Administrative Measures On The Packaging Material And Vessels Direct Contacted With Drugs

Original Language Title: 直接接触药品的包装材料和容器管理办法

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(On July 20, 2004 national food drug supervision authority makes 13th, announced since announced of day up purposes) first chapter General first article for strengthening directly contact drug of packaging material and container (following referred to "drug package material") of supervision management, guarantee drug package material quality, according to People's Republic of China drug management method (following referred to drug management method) and the People's Republic of China drug management method implementation Ordinance, developed this approach. Article production, importation and use of drug packaging materials, must comply with the national standard of drug packaging materials.     Drug packaging materials standards formulated and promulgated by the State food and drug administration.     Third State food and Drug Administration to develop registration kits products catalog and registration of products in the catalog.     Does not ensure the quality of medicines and medicinal packaging material, State food and drug administration released out of drug packaging materials catalog. Fourth State encourages drug research, production and use of new packaging materials.     New drug packaging materials in accordance with this Regulation shall be applied for registration, approval to manufacture, import and use.     Chapter II standard fifth drug of drug packaging materials packaging materials standards, refers to the country in order to ensure drug packaging materials quality, ensure quality control of drug packaging materials and the quality of the indicators, test methods and other technical requirements.     Sixth medicine package national standards national pharmacopoeia Committee organized by the State food and Drug Administration formulation and revision and promulgation by the State food and drug administration.     Seventh, the State food and Drug Administration established or medicinal packaging material testing agency drug packaging materials to the national standard preparation and amendment of draft review, method validation, laboratory work.     Eighth national pharmacopoeia Committee requested by the State food and drug administration, drug packaging materials standards organization expert validation.     Section I of chapter III registration of drug packaging materials require the Nineth and medicinal packaging material registration includes production applications, import applications and supplemental applications. Production application refers to applications for registration of drug packaging materials produced within China.     Applicants must be legally registered in China and medicinal packaging material manufacturers. Import application, refers to the overseas production of applications for registration of pharmaceutical packaging in China market.     Overseas applicants should be legally registered abroad and medicinal packaging material manufacturers, imports to apply for registration should be made by its China offices within China or its authorized agency.     Supplementary application, refers to the production and import applications after they have been approved, changes, additions or cancel the original items or contents of the application for registration.     Tenth State and provinces, autonomous regions and municipalities directly under the food and Drug Administration (food) administrative organ of the pharmaceutical supervisory and administrative departments shall, in websites and drug packaging materials required for registration of registered establishments charge of publicity material conditions, procedures, deadlines, need to submit a list of all materials and application model. Section 11th drug packaging materials registered the information submitted must be complete, standard, true and reliable data.     The applicant should be responsible for the authenticity of its information content.     12th article national food drug supervision authority and province, and autonomous regions, and municipalities (food) drug supervision management sector on applicants proposed of drug package material registered application, should according to following situation respectively made processing: (a) application matters law not need submitted registered approval of, should rates told applicants not accepted; (ii) application matters law not belongs to accepted organ terms range of, should rates made not accepted of decided, and told applicants to other right to organ proposed application;     (Three) application material exists can spot corrections of errors of, should allows application people spot corrections; (four) application material not complete or not meet statutory form of, should in 5th within once told applicants need correction of all content, late not told of, since received application material of day up that for accepted; (five) application material complete, and meet statutory form, or applicants according to requirements submitted all correction application material of, should accepted application.     The 13th State and provinces, autonomous regions and municipalities directly under the food and Drug Administration (food) drug regulatory agency to accept or not to accept drug packaging materials applications for registration, special seal for certificate with a drug packaging materials should be accepted and indicate the date of the notice. 14th explosive package material registration review require the applicant to provide supplementary information, the State food and Drug Administration should be a one-time additional information notice issued.     Applicants shall be completed in accordance with the notice requirements in 4 months once additional information fails to refund of the additional information within the prescribed time limit.     15th and medicinal packaging material after registration and approval decision, the State food and Drug Administration should be since the date of the decision in the 10th issue, served on the decision.     State food and Drug Administration refuse to register the written decisions of the law, it shall explain the reasons and inform the applicant to apply for reexamination, the rights of administrative reconsideration or bring an administrative suit. 16th State and provinces, autonomous regions and municipalities directly under the food and Drug Administration (food) drug supervision and management departments of medicine packing material when reviewing applications for registration shall be public approval process and the results.     The applicant and interested parties to submit written views on matters directly related to the vital interests of State and to defend themselves.     Section II kits production applications and registered 17th claimant applied for drug packaging materials production, shall, upon completion of the medicine package development work, fill out the application form for registration of the charge material to the local provinces, autonomous regions and municipalities directly under the (food) drug supervision and management departments to submit relevant information and samples.     18th article province, and autonomous regions, and municipalities (food) drug supervision management sector accepted application Hou, should in 30th within on production enterprise according to drug package material production site assessment General of requirements organization site check, meet requirements of, extraction for test with of continuous 3 batch samples, notification set or determine of drug package material test institutions for registered test; not meet requirements of, be back trial.     19th and medicinal packaging material testing institutions receiving the registration test notification and sample, should be finished in 30th inspection, certificate of inspection reports and comments submitted to the provinces, autonomous regions and municipalities directly under the (food) the pharmaceutical supervisory and Administrative Department and inform the applicant.     Registration of new drug packaging materials inspection shall be completed within 60 days.     20th of provinces, autonomous regions and municipalities (food) pharmaceutical supervisory and administrative departments shall receive drug packaging materials inspection and testing agency report and relevant opinion in the 10th form review, on-site inspection, together with inspection reports, other relevant comments and information submitted by applicants and samples be submitted to the State food and drug administration.     21st the State food and drug administration of provinces, autonomous regions and municipalities directly under the (food) information submitted by drug regulatory authorities, should be completed within 80 days technical review. 