Home> News>Company News

Calcichew D project finishes process certification

作者:海默尼药业有限公司时间:2018-12-13

Recently, production of three process certificate batches of Calcichew D (Calcium carbonate (CaCO3) D3 chewable tablet) project of Hemony has been completed smoothly. It is a milestone for stage winning since the project was started in June 2017.

16110715346240.jpg

As a leader in calcium supplement, Calcichew D3 has the advantages such as fast and uniform dissolution and good taste. It is the first choice for calcium supplement for children, the aged, pregnant and lactating women.

For smooth transfer of the project, Hemony sets up a Calcichew Technology Transfer Project Team, which gradually transfers the project according to the EU's high standards and strict requirements. Through preliminary investigation, technical disclosure, equipment procurement and stage work of purified water and A/C system verification, the production line C has been installed and verified in October 2018.

The production line C has been constructed in accordance with the company's strategic requirements. First class equipment has been selected to guarantee product quality with the attitude of being solid and reliable. To ensure project progress, the project team regularly has compared the progress with the benchmark, verified problems existing in the transfer process and provides professional and compliant technical guidance. Meanwhile, management personnel and operators have been dispatched to Shanghai for technical study and exchange to ensure smooth transfer of products.

Although the process verification batch of Calcichew D project is completed, the project team does not take it easy. Next, it will transfer to comparative study of product quality, stability test of product, registration of process technology transfer, collection, collation and summary of technical date to prepare for on-site verification, GMP certification and CGMP certification of 2019.

Through the Calcichew D project, the research and development team of Hemony has accumulated rich experiences and laid a good foundation for technology transfer and handover of similar projects in the future.