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Pharmaceutical Manufacturing and Packing Sourcer

Bigger and Better

Data – and its management, integrity and security – is the essential component underpinning product quality, consistency and safety objectives for pharmaceutical manufacturers. This is the key area that brings together and supports optimised production performance and automation technology capability, such as data visualisation, to help drive operational efficiency, product safety and strategic planning targets.

Data’s Influence

We live in a data-driven world and its profound influence cannot be ignored. Big data is now widely referenced across various business sectors, including banking and chemical production. It is acknowledged as an all-encompassing term for any collection of datasets so large and complex that it becomes diffi cult to process them using traditional applications.

The growing importance of big data as a critical element within the pharmaceutical manufacturing process cannot be underestimated; it forms the central link that enhances the integrity of a pharmaceutical product which, in essence, is only as good as the data that supports its manufacture. While a number of manufacturing operations in the sector are benefi ting from intelligence data gathering and dissemination, for many, the true potential of data to help meet product quality, operational efficiency and safety objectives is not being truly realised.

Tapping into such potential can drive a number of business gains, such as enhancing strategic production decisionmaking, repeatability and optimisation; assuring product efficacy; lowering costs; supporting qualification and validation processes; and, ultimately, helping to get products to market quicker. Big data can also be used to link together the disparate elements of the supply chain, from R&D through product manufacture and onto patient use. It can help deliver full traceability, from a product’s origins in the science laboratory to prescription at the doctor’s surgery.

With patient safety an essential factor, having data integrity plus an indelible link between R&D functions and the full-scale manufacturing process can only enhance consumer confidence in the industry.

Critical Components

Data is important for three primary reasons. It can underscore regulatory compliance in the manufacturing process; confirm that prerequisite manufacturing conditions have been met; and ensure that quality critical parameters have been upheld and measured throughout production. But data access, gathering and subsequent use is also flexible and varied. It touches upon many of the most critical components of pharmaceutical manufacturing to ensure product consistency during production, guaranteeing product safety and patient confidence, as well as supporting audit responsibilities.

Some of the most important strategic and operational benefits include enabling the appropriate availability and visualisation of data via automation technology; positively influencing production performance; ensuring data integrity; and, finally, helping to meet regulatory requirements for an industry that is scrutinised like no other.

Perfect Timing

The current vogue for those companies embracing data gathering is a tendency to simply collect too much data, and then struggle to ensure that the most appropriate information reaches the right operative at the right time. Taking the next step and adopting automation technology – such as data visualisation and selectively presenting appropriate data back to the personnel who need it – is essential to deliver an optimised, repeatable and efficient manufacturing operation. A good example is that significant improvements in productivity can be made when the relevant people receive the data they truly need, as it can inform strategic decision-making and highlight areas where a change to a process can deliver tangible results.

Visualisation of data can also support continuous improvement programmes, overcome qualification and validation barriers, and drive repeatability of the ‘golden batch’ (production of product considered to have met all set criteria) by putting manufacturing intelligence at the heart of the process. Clear and accessible information in the right hands will only enhance operational efficiencies, and automation technology solutions exist to allow this to prosper.

Production Efficiencies

Data has the ability to help companies measure more specifically and accurately, and thereby drive improvements in the quantity and quality of critical product and production data. Armed with this data, it is possible to carry out increasingly complex analytics, if required, to enhance product quality and production efficiencies. Automation technology overseeing the gathering of data can set new and different parameters that can be measured at the right time, and then stored and retrieved for future use.

In this way, processes can be refined and optimised effectively based on sound measurements and accurate, readily available datasets. It can also underpin continuous improvement objectives by adequately measuring key elements and feeding back into informed decision-making forums. Pharmaceutical manufacturers can ultimately prove that they have made the right product, can confidently justify this claim, and feel secure that the process is open, transparent and, crucially, auditable.