22nd the State food and Drug Administration should be completed upon completion of technical reviews of 20th for approval. 20th cannot make a decision, approved by the competent board, you can extend the 10th.     In conformity with the provisions and issue registration certificate of the charge material; do not meet requirements, approval notice will be issued.     Section III of drug packaging materials imported application and registration article 23rd applied for drug packaging materials imported by the applicants should fill in the application form for registration of the charge material, to submit relevant information and samples of the State food and drug administration.     24th State food and Drug Administration should form review of declarations in the 5th, meet the requirements of admissibility and issued a notice of acceptance and inspection notice; do not meet the requirements of the inadmissible and issued no notice of acceptance, together with the reasons.     25th inspection notification applicant one way the State food and Drug Administration established or medicine packaging tests submitted for 3 consecutive samples.     26th drug packaging materials inspection on receipt of the registration test notification and sample shall, within 60 days to test sample, survey report and comments submitted to the State food and drug administration.     27th State in accordance with the needs of the food and drug administration, you can import medicinal packaging material development and production conditions of on-site examination and sampling.     28th are received by the State food and Drug Administration drug packaging materials inspection and testing institutions in the sample report and comments, technical review should be completed within 90 days. 29th the State food and Drug Administration should be completed upon completion of technical reviews of 20th for approval. 20th cannot make a decision, approved by the competent board, you can extend the 10th.     In conformity with the provisions and issuance of the certificate of registration of imported drug packaging materials; do not meet requirements, approval notice will be issued.     Hong Kong, Macao and Taiwan medicinal packaging material manufacturer in the area of applications for registration of drug packaging materials, reference imported packaging materials processing, compliance, drug packaging materials will be issued registration certificate; do not meet requirements, approval notice will be issued. Fourth section of drug packaging materials inspection 30th registration registered drug packaging materials for drug packaging materials must be registered.     Drug packaging materials inspection including the application to register a registered drug packaging materials for sample tests and criteria review.     Sample inspection refers to drug packaging materials inspection agencies in accordance with the Declaration and medicinal packaging material standards for the sample tested.     Standards review refers to drug packaging materials inspection agencies to declare the charge in the standard method for the determination of the feasibility, scientific, targets can be set by the laboratory of quality control of drug packaging materials, such as inspections and audits.     31st and medicinal packaging material registered by the State food and Drug Administration established or medicinal packaging material testing agency.     Drug packaging materials bear the registration examination of inspection agencies, should be in accordance with the requirements of drug packaging materials national laboratory specifications, equipped with drug packaging materials and equipment appropriate to the task registry staff, compliance and medicinal packaging material testing quality assurance system of technical requirements for registration.     Article 32nd national standards have been registered in drug packaging materials, drug packaging materials inspection authority after receiving the samples shall be tested in accordance with national standards and technological change led to changes in the indicators of the quality of comprehensive analysis and, if necessary, shall require the applicant to develop appropriate quality specifications and test methods to ensure quality controllability of drug packaging materials.     Article 33rd packaging standards for review of new drugs, drug packaging materials inspection agencies subject to inspection, should also be based on the drug packaging materials research data and information, related to domestic and international similar product standard and national requirements, and on the drug packaging materials standards, inspection items and methods, such as review comments. Article 34th drug packaging materials issued by the inspection bodies of the review, it shall notify the applicant.     Applicant has objections, should appeal in the 10th to submit the drug packaging materials inspection bodies.     Drug packaging materials inspection agencies adopt the appeal shall make corresponding corrections to review comments; if you do not agree with the applicant's appeal, it should review comments and complaints of the applicants submitted in conjunction with the State food and drug administration, with a copy to the applicant and give notice of the registration test of provinces, autonomous regions and municipalities directly under the (food) the pharmaceutical supervisory and administrative departments.     35th new drug packaging materials standards, the applicant shall not entrust my original review of drug packaging materials inspection institutions to conduct research on the standard of work; the drug packaging materials inspection bodies shall accept the delegate.     Re-registration of the fourth chapter of drug packaging materials re-registration of the 36th drug packaging materials, refers to a drug packaging materials registration certificate or the expiry date of the certificate of registration of imported drug packaging materials need to continue production or import of medicines package implementation of the approval process. 37th state food and Drug Administration issued the charge material registration certificate or the imported package registration certificate is valid for 5 years.     Need to continue production or import of the expiry, the applicant shall apply for registration before the expiry of 6 months.     Article 38th of applicants apply for re-registration of drug packaging materials production, should fill out the application form for the re-registration of drug packaging materials production, while providing the relevant declarations, in accordance with the original application submitted to the provinces, autonomous regions and municipalities directly under the (food) the pharmaceutical supervisory and Administrative Department, and register test.     The 39th of provinces, autonomous regions and municipalities (food) drug supervision and management departments in accordance with the original procedures and forms require information to be reviewed, production site for biopsy. 40th article national food drug supervision authority in received province, and autonomous regions, and municipalities (food) drug supervision management sector submitted of information and drug package material test institutions on drug package material again registered samples of test report and the about views Hou, should in 40 days completed technology review, and in completed technology review Hou 20th within completed approval, 20th within cannot made decided of, by competent Council led approved, can extended 10th. In conformity with the provisions, be registered, and issue a registration certificate of the charge material.     Does not meet the requirements, approval notice will be issued.     Re-registration of 41st and medicinal packaging material import, the applicant shall fill in the application form for the re-registration of the pharmaceutical packaging materials imported, provides information on the Declaration, in accordance with the original application submitted to the State food and drug administration, and register test. 42nd are received by the State food and Drug Administration drug packaging materials inspection authority for re-registration of drug packaging materials imported sample inspection report and related advice, technical review shall be completed within 50 days, complete the vetting within 20th, 20th cannot make a decision, approved by the competent board, you can extend the 10th.     In conformity with the provisions, be registered, and issue a certificate of the registration of imported drug packaging materials, do not meet the requirements, approval notice will be issued.     