First camp information First camp information First camp information A. Manufacturers: 1, enterprise legal person business license; 2, drug production license; 3, GMP (Good Manufacturing Practices, that is, Good Manufacturing Practice) certificate; 4, the Chinese People's **** and the State Organization Code; 5, tax registration certificate; 6, annual tax statement; 7, enterprise quality survey form; 8, quality assurance agreement. Second, the product material: 7, the product production approval (or drug registration certificate); 8, product inspection reports (the most recent provincial inspection, generally required within 2 years); 9, the product price documents (medical insurance products need to be district price); 10, product patent certificate documents (with the provision of, if not, the omission of the item); 11, trademark documents; 12, the product of each batch of inspection reports (factory inspection, the first sampling inspection when used); 13, the product Minimum box (sample); 14, a copy of the drug manual; 15, the general taxpayer certification records (with or without); 16, corporate authorization (legal power of attorney); 17, a copy of the ID card; 18, product production standards; 19, purchase and sales contracts; 20, product packaging and instructions for the approval of the internal and external 21 - purchasing and sales staff qualification certificate. Third, the pharmaceutical company's first information: 1, the business license of enterprise legal person; 2, tax registration certificate; chicken 3, the Chinese people's *** and state organization code; 4, GSP (Good Supplying Practice); 5, account opening license; 6, bank transfer account number (invoicing unit name, taxpayer identification number, address, telephone, bank account opening and account number); 7, supply units Quality Assurance System Questionnaire; 8, Quality Assurance Agreement;
Please ask the sale of drugs need to be the first pharmaceutical company's first information includes what?
The first camp includes the first enterprise and the first species.
The first enterprise: the purchase of drugs, and the enterprise for the first time the supply and demand relationship of the drug production or management enterprises. So the first enterprise information includes a smooth one, a license, a certificate, (i.e., drug production or business license, business license, GMP or GSP certificate, are stamped with a copy of the red seal) legal person authorization letter (to be signed by the legal person in person or stamped), the sales staff ID card. After agreeing to the supply and demand relationship, but also to sign: quality assurance agreement.
The first camp varieties: the enterprise to a drug manufacturer for the first time the purchase of drugs. So the first varieties of information include: a certificate, a license, a certificate, (i.e., drug production license, business license, GMP certificate, are stamped with a copy of the red seal) legal person authorization letter (to be signed by the legal person in person or stamped), the sales staff ID card. After agreeing to the supply and demand relationship, it is also necessary to sign: a quality assurance agreement. The drug production approval documents (both a copy of the approval number), a copy of the drug's quality standards, the drug test report (the red seal copy), the drug's small packages, labels, instructions (original). The final purchase of the drug with the goods with a copy of the batch number of the drug test report (stamped with a red seal).
The above is the relevant information required by the GSP certification is statutory.
Not the information required by law, but some areas also require Organization Code Certificate, a copy of the tax registration certificate, the supply unit quality system questionnaire, drug production, wholesale enterprises with the goods sales voucher style (stamped with the official seal of the enterprise and with the goods chapter), drug production, wholesale enterprises and sales staff signed a copy of the labor contract, the sales staff on the license and so on.
What is the meaning of the first camp
The first camp enterprise belongs to the category of medical devices, refers to the purchase of drugs, and the enterprise for the first time the supply and demand relationship of the pharmaceutical production or operation enterprises. The selection of the first enterprise should include qualifications and quality assurance capabilities of the audit.
What is included in the first camp information of proprietary Chinese medicine products
Consider with tennis elbow. Bone hyperplasia. Rheumatic paralysis. Labor injury. The first thing you need to do is to get a good deal on your own. The first thing you need to do is to get a good deal of money to pay for it.
The first hospital information!
33, the first enterprise and the first varieties of quality audit provisions should include what? A: the first enterprise and the first varieties of quality audit provisions should include: (1) the first enterprise and the first varieties of quality audit system should be strictly enforced, the enterprise in the signing of the first business varieties of purchase contracts, should fill out the "first enterprise and the first varieties of approval form", and accompanied by the required information. The first enterprise should also fill out the "qualified supplier file table". Approval by the person in charge of quality before the purchase of goods. (2) Quality inspection and acceptance personnel should be done after the formalities of the approval form as can be accepted or inspection into the warehouse as proof. (3) When conducting quality audit of the first enterprise and the first variety, the relevant information shall be requested from the supplier according to the provisions of GSP. (4) Drug acceptance personnel in the acceptance of the first operating varieties, should ask for the same varieties, the same specifications, the same batch number of the inspection and approval reports, and in accordance with the requirements of acceptance. (5) The quality assurance system and product situation of the first operating enterprise shall be investigated and understood. If necessary, the department in charge of quality should go to the supplier's office to conduct on-site inspection and verification to ensure the quality of drugs. (6) to do the first camp enterprise, the first camp species records, and establish files.