A Clearer Picture

While the availability of data intelligence in the production process is key, the move towards real-time analysis is the next leap forward for the sector. The old method of waiting for the laboured process of sample creation and lab testing to take its course is no longer viable in a highly competitive marketplace, where the cost of a single day’s delay can be counted in hundreds of thousands of pounds. Real-time data capture and analysis means timescales are shortened and quality products are released with minimum delay. Knowledge can be at the fingertips of decision-makers instantly, driving efficiencies throughout the manufacturing chain.

Likewise, the ability to retrieve the operational parameters and repeat the success of manufacturing the ‘golden batch’ removes the human operator element – which can inadvertently result in batch differences – and, with it, potential issues. Data that can inform and populate historic electronic batch records is easily retrieved, scrutinised and used. This can be a central building block to achieve optimised production performance.

Data can also inform other important elements around the production cycle, such as binding together information to form a holistic picture of the entire production process and surrounding environment. Aspects of building management data can be monitored and captured so that operating conditions can be looked at – for example, how much power was required during the manufacturing process and utility use? And how much has it cost? In addition, other condition-linked questions around elements like the humidity level, or the sanitisation or cleaning process, can all be answered swiftly.

By linking data from the actual manufacturing records, the prevailing environmental conditions and the use of support services, it is entirely feasible to derive a true cost of manufacture, and thus a much clearer and informed picture of the entire production process. It is likely that many pharmaceutical manufacturing operations would currently struggle to articulate the true cost of their product manufacture – but this is a situation that can be rectified.

Endless Possibilities

Future data technology advancement opens up many more possibilities, especially when considering the potential of virtual data storage verification and cloud computing – data solutions that offer infinite answers and are already in use in many other sectors.

In the pharma industry, data growth will continue to be generated from several sources, including manufacturers’ R&D processes, the retail and distribution chain, patients, and even caregivers. Essentially, using these myriad data sources will help companies better identify new potential drug candidates and develop them into effective, approved and reimbursed medicines more quickly. Two areas that are particularly likely to benefit are as follows:

New Drug Pipeline
Access to data that is consistent, reliable and linked seamlessly is one of the biggest challenges currently facing pharma R&D departments. However, R&D must continue to use cuttingedge tools – including sophisticated modelling techniques such as systems biology and high-throughput data production technologies that produce a lot of data quickly. This wealth of data and improved analytical techniques will underpin and enhance future product innovation and help to feed the ever-important drug development pipeline.

Data Sharing
To a large degree, many pharma companies are saddled with legacy systems containing disparate data streams. Increasing the ability to share such data to form a holistic picture requires both the rationalisation of and connecting together of such systems – many of which may have been in place for years.

There is also a shortage of skilled, in-house personnel equipped to develop the technology and analytics needed to extract maximum value from the existing data. While this is a real challenge for the industry, working with knowledgeable technology vendors in the sector can ensure the connectivity needed to link systems together is achieved, and the subsequent data that is captured can drive real operational benefit.

Becoming a Reality

The ability to manage and integrate data generated at all stages of the pharmaceutical manufacturing value chain, from product development to real-world use after regulatory approval, is a fundamental requirement to allow companies to derive maximum benefit from technology trends. Data capture, use and analysis are the foundations upon which value-adding analytics are built. Effective end-to-end data integration establishes an authoritative source for all pieces of information and can accurately link disparate data, regardless of the source.

Technology exists today to make this a reality for the industry, and ensure that data management, integrity and security truly underpin product quality, consistency and safety. Pharmaceutical manufacturers that do not embrace the real advantages that intelligent data use can bring run the risk of being left behind, as competitors invest in a future where data will be king.

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Alan Johnston is the Pharmaceutical and Life Sciences Business Manager for Siemens UK & Ireland, a leading global supplier of industrial plant and software, manufacturing automation and drive technologies to industrial customers across the UK. His career began as an Instrument Artificer Apprentice with Imperial Chemicals Industries, before moving into process automation projects and solution delivery within the chemical, oil and gas, and pharmaceutical industries, latterly supporting HQ on global projects and initiatives. Subsequent roles have taken Alan into sales, key account management and consultative positions. He holds Chartered Engineering status and is a member of the Institution of Engineering and Technology.
Alan Johnston
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