GMP and DML, What Are They?
Speaking of the sequence to get GMP and DML, we cannot avoid explaining the Drug Approval Document Number.
Let me explain the three one by one.
The Drug Production License is a prerequisite for a pharmaceutical company to produce drugs.
If the manufacturer does not obtain this certificate, then the subsequent work cannot be carried out at all such as applying for a Drug Approval Number, and GMP certification.
After obtaining the Drug Manufacturing License, the manufacturer can apply for the Drug Approval Document Number.
The Drug Approval Document Number is legal proof of a drug.
This is where a drug and a chemical differ.
The importance of this document is to indicate that the applicant applied in strict accordance with the drug R&D process.
To sell the chemical as a drug, this Number is a must.
The API manufacturer must prove to SFDA that their drug is safe, effective, and quality controllable.
SFDA will not issue the Drug Approval Document Number until the manufacturer can meet those three requirements.
After obtaining the Drug Approval Document Number, the drug is still not available for sale.
Because there is no guarantee that your large-scale production process will follow the legal procedures.
So what is this legal procedure?
That is where GMP (Good Manufacturing Practice) comes in.
All the manufacturing conditions for the drug must be carried out by GMP requirements.
After the manufacturing conditions pass the SFDA certification, State FDA will issue a GMP certificate to the manufacturer.
Only at this point can the manufacturer sell the APIs as drugs.
Therefore, the manufacturer gets the Drug Manufacturing License, the Drug Approval Document Number, and the GMP Certificate by this sequence one by one.
With the Drug Manufacturing License, the manufacturer has the permit to produce drugs, while they can make clinical samples but cannot sell them as drugs.
It means that the manufacturer has production conditions meeting the requirements.
This is a pre-licensed drug project so that they can make clinical samples to get the Drug Approval Document Number.
The manufacturer can apply for GMP certification after obtaining the Drug Approval Document Number, and the manufacturer can not sell the API until they have the GMP certificate.
All in all, the manufacturer can not sell the drug until they get all three certificates.
Differences Between GMP and DML
China GMP Copy
China Drug Manufacturing License Copy
1. Meanings
Drug manufacturers obtain the GMP through certification from authorities according to the law.
Pharmaceutical GMP certification is a system in which The State FDA conducts GMP supervision and inspection of pharmaceutical manufacturing workshops and pharmaceutical products.
The Drug Manufacturing License is a production permit issued by the Local FDA.
Without this permit, the drug manufacturer can not produce drugs.
2. The Content
GMP is a set of compulsory standards applicable to pharmaceutical industries.
The GMP certificate states that the drug manufacturer has met sanitary quality requirements by relevant national regulations in terms of raw materials, personnel, facilities and equipment, production processes, packaging and transportation, and quality control.
The Drug Manufacturing License is a permit for the manufacturer to produce drugs.
It shows such items as the license number, the name of the drug manufacturer, the legal representative, the person in charge of the enterprise, the type of enterprise, the registered address, the production address, the scope of production, the issuing authority, the date of issue, and the validity.
3. The Responsible Authority
GMP is certified at 2 levels, at first by the provincial FDA, and later by State FDA.
The Drug Regulatory Department of the State Council is responsible for the GMP certificate.
The Drug Manufacturing License should be reviewed and decided upon by the drug regulatory department of the province, autonomous region, and municipality (food) where the enterprise is located.
Any customer interested in receiving GMP and DML certificates, please leave your email so we can send you copies for your comparison.
Anyone who shares different opinions is welcome to comment below so we can discuss them together!