Automated Formulation Tracking Ensures Accuracy, Saves Materials and Expense
Thomas Holzer,
Market Manager Chem/Pharma
Business Unit Standard Industrial
Mettler-Toledo AG

Pharmaceutical formulation and manufacturing are complex processes, and complete adherence to government guidelines and accuracy in the pharmaceutical preparation is paramount to success. With every bad batch affecting a manufacturer's bottom line, a systematic, automated way to document formulas and track raw materials can help reduce bad batches, rework, and disposal costs for significant time- and cost-savings.

In our modern world, most pharmaceutical companies still rely on manual processing, in whole or in part, for product manufacturing. Even when guided by highly detailed paper-based systems, these manual processes are subject to human error. Tracking raw materials in particular may be troublesome in these paper-based systems. Without warnings that critical(and often expensive) ingredients are going to expire, entire lots may need to be thrown out, creating not just costly materials loss but added disposal expense. In addition to occasional bad batches caused by human error, these high-volume errors further degrade a pharmaceutical manufacturer's margins .

However, arobust, detailed, and configurable formulation and tracking software system that can either stand alone or be easily integrated into a manufacturer's enterprise resource planning system can help achieve significant materials and cost-savings by providing complete inventory control, ensuring rare or costly raw materials are used within a particular timeframe to maintain maximum potency. It can also automatically prompt operators with detailed work instructions to further avoid bad batches, rework and disposal costs (and keep manufacturers from running afoul of regulatory bodies and the customers who rely on their products).

Managing Recipe Creation & Dispensing
Appropriately designed formulation and dispensing software that help provides this kind of surety and traceability complements a pharmaceutical manufacturer's current processes. Ideally, it works alongside current processes, providing an electronic repository and centralised database without compromising the flexibility that is so critical in today's fast -paced and rapidly-changing pharmaceutical marketplace.

Formulations can be input and stored for easy recall. The software should also provide detailed, easy-to-understand work instructions on a computer interface. This ensures operators know their next steps - including which ingredients to use, how much of each one to dispense, and any additional processing that needs to occur in a particular processing sequence so that downstream results maintain required accuracy and potency.

The automatic recall of stored information provides much-needed consistency in the heavily-regulated world of drug development and manufacturing. Audit trails, electronic signatures, and device identification within the confines of a userfriendly, password-protected workstation with an electronic formulation and inventory management system as its foundation goes a long way towards satisfying essential standards, such as the US Food and Drug Administration (FDA) 21 CFR, Part 11, as well.

With a robust enough solution, workflows can be controlled in such a way so that operators know at a glance which orders have been completed, which are in process, and which await processing. This ability to accurately control workflows can enhance throughput and reduce time-to-market while still maintaining the kind of accuracy that is so crucial to manufacturing compliance and end-user safety.

Maximising Inventory Management and Yield
The bedrock of formulation potency is accurate inventory management. Softwaremanaged inventory control can help a manufacturer know exactly what is in its warehouse, when it arrived, and how long until it expires. Raw materials can be tracked from the moment they are received to the time they become a finished product heading to the clinic or marketplace. Current stock can be assessed immediately without having to consult multiple logs and personnel, making time-consuming collection and spreadsheet input of inventory reports a thing of the past. These changes dramatically improve information flow between a manufacturerís warehouse and dispensing systems .

With this improved flow of information, raw material use is maximised. Production yield also increases. Establishing guidelines in the software, such as First In, First Out (FIFO), and ensuring operators use the software for appropriate guidance when it comes to inventory management can help a manufacturer fully utilise its inventory and maximise yield from expensive and even sometimes rare or hard-tosynthesize materials.

Additional hardware pieces, such as printers and barcode scanners enable this kind of robust tracking for optimum processing speed and inventory management accuracy. Making sure these hardware pieces are wireless help enhance portability. In essence, the ability to track and trace goes wherever the materials are, with data continuously communicated to the central repository so that an ingredientís location is tagged and noted, offering what is perhaps the easiest materials tracking and tracing methodology available today.

Passing Audits, Integrating Equipment
Though formulations and processes differ from drug to drug and manufacturing company to manufacturing company, the need for validation to meet regulatory standards and pass audits is universal. The ability to track and trace enhances the ability to pass audit, ensuring a company can easily show when materials were received, that they were appropriately quarantined until requisite quality control checks could be made, and that they were only released into production after the quality review occurred. The ability to monitor, track, and control each phase of the production process validates every facet of the formulation process in real time.

Being able to track and trace all these activities also necessitates the tracking and tracing of all weighing and calibration activities. Ensuring service records and calibration activities are also included in materials -management. Handling logs helps further show that manufacturing due diligence is occurring and formulations that the company is turning out are accurate, potent, and safe.

One Company's Implementation Experience How might the use of an electronic, softwarebased track and trace data repository look in a day-to-day pharmaceutical manufacturing environment? Are the benefits more than just word on a page? Do they justify the expense of purchasing and implementing such a system?

One US-based pharmaceutical company that specialises in custom formulation development and analytical services to a worldwide group of pharmaceutical, biotech, academic and veterinary clients primarily for dosing in capsules and tablets decided that its legacy paperbased formulation-management system needed an upgrade. But because their work is primarily in custom formulation , manual processing would remain a critical component of their operations. Flexibility in their processes was key - but they also needed to eliminate transcription errors and spreadsheet entry slip-ups to improve their overall accuracy and consistency.

The company also wanted a system that would allow raw material, lot and batch numbers to be printed on a ticket with the time and date of intake, and one that would automatically provide operators with detailed work instructions and a complete understanding of current inventory at a glance. Of course, all new features would still have to provide 21 CFR, Part 11 compliant functions to fulfill FDA requirements as well.

Streamlined Processes and Reduced Costs
By fully implementing an electronic inventory management and formulation software system, the company is now able to manage its inventory resourcefully and accurately. The system they chose ensures they can weigh raw materials, track them, and catalog finished products/packaged goods using integrated scales, barcode scanners, and printers.

Automatic potency calculation and batch verification is also giving the manufacturer complete control over weighing activities on a daily basis, all but guaranteeing traceability. The addition of easy-clean touchscreen balances to their processes has allowed them to evaluate raw material batch information in production orders on the spot as well.

Finally, because their tracking/tracing and formulation procedures are now electronic, the company has noted one additional cost-savings. They are buying less paper! All in all, the new software has allowed them to streamline formulation and inventory processes, continue compiling a record of safe, high-quality products, and really focus on what matters to them most: their clients.