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The life science segment is one of the oldest at Novotek and has always been one of our largest segments. Novotek has done solutions for all major companies in the segment including Pfizer, Astrazeneca, Merck, Johnson&Johnson and Novo Nordisk. We do complete "turn-key" solutions with or without validation requirements.
The products we have in our solutions are to all major extent, CFR21 Part 11 certified with modules for audit trail, security and reporting tools. We see this as very important in order to secure the future upgradeability without jeopardizing the validation.
Our ISO certified QA system has been audited several times by pharmaceutical companies with great results. We are proud to be able to deliver complete projects based mainly on standard components.
How We Address Your Challenges
As conditions in both production environments and health care delivery markets become tougher, it's increasingly important to focus on production operations as a source of competitive advantage. With a suite of solutions designed to yield deep insight into how ingredients and equipment interact, Proficy provides an ideal platform to address needs ranging from basic batch execution and control through process analytics, to work process management in support of CAPA regimens.
Get insight into product flow by tracking production against specifications, equipment and schedules. Get access to detailed tracking data for comprehensive by-batch or long-term, analysis and visualization.
Whether you are performing statistical process control or process capability analysis, generating control charts or performing a product review, Plant Applications Quality gives you the data access and tools you need.
The Food and Drug Administration in early 2000, began looking at ways to help companies improve their manufacturing processes while remaining in compliance with regulations. The result was two guidance documents: PAT and cGMPs for the 21st Century, we explore some aspects of their implications below.
The Increased Need for Traceability in Today’s Market
Traceability has always been a requirement for life sciences companies. The review of batch reports and testing of individual batches – and the long hold times that have come with them -- have long been a fact of life.
But recent developments have made the necessity for traceability and genealogy even greater. For one thing, the Sarbanes-Oxley bill of 2002, intended to reform accounting practices and produce accounting transparency in publicly traded companies, has had effects that have reached down to the plant floor. IT systems from ERP down to plant-level process controls have had to be revamped to meet the bill’s requirements. What’s more, the threat of product recalls in recent years has added to an increased need for visibility into your manufacturing process – you have to be able to demonstrate quickly exactly what went into any given batch of product.
GE Intelligent Platforms Production: A Solution for Traceability and More
GE’s Plant Applications Production solution is a powerful software module that provides the end-to-end visibility into your process and products that you need. Part of the larger Proficy Plant Applications Collaborative Production Management suite, Production provides access to the information you need about source, quality, and personnel – from the raw materials to the finished tablet. Get insight into product flow by tracking production against specifications, equipment and schedules. Get access to detailed tracking data for long-term analysis, and comprehensive web analysis and visualisation.
What’s more, Production benefits your bottom line, not just your regulatory compliance. With Production, you can make in-process scheduling changes to reduce Work-in-Progress and standing inventory. You get insight into not just the historical path of a product, but exactly where every things stands in real time, so you can make the decisions that boost efficiency and reduce waste.
Quality Initiatives – A Better Way to Make a Better Product
Life sciences companies have always made extremely high quality products – FDA oversight makes sure they do. But they have long tolerated less-than-perfect processes for manufacturing those drugs – long lead times, slow time-to-market and other inefficiencies are the norm in the industry. High scrap rates and rework are common.
As firms come under pressure to cut costs, most have implemented some kind of quality initiative to rectify these problems. The exact initiative varies from company to company – some focus on Lean Manufacturing, others on Six Sigma and Right First Time efforts – but they all have in common the goal of improving the quality of their process and the consistency of their final product by making ongoing process improvements, which can lead to substantial savings.
Challenges to Quality Initiatives
As with any organisation, there are challenges. The constant struggle for resources means that decision-makers have to be able to demonstrate clear benefit to the company’s bottom line in the short term to justify the expenses.
What’s more, whatever changes they make must be done while remaining in compliance with FDA regulations. Any gains in consistency and efficiency would be more than offset by the consequences that can result from FDA warning letters, 483s and failed quality audits.
GE Intelligent Platforms Quality: The Insight You Need to Improve Quality
GE Intelligent Platform’s Plant Applications Quality solution is a powerful software module – part of the larger Proficy Plant Applications Collaborative Production Management suite – that supports and enables your quality initiative. Plant Applications Quality tracks and monitors your product and process quality in real time using data collected from all sources – manual and automatic. Reason codes, process values, research notes as well as recipe, batch, lot and materials information all are captured and analysed to identify root cause problems. Alarms are exposed at data entry and data acquisition time, and it even has electronic signature capabilities.
Whether you’re performing statistical process control or process capability analysis, generating control charts or performing an annual product review, Plant Applications Quality gives you the data access and tools you need.
- Plant Applications Quality Management
A New Era of Operational Excellence
For the past 30 years, life sciences companies have been among the most profitable manufacturing entities in the world. Blockbuster drugs have delivered exceptional profits and, for a while, made these companies seemingly impervious to economic downturns.
But new challenges are facing the industry. By 2008, no fewer than 19 current blockbuster drugs are facing patent extinction, meaning they’ll face competition from generics. What’s more, government price controls and the counterfeiting and reimportation of drugs are cutting into potential profits. And the costs of research and discovery of new drugs go up with every passing year. To meet these challenges, life sciences enterprises are having to look at improving their manufacturing practices to increase efficiency, cut costs and use manufacturing as a competitive advantage.
Lock it Down: The Way It Was in Drug Manufacturing
Historically, pharmaceutical companies have excelled at one thing: discovering new drugs. More recently, marketing has become a second area of expertise. But the manufacture of those drugs was an afterthought, a secondary capability. Once the quality of the product was established, the successful process and technology were “locked down” and never changed. Because of intense oversight by the FDA, there was no incentive to improve the processes – any potential savings from improved productivity were far outweighed by the potential liabilities of an FDA citation or penalty that came as a result of a change.
Because of huge profits, enormous inefficiencies were tolerated. While the manufacture of a certain drug might require only one day, actual elapsed time with testing and waiting could take up to six weeks or more. Today sedentary inventory, including work-in-progress, amounts to billions of dollars in the industry. Long lead times, disconnected processes, slow changeovers, and low resource utilization – sometimes as low as 30% -- are the standard throughout the industry.
The FDA: Partnership for Operational Excellence
The Food and Drug Administration, which oversees the industry, recognized these problems, and saw that its traditional “catch-and-punish” relationship with companies was part of the problem. Beginning as early as 2000 it began looking at ways to help companies improve their manufacturing processes while remaining in compliance with regulations. The result was two guidance documents: PAT and cGMPs for the 21st Century. The life sciences industry has vigorously embraced these efforts by launching a number of initiatives to improve their processes. These include:
- Process Analytical Technologies (PAT), an effort to improve manufacturing processes to make drugs more efficiently and get them to market more quickly.
- Overall Equipment Effectiveness (OEE), a simple but powerful calculation to measure overall process efficiency.
- Quality Initiatives, the utilisation of various methodologies such as Lean Manufacturing and Six Sigma to eliminate rework and high scrap rates.
- Traceability and Genealogy, improved efforts to gain insight into products and processes from raw materials through to finished drugs.
Through these efforts, the pharmaceutical industry is moving to match the efficiency found in other industries, and to achieve something they’d never had in their processes before: operational excellence.