All information contained in this document should be written in English. If the original is not in English, the original should be submitted together with English.
Every page of the document must be marked with page number and date. (month/year)
The application must be submitted in duplicate to CDER or CVM's US Food and Drug Administration. The company's American agent and manufacturer each keep one copy.
Part a: address file
1. Business address
Provide address and contact information
2. Production address
Provide address and contact information
3. Relevant agents
3. 1 national contact person
Point out the contact person and contact information in your country.
3.2 American agents
The FDA requires foreign manufacturers to appoint a document agent in the United States, and the duties of the agent must be clear. Contact information.
Contact information should include: name, country, province, city, county, street number, telephone number, fax number, e-mail address, and even the registration number of the API manufacturer. Sterile APIs should include sterile process areas.
Part B: Statement of Commitment
We promise to produce * * * products in strict accordance with the production conditions and procedures described in the document, and promise to abide by cGMP in production operation. There is nothing inconsistent with the document description, and any major changes will be reported to the authorized citation of FDA and DMF for review and approval. The document is revised once a year, and any minor changes should be shown in the revised version.
We hereby undertake to produce in strict accordance with the production conditions and procedures described in DMF and cGMP. There is no deviation in the description in this document. Any major revision will be submitted to the FDA and submitted to those who have access to the document for review and approval.
We hereby certify that under no circumstances will we accept the services of those who violate the Federal Food, Drug and Cosmetic Act 1992, Rev. 50 1(a) or (b) related to this application document.
We hereby declare that we will not accept any service that violates the Federal Food, Drug and Cosmetic Act (50 1(a) and (b)) in our application activities.
We hereby certify that the applicant and/or any person in charge related to this document. . . .
Intellectual property rights and patent commitments (no intellectual property rights and patent disputes)
As a confidential document, the application document is submitted to FAD by * * * (manufacturer's name), which should be properly kept. According to the provisions of the Freedom of Information Law, it is not necessary to disclose it publicly.
The FDA shall properly and safely keep the submitted DMF as a restricted confidential document without public disclosure.
According to the freedom of information act.
Any citation in this document supporting its pharmaceutical application shall be authorized in writing by our American agent.
Anyone must obtain the authorization of our company's agent in the United States in advance to refer to this document and understand its drug application.
Part C: Organization chart and key personnel organization chart and key personnel
1. Organization chart
Including senior managers at all levels. (Maintenance/Engineering, Production, Storage, Quality Assurance and Quality Control)
Including every senior manager at all administrative levels (involving maintenance/engineering, production, storage, quality assurance and quality control)
2. Key staff
Briefly describe the educational background (graduate school, major), qualifications and experience of the main personnel in each department.
A brief description of the academic qualifications, qualifications and experience of the main personnel of each department.
Part d: description of facilities
1. Plant layout
Point out the location of key buildings (storage, production and quality control)
Mark the location of key buildings
2. Storage equipment
The area of the building and any special structural features shall be stated. (location, number of floors, existence of special facilities, storage tank capacity, solid storage capacity, location of main materials, location of finished products)
Area and characteristics of any special building
3. Production facilities
3. 1 General information overview
The area of the building and any special structural features shall be stated.
Area and characteristics of any special building
3.2 Equipment Layout
Equipment layout
Equipment layout drawing marked with equipment number and equipment purpose.
Equipment layout and its reference number and use
3.3 Catalogue of Main Production Equipment
catalogue
The list of main production equipment includes:
List of main production equipment
EquipmentNo. Equipment Name Equipment Volume/Material Location (OperationNo.)
Example: R04 jacketed reaction tank, 3000L/stainless steel
Reference Number Name Capacity/Material Location
For example, R04 reaction tank with interlayer of 3000 liters/stainless steel.
3.4 Maintenance and calibration of factories and equipment
maintain
Explain the internal procedures for daily inspection, maintenance and calibration of workshops, production equipment and auxiliary equipment (measuring instruments, measuring tanks, etc.). ) (abstract)
Description of internal procedures for daily inspection, maintenance and calibration of production equipment and auxiliary equipment (measuring instruments, measuring tanks, etc.). )
4. Quality control laboratory
4. 1 general information overview
The area of the building and any special structural features shall be stated. (location, floor, special facilities)
Area and characteristics of any special building
4.2 Main experimental equipment
Main laboratory equipment
The list of main experimental equipment includes:
List of main laboratory equipment
Manufacturer's name/model, inspection cycle and unit quantity
Example: infrared spectrum detector Perkin Elmer/IR40
Manufacturer's name/model reference number
Infrared spectrum detector Perkin Elmer/IR40 2
4.3 Equipment Maintenance and Equipment Calibration
Explain the internal procedures for daily inspection, maintenance and calibration of major experimental equipment (summary)
Internal procedures for daily inspection, maintenance and calibration of major experimental equipment.
