For more than 20 years, the FDA has clearly defined its expectations for the accuracy, reliability and truthfulness of all data and information collected by drug manufacturers. Most recently it updated its guidance on ensuring data integrity and compliance with current Good Manufacturing Practice (cGMP).
Regardless of changing regulations, collecting and documenting sound and accurate data is crucial to ensuring the safe use of drugs or medical devices by consumers.
Yet, from the research lab to the manufacturing plant, collecting and documenting quality data is easier said than done. When working against deadlines and trying to efficiently optimise expensive GMP suite real estate, data collection can be a time-consuming and sometimes error-prone process that can cause project delays or projects that fail altogether.
As workers walk across the lab to enter data, they’re contributing to motion waste which not only impacts timelines, but also data integrity
For this reason, biopharma firms are moving away from manual data collection and paper-based production records since they need to be able to electronically capture and share data.
To accomplish this, they’re using Lab Information Management Systems (LIMS) in the labs, to manage sample tracking, inventory, system configurations, test results, audit trails, quality control (QC) data, sample/analysis count, instrument calibration and other data that accounts for GMP requirements. Likewise, they’re using Manufacturing Execution Systems (MES) in the suites, to monitor, document and control the process of manufacturing goods from raw materials to finished products and obtain accurate electronic batch records.
These systems allow them to store data as electronic files, as well as identify issues immediately, such as inaccurate or duplicate data or any other anomalies.
For staff who are scientists first, electronically capturing data can be a tough transition
Automating data collection and documentation not only reduces errors and enables data integrity, it also boosts productivity so firms can get on with vital research, discovery and production instead of spending inordinate amounts of time entering or reviewing data. This type of automation is the gateway to the next-generation in manufacturing, which is known as Industry 4.0. In pharma manufacturing, Industry 4.0 will encompass the use of interconnected, data-driven systems, sensors and eventually autonomous systems.
As a result, according to McKinsey & Co., “in the next five to ten years, new technologies that characterise Industry 4.0—from connectivity to advanced analytics, robotics, and automation—have the potential to revolutionise every element of pharmaceutical quality control labs.” And, its research found that these technologies typically boost productivity between 50% to 100%.
Additional productivity busters
While automating data collection and documentation processes will be the key driver to greater productivity, it also can contribute to motion waste across the cleanroom. As workers walk across the lab or plant floor to enter data into a system residing on a fixed workstation, or to print out key documents, they’re contributing to motion waste which not only impacts timelines, but also data integrity, since data can be lost on the way to the workstation.
Mobilising the data
One of the world’s largest pharmaceutical manufacturers realised that the key to optimising the growing array of digital tools required in pharma, such as MES and LIMS, ERPs and project management systems, without causing motion waste, is to mobilise them.
Before this, the pharma firm first considered installing fixed workstations across the site. Yet in addition to the cost of the workstations, a bigger cost would come from having to completely shut down cleanroom operations as the workstations were being installed – this cost would amount to millions of dollars in downtime. Not only would this installation be disruptive, but the motion waste it would cause, when employees had to traverse the lab or plant floor to enter data, would significantly impact productivity.
As a result, the pharma firm chose to equip its staff with mobile, battery-powered GMP workstations that housed a PC, monitor and scanner. They used these workstations to perform data collection on their Electronic Batch Records (EBR), allocate inventory and track samples during a manufacturing run. This eliminated any motion waste created by walking to a fixed workstation and it reduced human errors by bringing data collection to the point of task.
Below are key considerations for bringing computing power to the biopharma lab or manufacturing plant.
Make digital tools as easy as possible to use
Especially for staff who are scientists first, electronically capturing data can be a tough transition. Yet, the easier it is to do, the more receptive staff will be. It’s important to take into consideration the inconvenience of moving to a fixed workstation, or the frustrations of losing laptop power. It’s important to listen to and address user frustrations.
Provide staff with everything they need in one place
Another way to minimise motion waste in the cleanroom is to make sure staff entering data has everything they need at their disposal, such as PCs and scanners for executing MES or LIMs applications; as well as remote battery chargers.
Consider the power source
When different types of electronic devices are mobilised in the cleanroom, a key concern is power. It’s important to have advanced battery power that can withstand long shifts, with 100% uptime. Staff are not allowed to leave a cleanroom suite during a manufacturing run and if a battery needed recharging, they would need to stop the entire production run and scrap whatever products were made, amounting to hundreds of thousands of dollars in lost batches or products.
Digitalisation and the shift to Industry 4.0 is taking root in pharma, and enabling greater innovation and productivity. It’s important, however, to consider how these digital tools are delivered in the cleanroom to not only ensure efficiency, but compliance to cleanroom health and safety requirements.
