Taming the pharmaceutical validation dragon | Automation.com

Taming the pharmaceutical validation dragon

Taming the pharmaceutical validation dragon

By Robert Harrison,  COPA-DATA

One of the main reasons why the pharmaceutical industry has been very profitable over the last decades is the existence of patent protected drugs. However, the sector is lagging behind in efficiency and sustainability. The patent cliff, rising competition, increasing material and manufacturing costs, and strict compliance of global regulations are additional challenges that pharmaceutical manufacturers face every day.

Most chemical patents expire after 20 years from the date of filing, which is usually set as the start of clinical trials. Over the next five years, the annual estimated sales-value of drugs with patents set to expire is over £150 billion. This puts pharmaceutical companies between a rock and a hard place – becoming more efficient and flexible, while still complying with regulations to ensure product quality and safety. The companies that will survive are the ones that manage to make their quality management culture smarter and more malleable.

Intelligent automation software
There is no doubt that automating the manufacturing process plays a key role in making a company more efficient. But automation is of little use without a communication system that allows a smooth collaboration between research and development, shop floor production systems and the rest of the business.

Industrial automation software like zenon can help enhance the control function and data logging, processing and archiving of data within the SCADA system. It can automatically generate live bespoke reports, essential when complying with FDA 21 CFR Part 11 regulations and the Energy Management standard ISO 50001. Finally, intelligent software solutions can increase output, while optimising a company’s key performance indicators (KPIs).

What’s stopping you?
One of the most daunting aspects of new technology is the amount of time spent on implementation and training. The question most companies ask is “will it be worth it?”

What manufacturers often don’t realise is that the best cutting edge industrial automation software is extremely easy to implement, as well as very intuitive and ergonomic to use.

When it is configurable, industrial software eliminates the complexity of writing program code for applications. Programmed code is a process which is not only very complex and time-consuming, but also needs significant validation and quality effort due to the high potential failure rate. Configurable systems are very efficient to validate. Using parameterisation, robust automation solutions are easily implemented in pharmaceutical environments, offering more process flexibility.

Parameterisation allows the designer to create use a function library that covers the engineering challenges faced by the pharmaceutical industry. Setting parameters instead of programming creates a well-defined process and limits the risks. Once installed, the software shouldn’t need further intervention or additional coding.

Another advantage of using best-in-class industrial automation software solutions is their native communication drivers. When the software provider is independent and has no links to specific hardware manufacturers, it means the software can connect directly to the process, regardless of platform and without stopping the production line. Platform-independence and easy connectivity are ideal prerequisites for FDA 21 CFR Part 11 projects.

Anyone who works in manufacturing understands the costs of downtime and how important it is to be able to extract data from different machines without any stoppages, changes or additions to the system.

FDA 21 CFR Part 11
The FDA 21 CFR Part 11 regulation defines the criteria under which electronic records and signatures are considered trustworthy, reliable and equivalent to paper records. Often seen as an overcomplicated procedure by drug manufacturers, the regulation can be easily embraced by using the correct industrial automation software.

The collection of electronic data must adhere to the strict guidelines. Electronic signatures must be linked to the electronics records, all activity must be recorded in an audit-trail, security measures must be in place to restrict access to systems in the regulated environment.

Software products themselves cannot be certified or validated, only the end product or project of the regulated company can be validated. Each operation, event, and critical exception must be documented, recording who, what, why, where and when information. Through the audit-trail it must be possible to reconstruct the complete history of events and processes.

In the case of paper batch records, mistakes can usually be traced back to missing entries or incorrect records. Industrial automation software can simplify the process of logging, archiving and reporting on information from a variety of sources including mobile devices, especially where the audit trail is concerned. Modifications and events at any stage are automatically logged, which ensures secure traceability of all process and operator actions.

Process flexibility and validation efficiency come when using a product that can provide all ‘Part 11’ compliance needs in one software installation, with audit-trail, alarm management, historian, user administration, SQL and reporting. Or, as needed, integrate through efficient communication to other systems.

User administration regulates who can have access to this closed system, restricting usage to authorised personnel through the use of usernames and password verification. Unsuccessful login attempts should be recorded and system lockouts should be mandatory when unauthorized access is requested.

ISO 50001
The ISO 50001 standard reflects sustainable energy management practices within a wide range of industries, including pharmaceutical. The goal is to continuously improve energy performance through a framework of energy efficient strategies and processes. ISO 50001 is a worldwide standard defined through measurable results related to energy consumption.

Visualisation of all the manufacturing activities and stages is crucial when analysing energy efficiency. In order to decide what would work best, you would first need to have an accurate picture of how much each application, process or machine consumes, and how much a system alteration would reduce energy usage.

For example, one of the biggest sources of energy consumption within a pharmaceutical manufacturing line is the air conditioning system. It is common knowledge that by fitting variable speed drives (VSDs) on motors, energy usage can be significantly reduced. The next step, however, is visualising individual energy reduction techniques and their results across the system, in real time. This allows the manufacturing manager to trace the exact benefits of each modification and makes it easier to implement further improvements.

Real time data visualisation plays a key role in increasing staff morale. Seeing the effects of their personal hard-work, and how this directly influences the process, motivation of the initiative gains more and more momentum.

High end functionality, ergonomics, smart data processing and reporting functions are only a few of the ways in which industrial automation software can help pharmaceutical companies become more efficient and competitive.

Embracing new technologies doesn’t mean putting quality or safety aside. On the contrary, it’s one of the best ways to make engineering more efficient, simplify the regulatory process, meet international regulations, and reduce quality violations. Industrial automation software can, in fact, be a pharmaceutical company’s most useful weapon in taming the validation dragon.

About COPA-DATA
COPA-DATA is the technological leader for ergonomic and highly-dynamic process solutions. The company, founded in 1987, develops the software zenon for HMI/SCADA, Dynamic Production Reporting and integrated PLC systems at its headquarters in Austria. zenon is sold through its own offices in Europe, North America and Asia, as well as partners and distributors throughout the world. Customers benefit from local contact persons and local support thanks to a decentralized corporate structure. As an independent company, COPA-DATA can act quickly and flexibly, continues to set new standards in functionality and ease of use and leads the market trends. Over 80,000 installed systems in more than 50 countries provide companies in the Food & Beverage, Energy & Infrastructure, Automotive and Pharmaceutical sectors with new scope for efficient automation.

About the zenon Pharma Edition
zenon Pharma Edition is the industry-specific SCADA solution from COPA-DATA for automation projects in the pharmaceutical industry - addressing the needs of international regulations and their validation processes in pharmaceutical production. Configuration enables integral functionality such as audit-trail, user administration, alarm management, electronic records and electronic signatures; GAMP software category 4 configured projects are easily administered with high end functionality. The specific pharmaceutical tools create a framework for regulated environments. Project documentation and project comparison tools generate validation evidence automatically; therefore project content, behavior and security are reliably managed. With strong communication capabilities, a bundle of functionality such as Batch Control, trending and analysis, historian, SQL, recipe management and seamless integration of zenon Logic – the IEC 61131-3 PLC system – zenon Pharma Edition innovates in a framework of regulation.

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