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DMF and FDA for pharmaceutical manufacturer

Jason Dec 12,2018 Share this post:

According to the Code of Federal Regulation,if your drug want to enter into USA,you must apply for registration with American FDA and submit related information to FDA.You need submit the Drug Master File(DMF) as required.

The DMF is a document,it is detail produced process information of certain drug in pharmaceutical factory.The DMF is easy to comprehensive understand the drug for FDA.The DMF should contain the information,the workshop equipments and material of produce,process,package and store,which can ensure that the GMP of drug producing is guaranteed.

The DMF documents have five types,

Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel

Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product

Type III: Packaging Material

Type IV: Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation

Type V: FDA Accepted Reference Information

The manufacturers of bulk drug supply for DMF to FDA,this DMF documents belong to type II,the application documents contain:application documents,related administrative information,corporate commitment statement,description of the physical and chemical properties of the applied product,product production method details,product quality control and production process control,product stability test,packaging and labeling,standard operating procedure,storage and management of raw materials and finished products,document management,verification,batch number management system,return and handling.

The FDA will first review the original copy DMF documents which is supplied,when this document has received.If the drug conforms to essential requirements of relevant provision,The FDA department will send notice and issue a DMF number to the medicine manufacturer.

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