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Product Description

Raw material procurement agent
Section of supplier selection and basic requirements
First, the principle of selection
1. Quality priority principle
2, relatively fixed principle
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3. Mutual promotion and win-win principle
Second, the basic requirements

1. Complete qualifications. The corresponding supplier or material must have the following qualification certificate and is valid.
Supplier category China sourcing agent for API Qualification documents
Pharmaceutical manufacturer
Business license
Pharmaceutical production license
Drug registration approval or drug re-registration approval
Pharmaceutical GMP certificate (API, Chinese Herbal Pieces)
Direct contact with drug packs
Material manufacturing company
Business license
Drug packaging materials and container registration certificate
Quality standard
Manufacturer inspection report
Outer packaging material manufacturer
Business license
Printing business license (required for print companies)
Product barcode printing qualification certificate (not required)
Medical equipment agent procurement
manufacturer
Business license
Medical device manufacturing enterprise record
Medical device registration certificate and medical device registration form
Quality standard
Manufacturer inspection report
Pharmaceutical business
Business license

chinese leading Sourcing Agent for API


Pharmaceutical business license
Drug GSP certificate
Approval documents for the approval of pharmaceutical GMP certificates and drug registration approvals for the corresponding production enterprises
With the purchase and sale agreement with the manufacturer or upstream supplier, if the imported raw materials are supplied, the following information is required.

[Import Drug Registration Certificate" or [Pharmaceutical Product Registration Certificate" or [Imported Drug Approval Form" and [Imported Medicine Approval Form"

[Imported" and stamped with the [Imported Drugs Customs Clearance Form" or the [Drug Inspection Report" issued by the Port Drug Inspection Institute

Other companies
Business license
Production license or business license
Health permit
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2, management practices
Chinese Sourcing agent for API
In addition to the above qualifications, suppliers should also have a certain scale of operation and management level, a sound quality management system, various production and business activities in line with the requirements of government and laws at all levels, good reputation, stable and lasting. Supply materials. See the table below for specific requirements.

Supplier category
Laws and regulations

Pharmaceutical manufacturer
"Good Manufacturing Practices"

Direct contact with drug packs

Material manufacturing company
Measures for the Administration of Packaging Materials and Containers Directly in Contact with Medicines

Outer packaging material manufacturer
"Printing Industry Management Regulations", "Drug Instructions and Label Management Regulations" (Order No. 24), "Hubei Province Commodity Barcode Management Measures"

Medical device manufacturer
Regulations on the Supervision and Administration of Medical Devices and the Measures for the Supervision and Administration of Medical Devices
Pharmaceutical business
"Pharmaceutical Management Quality Management Regulations"

Other companies
"Administrative Security Law of the People's Republic of China"
Section 2 Supplier Review Process

China sourcing agent which outsourcing and providing efficient sourcing service in china for API


First, the company's material classification

According to the amount of drug materials, the impact on the quality and safety of drugs, the materials are divided into three grades: A, B and C.

A material with a large amount of A, which has a significant impact on the quality and safety of the drug, such as pharmaceutical composition (API, main excipient), original medicinal material, process aid that directly affects the quality of the drug, and packaging material that directly contacts the drug (PVC) , aluminum foil, medicinal bottles, medicinal plastic tubes, etc.).

B-grade materials that have a large amount of consumption and have a very limited effect on drug quality and safe use of drugs, such as general excipients, boiler salts, heat shrinkable films, etc.; printed materials that are not directly in contact with pharmaceuticals (labels, boxes, instructions) , large boxes with printed characters, etc.; including reagents, culture media, etc. Although there is no direct impact on the quality of the drug, it has an important impact on the evaluation of product quality.

Class C Materials that have little effect on the quality of the drug, such as office supplies, shoe covers, hand sanitizers, disinfectants, etc.
Second, the new supplier review process

Note: If you need to file with the relevant regulatory authorities, you can become a qualified supplier after filing for approval.
Third, the supplier on-site audit process
Section III Assessment of Suppliers
First, incentive
1. The company conducts assessments on suppliers every quarter and adjusts the supply of suppliers according to the assessment results. The one with the best performance is the main supplier, and the supply is increased. The other qualified applicants are the sub-suppliers, and the supply is reduced.
2. The company invites suppliers with excellent annual evaluation to participate in the next year's bidding.
Second, the constraints
1. Suppliers provide multiple inspections of materials. Non-conforming products have many common quality problems during storage and use. The product* has an abnormal condition and cannot be delivered smoothly as normal. The company issued a warning to it, the supplier should carry out corresponding rectification, and feedback the investigation results and handling opinions to the company;

2. The supplier suspends the purchase and compensates for the corresponding losses of the company in any of the following cases, and retains its supplier qualifications and files. The time of suspension depends on the supplier's rectification and cooperation.

