Production Capacity and Quality Control
We always make detailed production plan depending on the customers ‘ demanding .
Next is our normal production plan every month .
Hot-selling products: ND, EQ, OXY, STAN, METH etc, Our fixed production capacity is 120kg/month.TRAC, TREN, OX, DP etc, Our monthly fixed production capacity is 40-60kg/month.Conventional products: MST,MD,ME,4-CL etc. Our fixed production capacity is 6-12kg/month Firstly, We will give priority to ensure the domestic and foreign customers order production and timely delivery. For some small quantity demanded unconventional products, We will also arrange production engineer to specially produce raw materials in our lab for meeting our clients various demands. In addition, The sales department will submit marketing plan to workshop according to the actual sales situation. The head of the production workshop department will authorize extra 10-20% of the sales plan to incorporate into production plan, for ensuring that we can have greater supply capacity to meet clients’ purchasing demand.
The production process and quality management system
We are really manufacturer of raw steroid powder in China. We will test every batch when we produce it . Because we produce it ourselves ,won’t purchase it from other suppliers , we can control the purity better ,and promise every batch is over 98% purity .
OK-BIOTECH Pharma continuously improves the quality management through the implement of a complete, advanced, scientific quality management system according to USP, national and international standards.
—Analytical Method Development & Validation
—Impurity Identification and Profiling
Analytics / In Process Control
The role of the analytical department in OK-BIOTECH Pharma’s business is rapidly gaining importance. This mainly to fulfill the demands in the strictly controlled production of Pharmaceutical, Intermediates and APIs.
To ensure the quality and determine the impurity profiles of products, intermediates and starting materials mostly chromatographic (HPLC, GC, TLC, Capillary Electrophoresis) or titrimetric methods are utilized.
Analytical methods are often transferred from the customer and validated according to internationally accepted guidelines. If no validated methods are available, OK-BIOTECH Pharma develops the necessary methods and transfers them from the development to QC labs at plants. Accompanying this development is often the identification and synthesis of all important impurities for their usage as standards.
We have experienced analysts for methods development, validation and analysis. All compounds, from raw materials to intermediate to final products, are analyzed in the QC department of OK-BIOTECH Pharma. Further support during the development and optimization phases of a project comes from the wide variety of different analytical methods which are available on our R&D center.
Our company has the most domestic advanced production line. Part of the core production machines (reactor) are imported from Germany and regularly passed through strict inspection and cleaning in order to ensure the production line can be very efficient operated. The production department operators will receive rigorous training before taking up their positions, And some employees have more than three years operating experience. The chief engineer who is in charge of the workshop will be responsible for the whole production process which including raw material inspection, feeding, stirring, dilution crystallization, baking etc. Our chief engineer has ten years of experience in the production of steroid powder, and also are familiar with the production technology and production process .