versiondog: Indispensable for the efficient development and production of narcotics

For Yichang Humanwell Pharmaceuticals, China's largest narcotics manufacturer, the devil is in the detail. To ensure that the entire production process runs smoothly, versiondog accompanies the strictly regulated production processes.

The use of narcotics can make the difference between life and death. The specifications that must be complied with in the manufacturing of anesthetic drugs are correspondingly strict. From the selection and the dosing of the raw materials, the speed of the machines, the temperature in the production hall, the duration of production to packaging, storage and transport - every step of the manufacturing process requires a high degree of stability and precision. A single mistake can result in the disposal of an entire batch of medicines worth millions of RMB. Since 2020, versiondog software from AUVESY-MDT has been reducing the risk of failure and errors at Yichang Humanwell Pharmaceuticals, the largest manufacturer of anesthetic drugs in China.

Centralized data management for secure production compliance

For pharmaceutical companies, safe and lawful production is a priority. In particular, the production of narcotics is not only result-oriented, but must be strictly controlled. This includes that all plant parameters must be set very carefully during the production process and executed in strict accordance with the process recipe. In the past, these processes had to be carried out manually at Yichang Humanwell and every small change had to be checked, manually recorded and documented at several levels. To make matters worse, it is difficult to control whether and which system parameters change in the actual production process.

Yichang Humanwell was therefore looking for a solution to simplify compliance with production regulations. In 2019, the head of the information center at Yichang Humanwell came across versiondog at a pharmaceutical machinery trade fair in Sichuan. A software that centrally manages various devices, automatically backs up data and records all program changes. In 2020, Yichang Humanwell introduced versiondog. The software from AUVESY-MDT is used in a new production line for freeze-dried emulsions, which was built in 2021 with a total investment of more than 200 million RMB and includes about 70 machines. From 2022 it is planned to gradually expand versiondog to all production lines in the newly built global headquarters.

Ensuring Compliance

When all pharmaceutical process recipes and equipment formulas are entered into the system, versiondog can manage them centrally and ensure regulatory compliance more efficiently. It can also be used to determine whether the device parameters were changed during the production process and what they looked like before and after the change. A function that significantly increases the efficiency of quality assurance officers. Because instead of having to check the operation of the individual machines and test the production conditions on site, they can access the change log of the devices from the office with versiondog. In the event of a problem with a product, they can visually check whether and which changes have been made to the relevant parameters. Or in other words. You can quickly trace the problem back to the source of the error.

Storage of multiple versions for more efficient research and development

In addition to the safe and compliant manufacturing of medicines, another benefit of versiondog quickly became apparent. The software accelerates the development of new products. Because with versiondog, the recorded device parameters such as temperature, pressure or speed at which the system is operated can be compared simply and easily. Parameters that are so-called equipment recipes in the pharmaceutical industry. Together with the process recipes, such as e.g. the raw material ratios, they are generally referred to as the "recipe" of a drug. During drug development or process validation, these device parameters are constantly being adjusted. With versiondog, the version comparison takes place directly and therefore quickly in the software. A technician from the Smart-Manufacturing team sums up the advantage as follows: "As soon as the test product that best corresponds to the original design has been found, we use versiondog to immediately access the saved recipe to find the most suitable parameter ratios. This increases the efficiency of our research considerably."