Police tactical unit products are national health food marks approved by the US Food and Drug Administration! The special symbol of health food in China is sky blue and hat shape, which is commonly known as "police tactical unit" or "little blue hat" in the industry.
About drug GMP certification: the validity period of drug GMP certificate is 5 years. The GMP certificate of newly established pharmaceutical manufacturing enterprises is valid for 1 year. Pharmaceutical production enterprises shall reapply for GMP certification six months before the expiration of the validity period. The newly established pharmaceutical production enterprise shall apply for reexamination 3 months before the expiration of the validity period, and issue a GMP certificate with a validity period of 5 years after passing the reexamination.
GMP certification information
Requirements of GMP certification application materials 1 general information of enterprises 1. 1 enterprise information ◆ enterprise name and registered address; ◆ Enterprise production address and postal code; ◆ Contact person, fax number and telephone number (including 24-hour contact person and telephone number in case of serious drug injury or recall). 1.2 pharmaceutical production of the enterprise ◆ Briefly describe the production activities approved by the (food) drug supervision and administration department of the enterprise, including information on imported and repackaged drugs, exported drugs, overseas licensed drugs, etc. ◆ Business license and pharmaceutical production license, and copies of relevant certification documents issued by overseas institutions are required for export; ◆ All varieties that have obtained the approval number (can be filled in by factories at different addresses, and indicate whether they are produced all the year round, with the output list of the last three years attached); ◆ Is there any operation for handling highly active and highly sensitized materials such as highly toxic and sex hormone drugs at the production address? If so, it should be listed and marked in the annex. 1.3 Scope of this application for drug GMP certification ◆ List the production lines, production dosage forms and varieties of this application for drug GMP certification, and attach copies of registration approval documents of related products; ◆ The latest inspection of the production line by the (food) drug supervision and administration department (including inspection date, inspection results, defects and rectification, with relevant GMP certificates attached). If the production line has passed the GMP inspection of foreign drugs, the inspection situation should be provided together. 1.4 main changes since the last GMP certification ◆ Briefly describe the changes of key personnel, equipment, facilities and varieties after the last certification inspection. 2. Enterprise's quality management system 2. 1 Description of enterprise's quality management system◆ Relevant management responsibilities of the quality management system, including the responsibilities of the top manager, the person in charge of quality management, the quality authorizer and the quality assurance department; Briefly describe the elements of quality management system, such as organization, main procedures and processes. 2.2 finished product release procedures ◆ Overview of release procedures and basic information (qualifications, etc. ) personnel responsible for the release. 2.3 Supplier management and commissioned production inspection ◆ Summarize the requirements of supplier management and the quality risk management methods used in the review; ◆ Briefly describe the situation of entrusted production; (if any) ◆ Briefly describe the entrusted inspection. (if any) 2.4 Quality risk management measures of the enterprise ◆ Briefly describe the quality risk management policy of the enterprise; ◆ The scope and focus of quality risk management activities, and the process of risk identification, evaluation, control, communication and audit under the quality risk management system. 2.5 Annual product quality retrospective analysis ◆ Annual product quality retrospective analysis and investigation focus conducted by enterprises. 3. Personnel 3. 1 Organization chart of quality assurance, production and quality control (including senior management personnel) and organization chart of corresponding quality assurance, production and quality control departments respectively; 3.2 Qualification of key personnel of the enterprise and main technical personnel engaged in quality assurance, production and quality control; 3.3 Number of employees in quality assurance, production, quality control, storage and delivery departments. 4 Plant, facilities and equipment 4. 1 Plant◆ Briefly describe the completion and use time and type (including structure, internal and external surface materials, etc.). ) and the site area of the building; ◆ The general plan of the factory, the layout and flow chart of the production area, indicating the proportion. The cleanliness level of the room and the pressure difference between adjacent rooms should be marked, and the production activities carried out in the room can be indicated; ◆ Briefly describe the layout of all production lines within the scope of application for certification; ◆ Briefly describe warehouses, storage areas and special storage conditions. 4. 1. 1 Brief description of air-conditioning purification system ◆ Working principle, design standard and operation of air-conditioning purification system, such as intake air volume, temperature, humidity, pressure difference, air exchange times and return air utilization rate, etc. 4. 1.2 Brief introduction of water system ◆ Working principle, design standard, operation and schematic diagram of water system. 4. 1.3 Brief introduction of other public facilities ◆ Working principle, design standard and operation of other public facilities such as compressed air and nitrogen. 4.2 Equipment 4.2. 1 lists the main instruments and equipment for production and inspection. 4.2.2 Cleaning and disinfection ◆ Briefly describe the methods and verification of cleaning, disinfection and direct contact of drugs with the equipment surface. 4.2.3 Key computerized systems related to drug production quality ◆ Briefly describe the design and application verification of key computerized systems related to drug production quality. 5 file ◆ Describe the file system of the enterprise; ◆ Briefly describe the system of document drafting, revision, approval, distribution, control and filing. 6 6. 1 Production situation of products produced ◆ Overview of products produced (brief description); ◆ Process flow chart of the dosage forms and varieties to be certified this time, and indicate the main quality control points and items. 6.2 Process verification ◆ Briefly describe the principle and general situation of process verification; ◆ Briefly describe rework and the principle of rework. 6.3 Material management and storage ◆ Handling of raw and auxiliary materials, packaging materials, semi-finished products and finished products, such as sampling, inspection, release and storage; ◆ Disposal of unqualified materials and products. 7 Quality control ◆ Describe all activities carried out by the enterprise quality control laboratory, including inspection standards, methods and verification. 8. Transportation, Complaints and Recall 8. 1 Transportation ◆ Briefly describe the control required by the product during transportation, such as temperature/humidity control; ◆ Methods to ensure product traceability. 8.2 Complaints and recalls ◆ Briefly describe the procedures for handling complaints and recalls. 9 Self-inspection ◆ Briefly describe the self-inspection system, focusing on the regional selection criteria, self-inspection implementation and rectification in the planned inspection.