43rd under any of the following circumstances, State food and drug administration shall not be registered: (a) the national ban on the use or elimination of drug packaging materials, (ii) in the application for registration had been filed within the prescribed time of drug packaging materials, (iii) failed to pass the registration test of drug packaging materials.     44th and medicinal packaging material registration certificate or the import of drug packaging materials before the expiry of the current registration certificate, the State food and drug administration no longer registered, cancellation of the original drug packaging materials registration certificate or the certificate of registration of imported drug packaging materials, and make an announcement.     Fifth chapter of drug packaging materials supplement the 45th and medicinal packaging material after it has been registered, changing standards of drug packaging materials, changing technology and drug packaging materials and the registration certificate or the imported medicinal packaging material matters, as contained in the registration certificate, the applicant shall file a supplementary application.     Supplementary application by the applicant, should be a drug packaging materials the holder of the approval certificate. 46th charge for production of supplements to the application, the applicant shall fill in the additional application form to the medicinal packaging material to the local provinces, autonomous regions and municipalities directly under the (food) submitted to the drug regulatory agency for information and instructions, provinces, autonomous regions and municipalities (food) drug supervision and management departments to review the claims data, meet the requirements of admissibility and issued a notice of acceptance.     Does not meet the requirements of the notice in inadmissible, together with the reasons.     The 47th to the admissibility of the application, are required to the manufacturer in accordance with the General principles of drug packaging materials production site assessment requirements to organize on-site inspections, provinces, autonomous regions and municipalities (food) the pharmaceutical supervisory and administrative departments shall accept medicinal packaging material within 10th of the supplementary application form review comments and information submitted by applicants and samples be submitted to the State food and drug administration.     48th article on accepted of application, need on production enterprise according to drug package material production site assessment General of requirements organization site check of, province, and autonomous regions, and municipalities (food) drug supervision management sector should in 30th within Organization for site check, meet requirements of, extraction for test with of continuous 3 batch samples, notification set or determine of drug package material test institutions for registered test; not meet requirements of, be back trial.     Drug packaging materials inspection agency after receiving the registration test notification and sample, should be finished in 30th inspection, certificate of inspection reports and comments submitted to the provinces, autonomous regions and municipalities directly under the (food) the pharmaceutical supervisory and Administrative Department and inform the applicant.     Provinces, autonomous regions and municipalities (food) pharmaceutical supervisory and administrative departments shall receive drug packaging materials inspection and testing agency report and relevant opinion in the 10th form review, on-site inspection, together with inspection reports, other relevant comments and information submitted by applicants and samples be submitted to the State food and drug administration. 49th supplement drug packaging materials imported to the application, the applicant shall fill in the additional application form to the medicinal packaging material, to submit relevant information and instructions of the State food and drug administration, the State food and Drug Administration to review the information, meet the requirements of admissibility and issued a notice of acceptance.     Does not meet the requirements of the notice in inadmissible, together with the reasons. 50th state food and Drug Administration received supplementary application filing information, should be completed in the 20th after the acceptance of the application for approval.     Technical review is required, shall be completed within 60 days after receiving the application for approval.     51st change domestic drug packaging materials manufacturer name, domestic drug packaging materials production enterprises to change site title and medicinal packaging material supplementary application by provinces, autonomous regions and municipalities directly under the (food) pharmaceutical supervisory and administrative department finished in 20th after the acceptance of the application for approval, and report to the State food and Drug Administration for record.     52nd article national food drug supervision authority on drug package material of added application for review, to drug package material added application documents form, decided whether agreed; added application of review decided should in provides of time within notification applicants, not agreed of decided should description reason; as need renewal drug package material registered card or imports drug package material registered card of, renewal new card Hou, original card be announcement cancellation.     Sixth chapter review the 53rd was returned to the application, applicants to complement test or for related information and perfect after new declaration shall, in accordance with the original application procedures. 54th applicant disagrees with the decision of rejection, you can receive an approval decision to the country in the 10th after food and Drug Administration for review.     Review is limited to the contents of the original application, the original submission of information and samples. 55th after receiving the application for reconsideration, the State food and Drug Administration re-examination decision shall be made within 50 days.     Decided to withdraw the original decision of rejection shall issue appropriate medicinal packaging material approval documents; decided to uphold the original decision, the State food and drug administration no longer accepts applications for review again.     The seventh chapter, supervise and inspect the 56th State food and drug administration of provinces, autonomous regions and municipalities (food) of pharmaceutical supervisory and administrative departments shall on the drug packaging materials production, organization and inspection and test results shall be announced.     57th State and provinces, autonomous regions and municipalities directly under the food and Drug Administration (food) drug regulatory agency established or drug packaging materials inspection authority, responsible for the supervision and administration of drug packaging materials and check the necessary inspection tasks, and issue an inspection report.     58th drug packaging materials production enterprises and units on the results of drug packing materials inspection and testing bodies if there is objection needs to file an application for re-inspection shall be used as reference of the drug administration law of the 67th article file an application for re-inspection.     The 59th State and provinces, autonomous regions and municipalities directly under the food and Drug Administration (food) pharmaceutical supervisory and administrative departments and medicinal packaging material and inspection shall not charge any fee.     60th pharmaceutical producing enterprises and medical institutions made preparations may not use drug packaging materials that are inconsistent with national standards.     Article 61st of the administrative licensing law of the 69th, 70th, article, State food and drug administration, according to the applicant or an interested person or on the basis of terms of reference, the revocation or cancellation charge material approval documents.     62nd eighth chapter legal liability has not been approved for use in drug packaging materials product catalog of drug packaging materials, 49th, 75th according to the pharmaceutical administration law section to investigate.     