Section e: raw material control procedures for material control.
1. Material inventory procedure for raw material procurement
Brief description
2. Sampling, inspection and release of raw materials.
Brief description
3. Raw materials are materials for transmission and delivery.
Brief description
Part f: XXX production XXX production
1. product overview general information
1. 1 naming
The name adopted by the United States
Pharmacopoeia name
Chemical name and molecular formula, molecular weight chemical name, molecular formula, molecular weight.
Generic name: inn (international non-proprietary name), chemical name.
Enterprise name or laboratory code
CAS code (CAS) m $ NUMBER
1.2 structural formula, physical and chemical properties and physical and chemical characterization
Comprehensive description of physical and chemical properties and structures based on appropriate analytical methods. It is sufficient to use descriptions equivalent to the legal reference standards for drugs contained in the United States Pharmacopoeia and the British Pharmacopoeia.
The physical properties of the product are described in detail as whether there is polymorphism (proved by experimental data)
A comprehensive description of physical and chemical properties and structure based on appropriate analytical methods. For drugs involved in the United States Pharmacopoeia and British Pharmacopoeia, refer to the description of official standards.
The description of physical characteristics should specify whether there are polycrystals (proved by experimental data).
1.2. 1 structure
constitutional formula
structural formula
molecular weight
For protein raw materials of natural origin, it should include: amino acid sequence diagram showing glycosylation point and post-translation modification, general description of molecules (such as shape, disulfide bond and subunit composition), amino acid residue number and molecular weight.
1.2.2 chemical structure identification (comparison between pharmacopoeia standard and sample atlas)
┉ element analysis element analysis (batch)
┉ infrared spectrum (three batches)
┉ NMR spectrum (batch)
┉ UV spectrum (three batches)
┉ Mass spectrometry (batch)
To be continued …
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Fourth of July
EDMF public part (1)
European drug master document
(Name)
XXXXXX pharmaceutical factory
catalogue
1. Active ingredients ... 3
1. 1 quality standard and routine inspection ... 3
1. 1. 1 quality standard ... 3
1. 1.2 Routine inspection ... 3
1.2 scientific data ... 3
1.2. 1 Naming ... 3
1.2.2 product description ... 3
1.2.3 production method ... 3
1.2.3. 1 manufacturer and address ... 3
1.2.3.2 synthetic route (including production flow chart) 3
1.2.3.3 Brief introduction of production process ... 3
1.2.3.3. 1 process name ... 3
1.2.3.3.2 synthesis of oxygen bridge ... no! Bookmark is not defined.
1.2.5 development chemistry: ... 3
1.2.5. 1 reference substance ... 3
1.2.5.2 Potential isomer ... 3
1.2.5.3 chemical organization certificate ... 3
Infrared spectrum analysis of 1.2.5.3. 1 ... 3
1.2.5.3.2 UV absorption spectrum ... 3
65438+ NMR 3
Mass spectrometry ... 3
1.2.5.3.5 Differential thermal analysis and X-ray diffraction ... 3
1.2.5.3.6 Element analysis ... 3
Physical and chemical properties ...
1.2.6 impurities ... 3
1.2.6. 1 residual solvent ... 3
1.2.7 Batch analysis ... 3
2. Stability experimental data ... 3
2. 1 analysis method ... 3
2.2 Conclusion ... 3
2.3 Long-term experiments: ... 3
2.4 Accelerate the experiment: ... 3
2.5 experiment of influencing factors: 3
1. Active ingredient
Factory name:
Address:
Postal code:
Telephone:
Fax:
E-mail:
Home page:
Contact person:
Brief introduction of the factory:
China GMP certification certificate
1. 1 quality standard and routine inspection
1. 1. 1 quality standard
Characters:
Logo:
Optical rotation:
Related substances:
Sulfhydryl compound:
Heavy metals:
Loss on drying:
Sulfate ash:
Content:
Particle size:
1. 1.2 routine inspection
Analysis method: European Pharmacopoeia 4th edition (Ph.Eur.4).
Name ~ Version