, price or other terms of supply contracts, plans to do business or not do business with specific suppliers, contractors, or other companies.   
 
This year’s PAR topics covered the following items:
  • Manufacturing Execution System Projects - Benchmarking
  • Control System Virtualization Approaches
  • Governance Organizational Structures
  • Software Development Environment & Configuration Management
  • Control System – Automation Lifecycle Management and Long Range Planning
  • Electronic Testing Tools & Validation
  • Wireless Networks
  • Disposable Technology and Automation Implications
  • Control Loop Operating Modes – Operator use of Auto & Manual modes relative to Safety
 
The structure of PAR is to discuss a topic and then attendees respond to 3 - 5 questions.
 
Executive Governance
 
One PAR member started the discussion by relating their experience on executive governance. He has been the lead on this in their company for the last three years. The process was started with formation of a steering committee of vice presidents including IT, quality, primary operation directors, and global engineering.  Automation people are part of the Technical Operations Information Management group. They have built on the company’s established process automation standards to create MES, data historian, LIMS and methods execution standards to successfully deploy the standards at sites in a highly consistent manner. A key part of this is standardization on a document management package. He noted that implementing governance makes needed changes highly visible to business management and leads to planned funding for required changes. Any automation or IT project that impacts sites are now governed through one process.  This has been a huge benefit. They have done more projects in the last three years than in previous years.
 
Comments from the PAR group
 
Keeping information management out of automation is not a sustainable model.
 
Use the desktop support group at the site to aid support and help maintain PC-oriented functions, such as historian and patches.
 
Manufacturing IT has various meanings from plant network management to production.
 
The function of manufacturing IT varies including none, ad hoc, and well organized.
 
Architecture templates are used for each system (examples: batch, LIMS) based on standards including S88 and S95.
 
Introducw S88 to scientists that develop recipes so they have a common terminology and understanding.
 
In-house service groups are leveraged with outside contractors.
 
Site groups are getting smaller and require more central support, but cost allocation to sites is a “political football.”
 
Achieving 24/7 support requires 5 people for onsite coverage and these people also perform continuous improvement and process automation project refinements.
 
My Observations
 
Generally, these automation people have good working relationships with IT departments. I think forwarding the concept of Automation IT puts into perspective the fundamental difference between business IT and the unique needs of process automation.
 
There is tension between outsourcing and keeping automation support functions in-house. Outsourcing can be attractive on a short-term, pure cost basis but there is a strong case to be made that onsite, in-house support people can also do continuous improvement, resulting in a higher return on investment. The later takes a more sophisticated management analysis.
 
Electronic Testing Tools
 
Another PAR member discussed their experience implementing electronic validation and testing tools, noting this has yielded major savings. The goal is to eliminate paper by going electronic for a number of items including requirements, traceability, test plans, test protocols, test reports, deviation reports, and electronic signatures. This was a big paradigm shift for the quality group which must buy in for this to be successful.    The benefits of the project reduced approval times by 80%. The reusability of test plans has been limited but is improving. Test results are available online, thus simplifying global review and speeding up the process.   They have eliminated paper archiving that also has saved physical storage space. 
 
Comments from the PAR group
 
Keeping paper around carries more risk than electronic documents becasue paper is harder to secure.
 
You cannot enter a deviation in our system without putting in a comment - the system will not let you proceed.
 
Need alignment of validation processes at all sites.
 
Vendors are often not willing to provide FAT/SAT tests electronically.
 
My Observations
 
The consensus seems to be that electronic documentation is straight forward technology that saves time and money.
 
Quality by Design (QbD)
 
Another PAR member led the discussion on Quality by Design - a systematic approach to development that emphasizes product, process understanding, and process control. This is a model-based approach to accelerate product development and integrated product and process design. The tools used are Multivariate Analysis (MVA), Design of Experiments (DOE), and Process Analytic Technology (PAT). Process models are developed through parametric analysis. 
 
Process control is not the same as process automation. Automation is intended to remove human intervention for repetitive sets of instructions that involve simple logic of known events. Process control is intended to manipulate the parameters of a given process to compensate for disturbances or change entering the system.
 
Comments from the PAR group
 
We are trying to determine the relationship of all the variables and where we want to run optimally. It’s difficult to do that because you can’t measure a lot of what is going on at a cell level. We are striving toward understanding the critical process parameters to achieve better control. If the process people can really determine this we can really improve control.
 
We are dabbling in QdB at this time but are moving in this direction.
 
Process Data Historian is important to help facilitate QdB.
 
In a recent startup of a finish/fill facility they used Design of Experiments of a production/filling line to determine rate of speed guide settings, filling speed operation, and other items to determine optimal settings. The overall startup went more smoothly.
 
My Observations
 
Model based control has become much easier to accomplish, and at lower cost.
 
Summary
 
The Pharmaceutical Automation Roundtable is a terrific event and I am sure attendees gained a number of ideas. The next article covers the group’s thoughts on Wireless in Manufacturing.
 
Links to the other articles in this series: