The Pharma Challenges – The demands and difficulties in pharmaceutical automation
Challenge: About 15 years ago, the emphasis in pharma production was all on validation. Because of that, automation engineers in pharma were really good at paperwork and change procedures. In a lot of cases they never learned how to be true engineers to make their processes run better and find improvement opportunities.
In the past, Engineering has had significant focus on compliance and validation issues, in a ‘validate all’ culture which instilled fear for all people concerned. But the world keeps turning, things evolve; zenon has a lot of integral functionality which is brought to life through parameterization, which brings the product to a GAMP software category 4. With this you have complete solutions created in a validation efficient environment. The FDA is also evolving from this ‘validate all’ culture, in-line with the ISPE GAMP 5 guidelines, applying risk analysis to find and focus the validation activities on the regions of the automation which affect product quality and security. The zenon Pharma Edition looks to aid this design stage with automated documentation tools, project versioning, and project comparison, which highlight which changes have been made to a project, clearly stating what has been affected by the change, and so focus the attention of validation to only critical areas, thus reducing the uncertainty and bringing higher quality as a whole.
Challenge: More than one fourth of the errors could probably be avoided by implementing automation.
Following the GAMP 5 risk assessment, non-conformity or risk of quality failure is assessed through a risk matrix, where Severity and Probability of failure determine a risk class, which is assessed with Detectability to determine the probability of failure. The task of the automation system in concept and operation is to make aware Severity, Probability, and Detectability. Through highly visible processes these three markers can be determined and qualified through clear understanding and identified as Critical Quality Attributes. High levels of visibility and reporting bring certainty to detecting determinable errors. COPA-DATA has a strict Quality Control structure, with procedures and documentation tracing development of each module in our product range. This library of functionality is enabled through parameterization. This means projects built on zenon technology, have a high level of quality and reliability, all pushing down the risk of non-compliance.
Challenge: Automation engineers should start thinking about a holistic change that will eliminate problems and issues.
Regulations in the recent past have segregated automation, in order to put boundaries on processes. The lack of simple communication mechanisms created isolated non-deterministic production environments. zenon offers simple to configure networks, and simple to configure automation solutions, which can control, acquire, communicate, and present information. Individual machines can now be lifted in to processes, and process-wide assessment carried out, with process audit-trail, alarm, and reporting. Holistic solutions for holistic operation.
Challenge: People in automation need to improve their way of translating their work into business value for Managers.
The zenon Product Family aims to touch on all operations in the control pyramid, linking layers, accessing all areas of production and automation, bringing systems and people together. Real time information can be processed and focused to a specific person’s usage. This puts automation into all operations within the production environment, translating production operations into: Business measurable data, Operation management efficiency, Operator productivity and motivation. All from the automation and engineering backbone.