What materials must be available for approval of the first enterprise and the first varieties
① Obtain and review the original seal of the first enterprise stamped with the "Drug Manufacturing (Operating) License", "Business License", a copy of the quality management system certification and the original letter of authorization of the legal representative of the enterprise with the signature of the legal representative of the supplying unit or the seal of the original letter of authorization of the legal representative of the enterprise, and a copy of the identity card of the drug sales staff, Post certificate, quality assurance agreement and other information integrity, authenticity and validity. ② Audit whether the valid license is beyond the scope of production (business) and business mode. ③ operation of special management of drugs for the first enterprise, but also must audit the legal qualifications for the operation of special management of drugs, for the first enterprise stamped with the original seal of the drug supervision and management department's approval documents.
2016 requirements for the new version of gsp first business enterprises and the first varieties of audit what information
first business enterprises
business license (three certificates in one) copy
bank account opening certificate replica
copy of the drug production, business license
copy of the GMP or GSP certification
Stamp impression and accompanying counterparts of the ticket
Account name, bank and account number
Supplier's sales staff of the legal power of attorney and a copy of the identity card of the delegate (the above documents should be stamped with the company seal)
The first varieties of
Drugs with the seal of the registration of the seal
Raw material drugs to do the first camp what materials are needed?
1). Drug manufacturer information: including basic information (size, personnel, quality), production license, GMP certification;
2). Drug business enterprise information: including basic information (size, creditworthiness, etc.), GSP certification, quality assurance certificate;
3). The basic information of the authorized agent, copy of ID card, power of attorney.
The above is the information of the first drug and the first enterprise.
New gsp first camp varieties of information to what
Know what things first camp goods know how to deal with
First camp enterprise documents and detailed information on the qualifications of the drug company
First, the first camp enterprise should provide the following information (a) drug manufacturers 1, stamped with the manufacturer's original seal of the "Business License" and "Drug Production License Copy 2, stamped with the original seal of the manufacturer's GMP certification and other relevant proof of quality certification 3, stamped with the original seal of the manufacturer's trademark registration certificate copy 4, stamped with the original seal of the manufacturer, the corporate representative of the legal representative of the signature of the legal person power of attorney, and indicate the scope of the commission authorization and the period of validity of the 5, a copy of the identity card of the sales staff 6, quality assurance agreement or quality commitment 7, the quality of enterprises, the honorary certificates obtained (two) (B) pharmaceutical companies 1, stamped with the original seal of the operating business enterprises, "business license" and "drug license" copy 2, stamped with the original seal of the operating business enterprise GSP certification and other relevant proof of enterprise quality certification 3, stamped with the original seal of the operating business enterprise, the enterprise's legal representative signed by the legal representative of the legal person letter of attorney with the scope of delegation of authorization and the period of validity of the commission 4, the sales staff of the A copy of the ID card 5, the amount of guarantee agreement or quality commitment 6, the quality of the industry to obtain certificates of honor, etc. Second, the first varieties should be provided with the following information: (the manufacturer to goods) 1, stamped with the original seal of the manufacturer of the production of a copy of the approval number 2, stamped with the original seal of the manufacturer of the drug quality standards (national standards) copy 3, stamped with the original seal of the manufacturer or its quality institutions qualified drug test report (single) 4, stamped with the original seal of the manufacturer or its quality institutions qualified drug test report (single) copy. A copy of the report (single) 4, in the trade name of the first varieties, should be provided with the original seal of the production unit of the relevant documents, the trade name registered as a trademark, should also provide a copy of the corresponding certificate of registration of trademarks 5, stamped with the original seal of the producer of the price of a copy of the authorization 6, belonging to the new drugs, traditional Chinese medicine varieties of medicines under protection, should be provided with a stamped with the original seal of the producer of the certificate of the new drugs, traditional Chinese medicines varieties of certificates, such as the protection of the certificate Copy 7, stamped with the original seal of the manufacturer of the drug packaging, labeling and instructions of the approval and the actual sample 8, to provide physical samples of drugs