GMP and DML, What Are They?
Regarding the sequence for obtaining 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 producing drugs for a pharmaceutical company.
If the manufacturer does not obtain this certificate, subsequent work, such as applying for a Drug Approval Document Number and GMP certification, cannot be carried out.
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 an API, and that is where a drug substance and a chemical differ.
This document is essential because it indicates 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.
There is no guarantee that your large-scale production process will follow legal procedures, but what are these legal procedures anyway?
That is where GMP (Good Manufacturing Practice) comes in.GMP requirements specify all manufacturing conditions for drugs.
After the manufacturing conditions pass the SFDA certification, the State FDA will issue the manufacturer a GMP certificate.
Only at this point can the manufacturer sell the APIs as drugs.
Therefore, the manufacturer receives the Drug Manufacturing License, the Drug Approval Document Number, and the GMP Certificate in this sequence.
With the Drug Manufacturing License, the manufacturer has the permit to produce drugs. They can also make clinical samples, but they cannot sell them as drugs.
It means that the manufacturer’s production conditions meet the requirements.
This pre-licensed drug project allows them to produce clinical samples to obtain the Drug Approval Document Number.
The manufacturer can apply for GMP certification after obtaining the Drug Approval Document Number, but it can not sell the API until it has the GMP certificate.
All in all, the manufacturer cannot sell the drug until it has all three certificates.
Differences Between GMP and DML
1. Meanings
Drug manufacturers obtain GMP certification through certification from authorities according to the law.
Pharmaceutical GMP certification is a system in which the State FDA (https://www.nmpa.gov.cn/) conducts GMP supervision and inspection of pharmaceutical manufacturing workshops and 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 and quality requirements set by relevant national regulations for 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 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 two levels, first by the provincial FDA and later by the State FDA.
The Drug Regulatory Department of the State Council is responsible for the GMP certificate.
The Drug Manufacturing License should be reviewed and approved by the drug regulatory department of the province, autonomous region, or municipality (food) where the enterprise is located.
If you are a 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!
