Compliance – more than just red tape

Author: Lee Sullivan, COPA-DATA UK

FDA statistics are forcing the industry to identify and implement improvements to its manufacturing processes. In its latest reports, the FDA identified a significant increase in the number of drug shortages reported globally. With 65% of these drug shortage instances directly caused by issues in product quality, it’s clear that if more pharma manufacturers aimed to meet the criteria outlined in FDA and other industry standards, drug shortages and quality issues would certainly become less frequent.

The compulsion to become compliant obviously differs from company to company and standard to standard but one thing is certain: development starts with batch software. The range and capabilities of batch software vary immensely, but there are three factors to consider before making a choice: flexibility, connectivity and ergonomics.

Flexibility

To assist the complex processes of pharmaceutical manufacturing, batch software needs to be flexible. The software should manage traceability of raw materials through to the finished product and communicate fluently with other equipment in the facility. To ensure it provides a consistent procedure and terminology for batch production, the software should also be in line with the ISA-88 standard.

To meet increasing demand for personalised medication, manufacturers are seeking out batch software that is capable of creating flexible recipes, which are consistently repeatable. Traditional batch control creates one sequence of each process-specific recipe. While this model may be ideal for high volume manufacturing where the recipe does not change, today’s pharmaceutical production requires more flexibility.

To remain competitive, manufacturers need to provide compliance in a quick and cost-effective manner. Modern batch control software ensures flexibility by separating the equipment and recipe control. This allows the operator to make changes in batch recipes without any modifications to the equipment or additional engineering, thus saving the manufacturer time and money.

Connectivity

To avoid complications, manufacturers should choose independent software that supports a wide range of communication protocols. COPA-DATA’s zenon, for example, offers more than 300 high-performance interfaces that function in accordance with the 'plug-and-play principle'. This makes it easy to implement and the user can start to collect, process and monitor production data straight away.

The communication model of the batch software extends upwards to fully integrate into manufacturing execution systems (MES) and business enterprise resource planning (ERP) systems. This links the raw material from goods-in through to the finished product at the customer’s site. The strong communication platform includes all layers of a production environment and extends to these systems.

Having no association with specific hardware providers ensures that regardless of the make and age of equipment, the batch software will be fully compatible and integrate seamlessly. Using this high level of connectivity minimises disruptions and quality problems, while also allowing pharmaceutical companies to collect data from the entire factory to archive digital records and ensure compliance across the processing line - allowing manufacturers to establish a fully connected smart factory.

Ergonomics

Lastly, understanding and using batch software should be stress free. As the pharmaceutical industry becomes more complex and more manufacturers begin exploring the realms of smart manufacturing, factory operators should be able to control and change batch production without complications.

By using software fitted with clear parameters and access levels, operators gain the ability to create and validate recipes, monitor the execution of production and review the performance of industrial machinery – without accidently altering or changing existing recipes and data. Reducing the amount of software engineering makes the operator’s life easier and minimises potential problems that could arise.

The benefits of complying with various industry regulations and standards do not stop with an enhanced Quality Management System (QMS). More customers will buy from you because you appear more reliable and your supply chain will see improved production indicators, such as increased OEE, reduced wastage, reduced recalls. On top of all of these benefits, you also improve product and thus patient safety.

To comply with industry standards, pharmaceutical companies should take steps to modernise their manufacturing processes, beginning with upgrading their batch control software. Anything else would be like putting the cart before the horse.