Edit this GMP certification process.
1. The reporting enterprise submits the certification application and application materials to the acceptance hall of the provincial bureau. 2 provincial drug safety supervision department to review the application materials (5 working days). 3. The Certification Center shall conduct technical review of the application materials (10 working days). 4. The certification center shall make an on-site inspection plan (10 working days). 5. The provincial bureau approved the scheme (65438+) and the certification center organized and implemented the on-site inspection of certification (10 working days). 7. The certification center conducts a preliminary examination of the on-site inspection report (10 working days). 8. Preliminary examination opinions of the provincial bureau for approval and certification (10 working days). 9. Report to the National Bureau for review announcement (10 working days).
Apply for the blue hat mark of health care products
Guide to the application for registration of health food 1. Accepting unit, address and time: Health food receiving office of the Health Food Evaluation Center of the US Food and Drug Administration Address: 5th floor, Building Fanan Li Nan 1 1, Chongwen District, Beijing Postal code: 1006 1 2. Health food receiving office. Procedures for examination and approval of health food domestic health food The drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government are responsible for the acceptance and formal examination of the application materials for registration of domestic health food, on-site verification of the health food test and sample trial-production applied for registration, and organization of sample inspection. When importing health food, the applicant shall submit the application materials and samples to the US Food and Drug Administration. Three. General requirements for application materials (1) The first page of the application materials is the catalogue of application materials, and the application materials in the catalogue are arranged in the order of the materials attached to the health food registration application form. Each document has a cover, which indicates the product name and the applicant's name, and the name of the document is indicated in the upper right corner. There should be obvious difference marks between materials, and the name of the material or the number in the catalogue where the material is located should be indicated. The whole set of materials is bound into a book with punching clips. (2) The application materials shall be printed on A4 paper (No.4 in Chinese andNo. 12 in English), and the contents shall be complete and clear, and shall not be altered. (3) In addition to the health food registration application form and the inspection report issued by the inspection agency, the application materials should also be stamped with the applicant's seal or riding seal page by page (if multiple applicants jointly declare, they should be stamped with the seals of all applicants), and stamped with the seal at the end of the text. The stamped seal shall conform to the relevant provisions of the state and have legal effect. (4) Where multiple applicants file jointly, a letter of recommendation from the person in charge of the joint filing shall be submitted. (five) the same content in the application materials (such as product name, applicant's name and address, etc.). ) should be filled in consistently. (six) the product name should include brand name, common name and attribute name. The product name shall meet the following requirements: 1. Abide by the provisions of relevant national laws, regulations, rules, standards and norms. 2. It reflects the authenticity of the product, is concise and easy to understand, and conforms to the language habits of China people. 3. The brand name can be the registered trademark of the product or other names. 4. Generic names shall be accurate and scientific, and words that indicate or imply therapeutic effects or exaggerate functional effects shall not be used. 5. The attribute name should indicate the objective form of the product, and its expression should be standardized and accurate. 6. Products with supplementary dosage forms shall use the same brand name and common name, but different attribute names. 7. The Chinese name of the imported product should correspond to the foreign name. Free translation, transliteration or a combination of meaning and sound can be used, and free translation is generally the main method. 8. When naming health food, the following contents shall not be used: (1) technical terms and local dialects that are difficult for consumers to understand; (2) False, exaggerated and absolute words, such as high efficiency and generation; (3) Vulgar or superstitious words; (4) Foreign letters, symbols, Chinese pinyin, etc. (except registered trademarks); (5) Do not use homophonic words (words) related to functions; (6) Names and place names (except registered trademarks) shall not be used. (seven) product formula, production technology, quality standards, labels and instructions, and related foreign language documents shall be translated into standardized Chinese; Abstracts, keywords and contents related to the health care function and safety of products in foreign language references should be translated into standardized Chinese (except foreigners' names and addresses). (8) The supplementary materials submitted by the applicant shall be provided item by item according to the requirements and contents of the Notice of Comments on Health Food Review, and the Notice of Comments on Health Food Review shall be attached (original or photocopy). When submitting supplementary information, complete information of the revised project shall be provided together with the date of revision, and the official seal consistent with the original applicant shall be affixed. (9) For the accepted products, the specific requirements for the applicant to change the relevant contents of the application materials are as follows: 1. The product formula, production process, test report and other contents that may involve product safety and function shall not be changed. 