A. The material has serious quality problems during the inspection and storage process, and the supplier is required to conduct investigation and rectification;

B. After receiving the warning feedback letter, the supplier cannot improve in time and similar problems occur again in the next batch of supply;

C. Insufficient cooperation with the company, in order to inform the company in advance to adjust the material process or change standards and adversely affect the quality of the company's products.
Chapter III Information for Suppliers

First, the basic requirements for the material packaging
1. Firmly able to meet the in-transit transportation and turnover requirements of the goods;
2, the outer packaging of cleaning materials should be clean and free from pollution and damage;
3, sealed raw materials and pharmaceutical packaging materials should be sealed, can effectively avoid pollution, cross-contamination and confusion.
Second, the requirements for the labeling of materials packaging
At least the following information should be indicated on the outer packaging of the following material categories.
1. Raw materials: product name, specification, batch number, production date, expiration date, approval number, implementation standard, single package quantity (net weight/gross weight), manufacturer name.

2, Chinese herbal medicines: product name, specifications, quantity, origin, source, harvest (primary processing) date.

Chinese Herbal Pieces: Name, Specification, Origin, Manufacturer, Product Lot, Date of Production.

3. Inner packaging materials/medical devices/hygiene products: product name, specification, batch number, production date, drug registration certificate number/medical device registration certificate number/hygiene license number, implementation standard, and manufacturer name.

4. Printing and packaging materials: product name, specification, batch number, production date, and name of the manufacturing company.

Third, the quality assurance agreement

According to the new GMP regulations of the State Food and Drug Administration: Our company should sign a quality agreement with the material supplier, and the quality responsibility of both parties should be clarified in the agreement.
Raw material procurement agent

Section of supplier selection and basic requirements

First, the principle of selection


1. Quality priority principle

2, relatively fixed principle

3. Mutual promotion and win-win principle

Second, the basic requirements

1. Complete qualifications. The corresponding supplier or material must have the following qualification certificate and is valid.

Supplier category
Qualification documents

Pharmaceutical manufacturer
Business license

Pharmaceutical production license

Drug registration approval or drug re-registration approval

Pharmaceutical GMP certificate (API, Chinese Herbal Pieces)

Direct contact with drug packs

Material manufacturing company

Business license

Drug packaging materials and container registration certificate


Quality standard

Manufacturer inspection report

Outer packaging material manufacturer
Business license

Printing business license (required for print companies)
Product barcode printing qualification certificate (not required)

Medical equipment agent procurement

manufacturer
Business license

Medical device manufacturing enterprise record

Medical device registration certificate and medical device registration form

Quality standard

Manufacturer inspection report

Pharmaceutical business
Business license

Pharmaceutical business license

Drug GSP certificate

Approval documents for the approval of pharmaceutical GMP certificates and drug registration approvals for the corresponding production enterprises

With the purchase and sale agreement with the manufacturer or upstream supplier, if the imported raw materials are supplied, the following information is required.

[Import Drug Registration Certificate" or [Pharmaceutical Product Registration Certificate" or [Imported Drug Approval Form" and [Imported Medicine Approval Form"

[Imported" and stamped with the [Imported Drugs Customs Clearance Form" or the [Drug Inspection Report" issued by the Port Drug Inspection Institute

Other companies
Business license
Production license or business license

Health permit

2, management practices

In addition to the above qualifications, suppliers should also have a certain scale of operation and management level, a sound quality management system, various production and business activities in line with the requirements of government and laws at all levels, good reputation, stable and lasting. Supply materials. See the table below for specific requirements.

