Taming the validation dragon
It takes an average of twelve years and over £200m to get a new drug from the laboratory onto the shelf. Robert Harrison, pharmaceutical industry manager of COPA-DATA, explains how appropriate technologies can help, rather than hinder, essential regulatory compliance.
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. The companies that will survive are the ones that manage to make their quality management culture smarter and more malleable.
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 can help enhance the control function and data logging, processing and archiving of data within the SCADA system.
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.
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.
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.
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.
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.