It was also to become the name of the pharmaceutical company that developed out of the medical drug store in 1923. Dolorgiet GmbH in St. Augustin, near Bonn, now employs around 500 people. For all the current growth and quality targets, Dolorgiet implemented the lot-oriented ERP system from the GUS Group. The solution assists where all GMP relevant processes (Good Manufacturing Practices) have to be optimized, managed and documented.

"We chose the GUS Group because of their proved pharmaceutical competence built up over the last 28 years", emphasized the chemist D. Doll who is chairman of the company. After modernizing the whole production in the eighties and nineties there began at the turn of the new century a reorientation of information processes. It would have been very expensive to modernize the existing, in-house solution. In their search for a future-oriented replacement, Dolorgiet’s main requirement was having an integrated quality management that would cover all their business processes. The reason for this was that the new solution should actively support the mandatory validations now enforced in the pharmaceutical industry.

In their search for new information technology they also wanted to tap to the full the economization potential – for example more efficient use of raw materials and to cut down warehouse stocks to reduce capital lock up. Another important factor for the new business solution was to achieve the same quality niveau that they reached when modernizing their production.

This quality alignment is extremely important when manufacturing todays’ medical preparations (anti-psychotic drugs, heart-circulation compounds, gastrointestinal preparations, anti-rheumatic drugs, and antibiotics) as well as brand name health care articles. Dolorgiet are also highly regarded by outside contractors for their expertise in processing the pain relieving and anti-inflammatory substance Ibutropfen in pills, creams and gels. This means that the company’s quality-oriented processes not only have to be effective for their own manufacturing processes but also when working in partnership with other pharmaceutical companies.

For this purpose the tasks for development, production, marketing, sales and logistics have been integrated at Dolorgiet into one functional unit using the GUS software. This also creates the conditions to compete successfully in the market with new preparations: In the last three years alone Dolorgiet has brought out six new products onto the market. They have not only extended their product portfolio but also opened up new indication fields.

They have around 30 basic recipes that expand to several hundred products. Their annual production adds up to around 12 million units (blister packs and tubes). Also differing presentation forms as well as national package inserts and packaging have to be taken into consideration as Dolorgiet preparations are currently being sold in 30 different countries – focused mainly in West and East Europe and the Middle East. Sales and marketing to South America and Asia is currently being expanded.

In order to serve this market around 100 lots, each with a volume of up to one ton, are being speeded through all the GMP required manufacturing processes each month with help from the software. For example, the incoming raw materials are booked into stock by the ERP system but are held in quarantine status until the final release by quality control. This means that the coverage of warehouse stack can be meticulously accounted for and non-released stocks cannot be reserved for use.

The laboratory has also been integrated into the business processes. The implemented Laboratory Information System – GUS-OS Laboratory – receives the necessary lot information directly from the ERP system. Conversely the test results from the laboratory activates the tested lot being released from stock.

The high-level warehouse is spread out over 8,500 square meters and has around 7,000 pallet locations and from there the material is brought into the production clean room and then prepared for further processing. Lots are then weighed according to the stored recipes. Subsequently in preproduction (semi solid products and liquids) creams and juices are manufactured or the materials are granulated and compressed and passed on to be processed into tablets or pills. The relevant routing plans are also available in the ERP system. They are the basis for the resource planning for this finishing process. Between 40,000 and 100,000 tablets can be processed here every hour.

Creams and juices are sent directly to filling but tablets then have to be coated after going through the in-process control – weight, thickness, tensile strength/brittleness. After this time consuming process – dispensing can take up to 1.5 days – the tablets are then blistered. The drugs only leave the clean room conditions for end packaging after they have been securely enclosed in tubes or blister packs

At this point quality relevant information from the manufacturing processes (mixture, compression, coating) is entered into the GUS solution at the lot level. Dolorgiet has access to exact information at every point of the production regarding the status of their medications. Finally the lots are packed and the ERP system ensures that the correct packaging materials and package inserts are used.

"Thanks to the solution from GUS Group not only did we achieve improved GMP documentation for our quality processes but we now have completely integrated lot-orientation. This starts at incoming materials, then to the process steps in manufacturing, right up to incoming finished products for packaging and order picking", explained Hans-Martin Kühn who is in charge of Finance and Controlling.

The meticulous lot tracing also helps Dolorgiet to manage stocks and purchases more efficiently. Because they know exactly how much stock is needed for every processing step the company can schedule more efficiently: Dolorgiet can therefore reduce stocks and produce in accordance with requirements.

Replacing Dolorgiet’s own software solution with the ERP system was also a challenge for the GUS Group team. The main challenge was to reproduce the existing processes with a standard solution that would cover all the company’s individual features. "This is where an in-house development has certain advantages", argues Kühn. "However in adapting the software to our requirements the GUS team carried out excellent work." They now have the advantage of a unified, integrated system for all functional areas. The solution's distinct sector alignment also achieved additional quality. Whoever wants to manufacture high quality, safe medications cannot settle for mediocre information technology.