63rd applicant provides false information and samples, the State food and Drug Administration not to grant the application; warning given to applicants had been approved for production or import, revocation of drug packaging materials registration documents inadmissible his application within 3 years and fines of between 10,000 yuan and 30,000 yuan.     64th has not obtained the registration certificate of charge material, unauthorized production of drug packaging materials, (food) the pharmaceutical supervisory and administrative departments shall be ordered to stop production, and a fine of 10,000 yuan and 30,000 yuan fine, has the drug packaging materials (food) drug supervision and management departments supervise treatment.     Manufacturing and selling or importing substandard drug packaging materials, (food) the pharmaceutical supervisory and administrative departments shall be ordered to stop production or import, and a fine of 10,000 yuan and 30,000 yuan fines, drug packaging materials already produced or imported by the (food) drug supervision and management departments supervise treatment.     65th on the use of substandard drug packaging materials, (food) the pharmaceutical supervisory and administrative departments shall be ordered to stop using, and to a fine of up to 10,000 yuan and 30,000 yuan, packaged medicines and medicinal packaging material should be immediately taken away by the (food) in drug supervision and management oversight. 66th drug packaging materials inspection agencies in the provision of drug packaging materials testing, issues a false inspection report, (food) the pharmaceutical supervisory and administrative departments shall be given a warning and fines of between 10,000 yuan and 30,000 yuan in serious cases, cancel drug packaging materials inspection qualification.     All the legal consequences due to false inspection reports from the drug packaging materials inspection agency making the report.     67th in the implementation of the administrative license as provided herein in violation of other laws and regulations, in accordance with the provisions of relevant laws and regulations.     68th of the Nineth chapter schedule the following terms shall have the meanings herein: drug packaging materials, refers to the pharmaceutical production enterprises in the production of pharmaceuticals and medical institutions of the medicinal preparations used in direct contact with drugs packaging materials and containers.     Drug packaging materials, is not yet used in China's drug packaging materials.     And medicinal packaging material approval documents, refers to the medicinal packaging material registration certificate, the registration of imported medicine packing material certificates and the drug packaging materials of supplementary application documents and other relevant documents.     69th explain these measures by the State food and drug administration. 70th these measures shall come into effect as of the date.       Former State food and Drug Administration on April 29, 2000 by the drug packaging materials, containers regulations (interim) (State Drug Administration, 21st) repealed simultaneously.       Annex directory: Annex: 1. implementation registered management of drug package material products directory; 2. drug package material production application information requirements; 3. drug package material imports application information requirements; 4. drug package material again registered application information requirements; 5. drug package material added application information requirements; 6. drug package material production site assessment General; 7. drug package material production clean room (district) requirements.     Annex 1: implementation registered management of drug package material products directory a, and infusion bottle (bags, and film and the accessories); II, and ampoule; three, and medicinal (injection agent, and oral or topical formulations) bottle (tube, and cover); four, and medicinal rubber plug; five, and medicinal pre irrigation seal syringe; six, and medicinal drops eye (nasal, and ear) agent bottle (tube); seven, and medicinal hard tablets (film); eight, and medicinal foil; nine, and medicinal ointment tube (box); ten, and medicinal spray (gas) fog agent pump (valve, and tank, and tube);       Cheung desiccant.     Annex 2: drug packaging materials production information, claims data directory (a) provincial (food) and Drug Administration to declare the drug packaging production of assessment reports.     (B) the State food and drug administration sets or determine drug packaging materials Inspection Agency issued three declarations of product quality inspection report.     (C) established or designated by the State food and Drug Administration drug packaging materials or inspection certificate issued by the clean room (area) of cleanliness inspection report.     (D) apply for a business license.     (E) declare their production, sale and application of products.     (F) Declaration of product formulations.     (G) Declaration of the production process and the main production and inspection equipment.     (H) Declaration of product quality standards.     (I) the three declared product manufacturer self test report.     (J) the stability testing of the drug at the same time for declaration of product packaging (medicine compatibility test) data.     (11) reporting production plant and cleanroom (area) plan.     (12) the declared product manufacturing enterprises environmental protection, waste emissions, comply with the relevant national legal provisions such as fire safety, access to the relevant certificates.     Second, the reporting requirements (a) subparagraphs (a), (b), (c) the information shall provide the original.     (B) this subsection (d) information, you can provide a copy.     (C) subparagraphs (VII) information for packaging materials or corporate standards of new drugs, should also provide drafting instructions.       (D) subparagraphs (h) the information shall be submitted within one year from the date of Declaration of the original test report books.     Annex 3: drug packaging materials imported data, claims data directory (a) producer legal production qualification certificate, notarized document and its Chinese translation. (B) the registration declared by manufacturer authorized China agency delegation instruments, notarized document and its Chinese translation.     Agency in China commercial licenses of permanent offices in China or declare the product manufacturer of the certificate of registration of resident representative offices of foreign enterprises.     (C) declare their products in foreign production, sale and application of survey and application in China registered reasons requiring special instructions.     (D) the State food and drug administration sets or determine drug packaging materials Inspection Agency issued three declarations of product quality inspection report.     (E) clean room (area) of cleanliness and three batches of product self test report the test report.     (F) Declaration of product formulations.     (G) Declaration of the production process and the main production and inspection equipment.     (H) Declaration of product quality standards.     (IX) together with the Declaration of product packaging and drug stability testing (drug compatibility test) data.     (J) the declared production plant and cleanroom (area) plan. Second, the reporting requirements (a) mentioned in sub-paragraph (a) information shall be submitted by the country of origin of the applicant Government approval of its drug packaging materials production and copies of documentary proof of business (equivalent to our business license, permit, or certificate of registration), the original of a notarized document.     Of which: 1. any drug packaging in the national Government of the country of origin listed for special approval, you must provide proof of such authorization.     2. where the approval of the Government of the country of origin without the specifically stated, instructions, may be exempted from providing this information.     (B) this subsection (ii) information reporting products manufacturer authorized agency agent in China of delegation instruments, notarized documents are required to provide the original of the Agency in China commercial licenses of permanent offices in China or declare the product manufacturer of the certificate of registration of resident representative offices of foreign enterprises can provide copies.     (C) subparagraphs (iv) information, it shall provide originals, you can begin the technical review process alone would be submitted.     (D) subparagraphs (v) information shall submit the report within one year of the date of the original inspection report.     (E) the item (VIII) information for packaging materials or corporate standards of new drugs, should also provide drafting instructions. (F) all information submitted shall be in Chinese and English, and other types of information can be attached as a reference.       Chinese translation should be consistent with the original content.     