(Released December 13, 2002 the State Drug Administration, 36th) Chapter I General provisions article in order to strengthen the control of biological products, ensuring biological products is safe and effective, according to the People's Republic of China pharmaceutical administration law and the People's Republic of China pharmaceutical administration law implementing regulations, these measures are formulated.
The second lot release of biological products (hereinafter lot release) refers to vaccine products, blood products, blood screening in vitro biological diagnostic reagents and other biological products as prescribed by the State Drug Administration, each batch of products manufactured before sale or import a mandatory review, inspection and approval system.
Pursuant to these measures provided for lot release of biological products has not been issued shall not be sold or imported, and prohibited from use.
Third State food and Drug Administration has authorized it sets inspection agencies or designated by lot release of biological products.
Fourth subject to lot release management of biological products for determined and published by the State Drug Administration.
Lot release of biological products standard for existing national biological products for review, examination procedures and other standards approved by the State food and drug administration.
Chapter II application section fifth manufacturer complete bio-production, inspection, fill in the application form for lot release of biological products, to undertake batch issued by the inspection body for lot release.
Sixth application for lot release of biological products must have one of the following drug approval documents: (a) the approval number.
(B) the imported drugs registration certificate or the certificate of pharmaceutical product registration.
(C) the in vitro biologic diagnostic reagent approved certificates of registration.
Article seventh batch issued by the technical requirements and information formats, developed by pharmaceutical and biological products, China.
Section eighth for lot release and samples will be required to submit the following information: (a) the application form for lot release of biological products.
(B) the head of quality assurance in pharmaceutical production enterprises signed and sealed by the Department of manufacturing and inspection record summary.
(C) examination of samples required.
(D) other information associated with the product quality.
(E) the producer of imported biological products should be submitted simultaneously to the lot release certificate issued by national drug regulatory authorities, and to produce a Chinese translation.
Chapter III reviews, test laboratories and article Nineth batch issued by institutions should be equipped with compatible with the issuance of personnel and equipment, quality assurance system according to biological products review, inspection, and technical requirements. Article tenth lot release information or information and sample testing of double combination.
Sample inspection into all project inspection and inspection of part of the project.
Lot release of specific varieties used and examination of projects organized by Chinese drugs and biological products evaluation and approval of the State Drug Administration.
11th the review include: (a) the application materials are complete; product batch manufacturing and test summary is sealed by the quality assurance Department and authorized signature.
(B) production, such as bacteria and viruses, cells are consistent with the approval of the State Drug Administration.
(C) production is consistent with the State food and Drug Administration approval process; whether the quality control of the production process to achieve the requirement of national drug standards.
(D) the bulk of products, semi-finished products and finished products inspection, methods and results in line with the provisions of the national drug standards.
(E) the packaging, labelling and instructions are in conformity with the relevant provisions. Article 12th batch issued by the inspection bodies can be tailored to specific review of the need to increase the inspection project.
Increased inspection items and reasons shall be reported to the national drug administration records.
Article 13th batch of drug inspection bodies shall issue in the work under way to complete the work within the time limits, issued to the application issued by the manufacturer and lot release documentation.
14th batch issuance time requirements: vaccine-55.
Blood products: 30th.
Blood source screening reagents class: 15th.
Other categories: provisions according to the product test cycle.
Cannot be made within the time limit provided for in article 15th batch issuing conclusions, assume batch issued by the drug testing agency should be the reason for extension and time reported that the State food and Drug Administration for the record and issue the applicant written notification batches. 16th section to check the relevant data needed in the application, bear the lot release of drug inspection Office shall upon receipt of the application within the 10th issued the applicant written notification batches at once.
Applicants should check the results 5th days after receiving the notice and its original reply assume batch issued by the inspection bodies.
Article 17th batch issued by the inspection bodies based on the review of the need, sent to the applicant on-site verification or sample.
Article 18th Biologics lot release certificate issued by the bear's drug control agency chief or by a person authorized to issue, in line with the requirements of, the Biologics lot release certificate was issued.
Article 19th belongs to one of the following circumstances, issued by a drug testing take on lot release lot release of biological products notice of nonconformity, unqualified and indicate the following items: (a) declare the information does not meet the requirements of.
(B) failed to pass the quality test.
(C) applicants not complying with the provisions of the present article 16th reply or reply information still does not meet the requirements of.