Supplier category
Laws and regulations

Pharmaceutical manufacturer
"Good Manufacturing Practices"

Direct contact with drug packs

Material manufacturing company
Measures for the Administration of Packaging Materials and Containers Directly in Contact with Medicines

Outer packaging material manufacturer
"Printing Industry Management Regulations", "Drug Instructions and Label Management Regulations" (Order No. 24), "Hubei Province Commodity Barcode Management Measures"

Medical device manufacturer
Regulations on the Supervision and Administration of Medical Devices and the Measures for the Supervision and Administration of Medical Devices



Pharmaceutical business
"Pharmaceutical Management Quality Management Regulations"

Other companies
"Administrative Security Law of the People's Republic of China"


Section 2 Supplier Review Process

First, the company's material classification

According to the amount of drug materials, the impact on the quality and safety of drugs, the materials are divided into three grades: A, B and C.

A material with a large amount of A, which has a significant impact on the quality and safety of the drug, such as pharmaceutical composition (API, main excipient), original medicinal material, process aid that directly affects the quality of the drug, and packaging material that directly contacts the drug (PVC) , aluminum foil, medicinal bottles, medicinal plastic tubes, etc.).

B-grade materials that have a large amount of consumption and have a very limited effect on drug quality and safe use of drugs, such as general excipients, boiler salts, heat shrinkable films, etc.; printed materials that are not directly in contact with pharmaceuticals (labels, boxes, instructions) , large boxes with printed characters, etc.; including reagents, culture media, etc. Although there is no direct impact on the quality of the drug, it has an important impact on the evaluation of product quality.

Class C Materials that have little effect on the quality of the drug, such as office supplies, shoe covers, hand sanitizers, disinfectants, etc.

Second, the new supplier review process

Note: If you need to file with the relevant regulatory authorities, you can become a qualified supplier after filing for approval.
Third, the supplier on-site audit process
Section III Assessment of Suppliers
First, incentive
1. The company conducts assessments on suppliers every quarter and adjusts the supply of suppliers according to the assessment results. The one with the best performance is the main supplier, and the supply is increased. The other qualified applicants are the sub-suppliers, and the supply is reduced.
2. The company invites suppliers with excellent annual evaluation to participate in the next year's bidding.
Second, the constraints
1. Suppliers provide multiple inspections of materials. Non-conforming products have many common quality problems during storage and use. The product* has an abnormal condition and cannot be delivered smoothly as normal. The company issued a warning to it, the supplier should carry out corresponding rectification, and feedback the investigation results and handling opinions to the company;
2. The supplier suspends the purchase and compensates for the corresponding losses of the company in any of the following cases, and retains its supplier qualifications and files. The time of suspension depends on the supplier's rectification and cooperation.
A. The material has serious quality problems during the inspection and storage process, and the supplier is required to conduct investigation and rectification;
B. After receiving the warning feedback letter, the supplier cannot improve in time and similar problems occur again in the next batch of supply;
C. Insufficient cooperation with the company, in order to inform the company in advance to adjust the material process or change standards and adversely affect the quality of the company's products.
Chapter III Information for Suppliers
First, the basic requirements for the material packaging
1. Firmly able to meet the in-transit transportation and turnover requirements of the goods;
2, the outer packaging of cleaning materials should be clean and free from pollution and damage;
3, sealed raw materials and pharmaceutical packaging materials should be sealed, can effectively avoid pollution, cross-contamination and confusion.
Second, the requirements for the labeling of materials packaging
At least the following information should be indicated on the outer packaging of the following material categories.
1. Raw materials: product name, specification, batch number, production date, expiration date, approval number, implementation standard, single package quantity (net weight/gross weight), manufacturer name.

2, Chinese herbal medicines: product name, specifications, quantity, origin, source, harvest (primary processing) date.

Chinese Herbal Pieces: Name, Specification, Origin, Manufacturer, Product Lot, Date of Production.

3. Inner packaging materials/medical devices/hygiene products: product name, specification, batch number, production date, drug registration certificate number/medical device registration certificate number/hygiene license number, implementation standard, and manufacturer name.

4. Printing and packaging materials: product name, specification, batch number, production date, and name of the manufacturing company.

Third, the quality assurance agreement
profisional sourcing agent for API Sourcing
According to the new GMP regulations of the State Food and Drug Administration: Our company should sign a quality agreement with the material supplier, and the quality responsibility of both parties should be clarified in the agreement.

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