Annex 4: applications for re-registration of drug packaging materials information requests, production applications for re-registration of medicinal packaging material data requirements (a) the list of declarations 1. my Office issued the charge material approval documents and approval of changes to documents.     2. proof of legal registration of the applicant.     3. the national food and drug administration sets or determine drug packaging materials Inspection Agency issued three declarations of product quality inspection report.     4. the established or designated by the State food and Drug Administration drug packaging materials or inspection certificate issued by the clean room (area) of clean audit report.     5. Declaration of product formulations.     6. Declaration of the production process and the main production and inspection equipment.    7. Declaration of product quality standards. 8. three reporting product manufacturer self test report.     9. the product summary report on the sales and quality within five years.     10. approval of the product registration or registration to continue the implementation of completed work.     (B) the reporting requirements 1. subparagraphs (a), (b) information, you can provide a copy.     2. subparagraphs (c), (d) information, it shall provide originals.     3. subparagraphs (v), (vi) information on changed when comparing to the previous registration, it should be noted that specific content changes.     4. the above paragraph (g) of the information, and then to revise quality standards when they register, shall provide the original quality standard, the revised quality standards and amend the description.     5. the above paragraph (VIII) information shall be submitted within one year from the date of Declaration of the original inspection report.     6. subparagraphs (IX) information shall include sales, use of the product manufacturer and the list of varieties of the packaged drug, users of the product evaluation, quality testing, and drug packaging materials manufacturer on products from qualified, there is no quality accident and official quality inspection and so on.     Second, re-registration of imported medicine packing material application information requirements (a) the list of declarations 1. my Office issued the charge material approval documents and approval of changes to documents.     2. the producer legal production qualification certificate, notarized document and its Chinese translation. 3. registration declared by manufacturer authorized China agency delegation instruments, notarized document and its Chinese translation.     Agency in China commercial licenses of permanent offices in China or declare the product manufacturer of the certificate of registration of resident representative offices of foreign enterprises.     4. the national food and drug administration sets or determine drug packaging materials Inspection Agency issued three declarations of product quality inspection report.     5. clean room (area) of cleanliness and three batches of product self test report the test report.     6. Declaration of product formulations.     7. Declaration of the production process and the main production and inspection equipment.     8. Declaration of product quality standards.     9. the products sold in China in three years and the quality summary report.     10. approval of the product registration or registration to continue the implementation of completed work.     (B) disclosure requirements 1. mentioned in sub-paragraph (a) of the information, you can provide a copy. 2. subparagraphs (b) information shall be submitted by the country of origin of the applicant Government approval of its drug packaging materials production and copies of documentary proof of business (equivalent to our business license, permit, or certificate of registration), the original of a notarized document.     Where: (1) where a drug packaging in the national Government of the country of origin listed for special approval, you must provide proof of such authorization.     (2) where the approval of the Government of the country of origin without the specifically stated, instructions, may be exempted from providing this information.     3. subparagraphs (iii) information reporting products manufacturer authorized agency agent in China of delegation instruments, notarized documents are required to provide the original of the Agency in China commercial licenses of permanent offices in China or declare the product manufacturer of the certificate of registration of resident representative offices of foreign enterprises can provide copies.     4. the above paragraph (d) of the information, it shall provide originals.     5. the above subsection (e) information shall submit the report within one year of the date of the original inspection report.     6. subparagraphs (vi) and (VII) information when comparing to the previous registration changes, it should be noted that specific content changes.     7. the above item (VIII) information and registration amendments to the quality standards, shall provide the original quality standards, revised quality standards and to amend the description.     8. subparagraphs (IX) information should be included in the annual sales in China, the use of the drug manufacturers and the list of varieties of the packaged drug, the user of this product evaluation, quality testing, and drug packaging materials manufacturer for this product from qualified, there is no quality accident and Government quality inspection and so on. 9. all information submitted shall be in Chinese and English, and other types of information can be attached as a reference.       Chinese translation should be consistent with the original content.     Annex 5: drug packaging materials additional application requirements, drug packaging materials supplement classification (a) the State food and Drug Administration approved the supplementary application: 1. the change of drug packaging materials contained in the registration certificate "specifications" project.     2. the change of drug packaging materials manufacturer address.     3. change of imported packaging materials contained in the registration form "company name" and "address".     4. change in package formula of raw material producers.     5. change the charge of formula additives.     6. change of drug packaging materials, production.     7. changes and medicinal packaging material standard.     (B) directly reported to the State food and Drug Administration filed a supplementary application: 8. change registration of imported medicine packing material Agency.     (C) at the provincial level (food) and Drug Administration approval, the State food and Drug Administration filed a supplementary application: 9. the change of domestic drug packaging materials manufacturer name (name change of address a package containing material production enterprise).     10. domestic drug packaging materials manufacturer changed medicine packaging materials production sites.     Second, drug packaging materials supplement application information item 1. medicinal packaging material copies of approval documents.     2. provincial (food) after Drug Administration to change the production site for the examination report.     3. the national food and Drug Administration established or designated inspection agency issued three declarations of change the quality of the original inspection report.     4. the national food and drug administration sets or identify inspection bodies issued after change of production site in clean room (area) clean original inspection report.     5. after change of raw material sources, the quality of implementation of quality standards and inspection report.     6. after change of material sources, the basis of implementation of standards of quality and safety.     7. change production processes before and after comparison of research data.     8. change registration instructions and change the registration criteria before and after.     9. after the Declaration of change of variety of original manufacturing enterprise quality inspection report.     10. after change of declared drug stability testing of joint research information on packaging (including investigational product quality standards).     11. change of production plant and clean room (area) plan.     12. change before and after the lawful copy of the registration certificate of the applicant; import medicinal packaging material manufacturers approved by the competent authority of the host country change "company name" or "address" application related documents, notarization of documents and its Chinese translation. 13. imported pharmaceutical packing material manufacturers authorized the new China agency report of delegation instruments, notarized document and its Chinese translation.     