20th article biological products batch issued certificate and biological products batch issued not qualified notice by bear batch issued of drug test institutions according to order number, its format for "batch signed x check xxxxxxxx", which, Qian x symbol representative authorized batch issued of drug test institutions where provincial administrative or institutions of referred to; Hou 8 a x symbol of Qian 4 bit for public first year,, Hou 4 bit for years order,.
Article 21st when the sales lot release of biological products, stamped with the seal of the batch of biological products must be provided copies of the Biologics lot release certificate.
Section 22nd issued unqualified banned the sale of biological products, by the manufacturer in accordance with the relevant provisions of good manufacturing practice shall be destroyed, destruction of records should be submitted to the provincial drug administration, drug testing and implementation of lot release record. Fourth chapter review article 23rd drug manufacturers of biological products notice of not objection, from the date of receipt of the notification in the 7th. Liable to the original lot release for drug testing agency or apply for technical review of pharmaceutical and biological products.
Needs verification, whose sample for drug testing take on lot release to retain samples.
Article 24th issue of drug control organizations receive technical review of an application submitted by the drug manufacturer, should be on projects of its complaints review or inspection, issued upon completion of the review to the complaints unit within the 5th review comments.
Chapter fifth penalty 25th pharmaceutical producing enterprises to provide false information or samples, in accordance with the People's Republic of China of 83rd of the drug administration law shall be punished.
Article 26th sale should be issued without obtaining biological products of the Biologics lot release certificate, in accordance with the People's Republic of China of 48th of the drug administration law shall be punished.
27th of forgery of the Biologics lot release certificate, in accordance with the People's Republic of China Law 82nd of the drug administration law shall be punished.
28th article of issuing false inspection reports issued by the drug testing agency, in accordance with the People's Republic of China Law 87th of the pharmaceutical administration law shall be punished.
Sixth chapter supplementary articles article 29th of biological products in manufacturing and inspection record abstracts, refers to each batch of biological products from raw materials to packaging of the whole production process correctness and affect the quality of biological products and results in the inspection points and the results of operations and audit by the quality assurance Department. Article 30th for short and long test period the validity of lot release of biological products, pharmaceutical production enterprises in production to assume batch issued by the inspection body for lot release.
Undertake batch of drug inspection bodies shall issue in drug manufacturers pay on inspection records and other information in accordance with the regulations to be issued.
Issued by the 31st batch with one of the following varieties of biological products, approved by the State food and drug administration allows batch issued: (a) for the control of outbreaks or emergency requiring urgent use of the products.
(B) the United Nations Children's Fund and other international organizations to donate or vaccine products.
32nd article this way the working hours in the day to day.
Article 33rd application issued by the manufacturer must be paid in accordance with the relevant provisions of the relevant expenses.
34th article of the rules come into effect on January 15, 2003. 附件一、
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生物制品批签发申请表
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│ 记录摘要〔 〕 全套制检记录〔 〕 │
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│企业负责人（或授权人）签字： │企业公章： │
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│ │ └-The-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the ┘ note: has select of items please in "()" within designated "√" (each Zhang application table only fill in a batch of content) =tbl/> annex II: = biological products batch issued certificate Certificate for the Rel Ease of endorsed checked XXXXXXXX x-Certificate No Biological Products: product name _______________________________________________ ___________________
Name of the product
生产单位__________________________________________________________________
Manufacture
地址________________________________________________
______________________ Address batch number ____________ __________ __________ forms specification is valid until __________ ________ Lot No Dosage Form Strength Valid until Quantity in bulk, upon examination, the product mentioned above complies with relevant provisions issued by the State, admission to the factory.
The product mentioned above complies with the concerned provisions and has been approved for release.
This certification is based on the enterprise reporting product manufacturing and inspection summary issued review of ____________.
This certificate is based on examination of summary manufacturing protocol.
签发人：
Issued by
签发单位及公章
年 月 日
=tbl/>
附件三：
= Lot release of biological products notice of not Notice of Not Release of Biological Products endorsed checked XXXXXXXX x No
：
制品名称__________________________________________________________________
Name of the product
生产单位__________________________________________________________________ __________________________________________________________________ Address batch number ____________ __________ __________ forms specifications Manufacturer address valid until __________ ________ bulk Lot No Dosage Form
Strength Valid until Quantity after reviewing the product mentioned above does not meet the relevant provisions issued by the State, no to the factory.
The product mentioned above does not comply with the concerned provisions on examination of summary manufacturing protocol and is not approved for release.
______________________________________________________________ Unqualified items The item (s) of out of specification is (are) the issuer:
Issued by
签发单位及公章
年 月 日
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