New Chinese business license of the Agency with copies of original documents of the Agency agreed to give up acting. Third, drug packaging materials description of the supplemental application information list: 1. "           + "Representative needs to submit;"-"representatives do not need to submit.           2. the "*1" application for the imported drug packaging materials do not need to submit this information; "*2" relate to import medicinal packaging material in the application in accordance with annex III (e) information about the clean room (area) cleanliness test report submitted this information.       3. handling the imported drug packaging materials on the supplementary application in addition to the information required by form, but still required imported medicine packing material manufacturers Declaration of the authorized agency delegation instruments, notarized document and its Chinese translation, China agency business license copy or declare permanent representative offices of production enterprises of the copy of the certificate of registration of resident representative offices of foreign enterprises.     Annex 6: article I general principles of drug packaging materials production site assessment to strengthen direct contact with drugs packaging materials and containers (hereinafter "medicines package") management to ensure drug quality, under the Pharmaceutical Affairs Law, regulations for the implementation of the drug administration law and the direct contact with the pharmaceuticals packaging materials and containers regulations relevant provisions are formulated the General Act.     Article II of the General drug packaging materials production and the basic principles of quality management, applied to drug packaging materials in the production process. Third institutions and personnel of drug packaging materials production enterprises should set up and production requirements of production and quality control agencies.     Institutions at all levels and staff responsibilities should be clear, and is equipped with a number of drug packaging materials production compatible with expertise, experience and organizational skills of managers and technical staff.     Fourth charge of drug packaging materials production management and should have the head of quality management and product-related expertise, experience in the production and quality control of products, on the implementation of the General principles of and is responsible for product quality. Fifth of drug packaging materials production management and quality management department head should have the relevant background and experience in the production and quality control of these products.     Drug packaging materials have the ability to make the right judgment and practical problems in quality management and process.     Drug packaging materials production management and quality control department head shall not be concurrently with each other.     Sixth engaged in drug packaging materials production and quality inspection shall be subject to professional and technical training of personnel, with the basic theoretical knowledge and practical skills.     Seventh for drug packaging materials in the production of all categories of personnel should be carried out according to the requirements of the General training and assessment. Plant and facilities article eighth drug packaging materials production enterprises must have a clean production environment; the factory ground, road and transport such products should not lead to pollution; production, management, and the overall layout of a secondary zone should be reasonable and must not hinder each other, plant major roads should be spacious, pavement, and select easy to clean material.     Plant design and construction shall conform to the relevant regulations of the State. Nineth workshop should be in the production process and the rational distribution of air cleanliness level required.     In the same building, and between adjacent plant production operations must not hinder each other.     Tenth Workshop dust, pollution prevention, protection against insects and other animals and foreign bodies to enter the facility. In the design and construction of factory building, the 11th should be considered (when used), easy to clean.     Clean room (area) of the inner surfaces should be smooth, without cracks and interfaces closely, no particles fall off, and resistant to cleaning and disinfection, the border between the walls and the floor should be into an arc or take other measures to reduce dust accumulation and easy to clean.     12th production areas and storage areas should be commensurate with the scale of production area and space for the installation of equipment, material, ease of operation, stored materials, intermediate products, quarantine and finished product, should minimize errors and cross-contamination. 13th entering the clean room (area) of the air must be clean.     Don't wash the drug packaging materials, products (including) after their cleanliness requirements of each process should be same as the cleanliness of the pharmaceutical production and packaging, according to requirements, drug packaging materials production in clean room (area) of air cleanliness is divided into four levels (see "clean room (area) of air cleanliness levels table"). 14th clean room (area) of management required to meet the following requirements: first, clean room (area) number of staff should be strictly controlled.     The staff (including maintenance, support staff) should be carried out regularly health and microbiology basics, clean jobs training and assessment; on entering the clean room (area) of temporary foreign workers should carry out guidance and supervision.     Second, clean room (area) and non clean room (area) must set up buffer between facilities, people and logistics to a reasonable. Third, clean room (area) of piping, lamps, sealed within, as well as other public facilities, design and installation should be considered to avoid difficult to clean parts.     Equipment insulation layer's surface should be smooth and clean, no particles fall out.     Four, clean room (area) within the use of casts, easy to clean, easy to disinfect health tools health tools to be deposited in the designated area does not cause pollution, and restrictions on the use of area. Five, clean room (area) of adequate lighting should be provided according to the production requirements. Main Studio illuminance appropriate for 300 Lux; control of production parts to set local lighting with special requirements.     Plant will have emergency lighting facilities. Six, clean room (area) of Windows, ceiling and access to indoor plumbing, ventilation, lighting and wall or ceiling joints shall be sealed.     Air cleaner with various levels of static pressure difference between adjacent rooms should be greater than 5 kPa, in clean room (area) and outdoor air static pressure difference greater than 10 kPa, in clean room (area) and non clean room (area) of static differential pressure should be greater than 5 kPa, and there should be instructions static differential pressure devices. Seven, clean room (area) of temperature and relative humidity should be commensurate with the drug packaging materials, production.     No special requirements, the temperature should be controlled 18~26℃, relative humidity control in 45~65%. Eight, clean room (area) of detected dust particles in static conditions, number of planktonic bacterial cell population or settlement must comply with the requirements of monitoring dynamic conditions on a regular basis and clean condition. Monitor the number of ventilators, static pressure difference parameter.     All monitoring results shall be documented. Nine, clean room (area) of installed products from sinks, floor drains shall not pollute.     Class 100 clean room (area) may not be set within a floor drain, the operator should not bare-handed operation, when the inevitable, the hand should be disinfected in a timely manner.     Ten, class 10,000 clean room (area) of the transmitting equipment shall not be used through lower-level areas.     Third, more than 100,000 class clean work clothes should be clean room (area) in the washing, drying, sorting, if necessary, should be sterilized as required.     12, air purification systems, should be required to clean, repair, maintenance and records.     15th Workshop if necessary, dust-proof and dust-catching facility.     16th in clean room (area) used to dry the air, compressed air and inert gas purification process, in line with production requirements. 17th storage areas should be kept clean and dry.     Facilities such as lighting, ventilation, temperature, humidity control, the storage requirements and regular monitoring. 18th inspection, sampling of the quality control Department set observation, as well as other types of laboratories and drug packaging materials should be separated from production areas.     Microbial limit test of chemical testing and lab.     19th to the special requirements of the instruments, meters, instruments should be placed in a special room, and prevents static electricity, vibration, moisture or other external factors affecting a range of facilities.     20th equipment design, equipment selection and installation shall conform to the requirements for easy cleaning, disinfection or sterilization, ease of operation and maintenance, maintenance, and can prevent errors and reduce pollution. 21st do not wash drug packaging materials in direct contact with surface should be smooth, easily cleaned or disinfected, corrosion-resistant, and chemical change in drug packaging materials.     Equipment used in lubricants, coolant and other drug packaging materials shall not cause pollution.     The 22nd main fixed pipe tube should be marked with the device item name and direction.     23rd for the production and testing of instruments, meters, measuring, weighing, its scope and precision, the production and inspection requirements, there are obvious signs of qualified and calibrated regularly. 24th production equipment should be obvious status symbol, and periodic repair, maintenance, and validation. Equipment installation, repair and maintenance operations should not affect the quality of the product.     Failed device should if possible be moved out of the production area, there should be obvious signs without having to move out.     25th production, test equipment should be regularly maintained and repaired, shall be used, maintenance records, and expert management.     26th and medicinal packaging material used in the production of material items purchased, storage, distribution, use of management systems should be developed. 27th and medicinal packaging material used in the production of materials, should be consistent with national legal standards or other standards shall not have an adverse impact on the quality of medicines.     Using imported raw materials quality inspection departments of the port inspection report.     28th and medicinal packaging material used in the production of materials purchased should be in conformity with the provisions and required storage. 29th to be inspected, qualified and non-qualified items are to be strictly managed.     Substandard materials to zone storage, easily recognizable symbols, and treated in accordance with relevant provisions. 30th of temperature, humidity or other conditions has special requirements for materials, intermediate products and finished products should be stored as required.     Solid and liquid raw materials should be stored separately of volatile materials should be taken to avoid contamination of other materials. 31st item should be required to use the term store, no deadlines, retest period should be established, should retest after the expiration.     Storage period if exceptional circumstances shall be timely to reinspect.     Article 32nd drug packaging materials, labels, manuals must be sanctioned by the quality control Department proof is correct reproduction, distribution and use, there is someone keeping, using, its requirements are as follows: first, the labels and instruction manuals should be varieties and specifications have a counter or stock, issued by the packaging directive, according to the actual requirements to receive.     Second, the label granted to count, lead employment checks, signatures, use number, the number of damaged and remaining number and be aligned with the requisition number, damaged or remaining labels bearing batch numbers destroyed by the person responsible for counting.     Three, tag issuance, use, destruction of records.     33rd medicinal packaging material production enterprise of health health measures should be taken to prevent pollution, developing health management systems, and accountability.     34th drug packaging materials production, process, post production and air cleanliness class required plant, equipment, containers, cleaning procedures, should include: cleaning methods, procedures, time interval, using detergents or disinfectants, cleaning tools and storage sites. 35th production areas shall be kept non-production goods and personal items.     Production of waste should be processed in a timely manner.     36th, dressing room, bathroom and toilet settings may not clean room (area) of adverse effects. The 37th selection in work clothes, style and wearing way should be compatible with the operation of air cleanliness level and shall not be mixed. Clean and coat texture should be smooth, not static, does not shed fibers and particulate matters.     Sterile clothing must cover all hair, beard and legs and can detain the body casts. 38th different air cleanliness levels used work clothes, respectively cleaning, sorting and, if necessary, disinfection and sterilization. Clothes washing and sterilization should not be brought into the addition of particulate matter.     Work clothes cleaning cycle should be developed.     39th in clean room (area) is limited to operators in the region, and approved personnel.     40th entering the clean room (area) of personnel not wearing makeup and jewelry. 41st in clean room (area) should be disinfected on a regular basis. Disinfectants used shall not have a contamination on equipment, materials and finished products.     Disinfectants should be changed regularly to avoid drug-resistant strains. 42nd drug packaging materials production staff should have a health record. Production personnel examination at least once a year.     Patients with infectious diseases, skin diseases and skin wounds may not engage in direct contact with the pharmaceuticals, does not charge for washing the material production. File 43rd article drug package material production enterprise due production management, and quality management of the system and records: a, and plant, and facilities and equipment of using, and maintenance, and maintenance, and maintenance, system and records; II, and material acceptance, and production operation, and test, and issued, and finished sales and user complaints, system and records; three, and not qualified products management, and material back library and scrap, and emergency situation processing, system and records; four, and environment, and plant, and equipment, and personnel, health management system and records; five, and this General     And professional technology training, system and records; 44th article products production management file main has: a, and production process, and post operation method or standard operation production process procedures of content including: finished name, and specifications, and formula, and production process of operation requirements, material, and middle products of quality standard and technology parameter and the store note matters, material balance of calculation method, finished container, and packaging material of requirements,.     Method of operation includes: production methods and key points, focusing on operational review, review, product standards and quality control, safety and labour protection, equipment maintenance, cleaning, exception handling, and package covers, sanitary and environmental health.     Standard procedures include: title, number, maker and date of enactment, audits and the audit date, approved and the approval date, the issuing sector, effective date, the distribution sector, title and body text.     Second, batch production, batch production records include: product name, lot number, date of production, operation and review of signature, for operations and equipment, related to the production phase of the product quantity, material balance calculation, production process control records and recorded a special issue.     45th product quality management documents are:, medicine packing material and the application documents, registration certificates, approved material approval document; the second, materials, intermediate products and finished product quality standards and inspection procedures; the third, product quality stability; four, inspection records. 46th and medicinal packaging material production enterprises should set up document drafting, revision, review, approval, printing and storage management systems. Distribution and use of the documents should be approved by the existing text.     Retired, and obsolete files in addition to files outside the record, not at the work site.     47th article developed production management file of quality management file of requirements: a, and file of title should can clear to description file of nature; II, and various file due easy recognition its text, and category of system coding and date; three, and file of using of language should exact, and understand; four, and fill in data Shi due enough of spaces; five, and file developed, and review and approved of responsibility should clear, and and has responsibility people signature. 48th production production management processes, operations and standard operating procedures shall be subjected to arbitrary change of position.     If you need to change, according to the procedures under revision, and approval procedures. 49th each batch of products according to the quality and quantity of material balance checks.     If there are significant differences, must discover the cause, come up with a reasonable explanation, after making sure that no potential accidents, can be processed according to normal products. 50th batch production records shall be legible, content authenticity, data integrity, and signed by the operator and reviewed.     Records should be kept clean and tidy, not torn or arbitrarily alter; change, change signature, and the original data is still recognizable.     By batch number batch production records should be archived and saved to one year after the product is sold. 51st within specified limits have the same nature and quality, and produced in the same production cycle of a number of drug packaging materials products for a number of.     Each batch of product batch shall be established.     52nd article for prevent drug package material products was pollution and confusion, production operation should take following measures: a, and production Qian should confirmed no last production legacy real; II, and should prevent dust of produced and diffusion; three, and different products varieties, and specifications of production operation should take effective measures isolation; four, and production process in the should prevent material and the products by produced of gas, and steam, and spray real or organisms, caused of cross pollution. 53rd according to product selection process water used in the process. Water used in the process of preparation, storage and distribution to prevent breeding ground for microbes and pollution. The material used should be nontoxic, corrosion, regular cleaning, disinfection, water should be able to meet the needs of production. Process water shall conform to the quality standards, and periodic inspection, inspection records.     Should be based on the results, provides inspection cycle. 54th medicinal packaging material production enterprise of quality management quality management Department is responsible for the whole production process of the product quality management and testing, directly led by the business leaders.     Quality Management Department should be equipped with a number of quality management and inspection personnel, and drug packaging materials production, varieties, adapted to the testing requirements for premises, instruments and equipment. 55th article quality management sector of main duties: a, and developed and amendment material, and middle products and finished of internal control standard and test operation, developed sampling and left sample System; II, and developed test with equipment, and instrument, and reagents, and try liquid, and standard products (or control products), and titration liquid, and medium, management approach; three, and decided material and middle products of using; four, and audit finished issued Qian batch production records, decided finished issued; five, and audit not qualified products processing program; decided on return, and     Recovered and not qualified products of processing method; six, and on material, and middle products and finished for sampling, and test, and left sample, and issued test report, batch test records save to products sales Hou a years; seven, and monitoring clean room (district) of dust number and microbial number; eight, and evaluation raw materials, and middle products and the finished of quality stability, for determine material store period, and products using period provides data; nine, and developed quality management and test personnel of duties.     56th quality management Department shall, in conjunction with the relevant departments of the major material suppliers quality system assessment. Evaluate the suppliers of raw materials.     For production environments, quality guarantee, whether to comply with State certification and reputation were investigated, to ensure that the raw material quality, the supplier should be stable. 57th of each batch of finished products should be sold records. According to sales records to trace each batch of drug packaging materials products sold, can all recover in time when necessary.     Records should include: the name, lot number, size, number, consignee and address and delivery date.     58th sales records should be kept to one year after the product is sold. 59th medicinal packaging material production enterprises shall establish product return and recovery of written procedures and records.     Product return and recovery of records should include: the name, lot number, size, quantity, return and recovery and address, the date and reason for return and recovery of, and comments.     For quality reasons, return and recovery of products should be classified as nonconforming product processing under the supervision of the quality control Department, when it comes to other batches, should be dealt with simultaneously.     Self-test 60th and medicinal packaging material production enterprises shall be governed by the provisions on the procedure of personnel, premises, equipment, documentation, production, quality control, product sales and product recovery process is regularly checked to confirm with the General principles of consistency. 61st self test should be recorded.     After the self-test is complete the self test report, including inspection results, conclusions and the measures and recommendations of the evaluation.     Schedule to the 62nd article of the general meaning of the following terms: material: raw materials, auxiliary materials, packaging materials, and so on. Lot number: used to identify the "batch" of a set of numbers or letters and numbers.     To go back and review the product's production history.     Quarantine: allow feeding of material or factory's on hold, waiting for the test results. The batch production record: a Bulk Product or finished product batch production records.     Batch records can provide the product's production history, and quality-related conditions.     Mass balance: the theoretical yield of products or materials or theories compared with the actual production or consumption of, and with due regard to permissible deviation of normal.     Standard operating procedure: approved for the versatility of the instructions file or management approach.     Production process: provides for the production of a number of products required for starting material and the amount of packaging material and processing, processing instructions, attentions, including control of a production process or a set of files.     Clean room (area): the need for a dust particle and microbiological controlled rooms (area), its buildings, equipment and its uses have reduced pollution in the region involved, and retention functions.     Validation: that any procedure, process, equipment, material, activity or system can achieve the desired results of relevant documents to prove that a range of activities.     Validation should include drug packaging materials production premises, facilities and equipment installation qualification, operational qualification and performance verification and product validation. Validation should be developed according to the validation sample validation projects, programmes and organizations.    Upon completion of the validation should write a validation report, verification by the staff review and approval. Validation and analysis of data should be archived as a file.     Verify that the document should include verification and validation report, evaluations and recommendations, approval and so on. 63rd article of the rules issued by the State food and drug administration of direct contact with the pharmaceuticals packaging material and container management measures implemented from the date of promulgation.     Description: a, the rating schedule according to the State food and Drug Administration set out in the General principles of drug packaging materials production site assessment. Second, the content of this statement of scoring a total of 7 major 60, a total of 600 points. The distribution shown in the table below:

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