2. In addition to the above contents, if it is necessary to change, the applicant shall submit a written application for change to the original acceptance department, explain the reasons for the change, indicate the date of submission, and affix the seal consistent with the original applicant. The applicant should provide complete information about the changed project. (10) The application materials and samples of products that have not been approved and registered by the State Food and Drug Administration of the United States are generally not returned, except for the power of attorney submitted, the certification documents that the products have been produced and sold in the producing country (or region) for more than one year, the certification documents issued by the relevant institutions of the producing country (or region) that the production enterprises meet the corresponding local production quality management standards, and the original Health Food Approval Certificate (except for re-registered products). If necessary, return it to the applicant. (eleven) to apply for new product registration, it shall submit 1 original application materials and 8 copies; For the application for product registration of change and technology transfer, 1 original and 6 copies shall be submitted. The copy shall be completely consistent with the original, and shall be copied by the original and kept complete and clear. Among them, the application form, quality standards and label instructions should also be provided in electronic version, and the contents should be consistent with the original. 4. Application materials for domestic health food (1) Application form for health food registration (domestic/imported) (2) A copy of the applicant's ID card, business license or legal registration certificate of other institutions should be clear and complete, stamped with the applicant's seal, and the certificate should be within the validity period. (3) Provide the retrieval materials (retrieved from the database of the government website of the State Food and Drug Administration) that the common names of health foods (except those named after raw materials) applied for registration are not duplicate with the names of drugs approved for registration, and the applicant shall issue a retrieval report after retrieval from the database of the website of the State Food and Drug Administration. For example, after searching, Yiganling tablet is the approved registered drug name, and the brand Yiganling tablet (oral liquid or capsule, etc.). ) shall not be used as the name of health food. (4) The applicant shall make a statement to ensure that the patent obtained by others does not constitute infringement, and make a commitment to this statement. If there is any falsehood, the applicant is willing to bear the corresponding legal responsibilities and bear all the consequences arising therefrom. (5) Provide trademark registration certificate (unregistered trademarks are not required). Trademark registration certificate refers to a copy of the trademark registration certificate approved by the national trademark registration administration department, and unregistered trademarks are not needed. The scope of use of trademarks should include health food. If the trademark registrant is inconsistent with the applicant, it shall provide the change document of the trademark registrant or the applicant's certificate that the trademark can be legally used. (six) product R&D report (including R&D ideas, function screening process, expected effect, etc.). ) Information shall be provided according to the requirements of the project for information application, including R&D concept, function screening process and expected effect, and each item shall be listed separately and indispensable. (seven) product formula (raw materials and accessories) and formula basis; Sources of raw materials and their use basis (VIII) Effective ingredients/iconic ingredients, contents of effective ingredients/iconic ingredients and inspection methods. This information shall be provided in accordance with the requirements of the declared data items, and the contents of effective ingredients/marked ingredients, effective ingredients/marked ingredients and inspection methods shall be listed separately, and there shall be no omissions. (nine) product quality standards (enterprise standards) and their drafting instructions, and the production process block diagram, detailed description and related research materials of raw material quality standards (ten). (eleven) the types, names, quality standards and selection basis of packaging materials in direct contact with products. (12) Inspection report issued by inspection organization (13) Sample product label and instruction manual 1. The product description should be written in the following format and requirements: Product Description This product is a health food made from the edible function test certificate of animals and/or humans as the main raw material (Note: the nutritional fortifier does not need to be marked with the words edible function test certificate of animals and/or humans, but only needs to be marked with supplementary health care functions. [Main raw materials] List the main raw materials and auxiliary materials in the order of formula writing. [Active ingredient or iconic ingredient and content] Every 100g( 100ml) contains: the content of active ingredient or iconic ingredient. The content should be a definite value. Nutrient supplements should also indicate the nutrient content of the minimum consumption unit. [Health Function] Written according to the declared health function name. [Suitable for the crowd] [Not suitable for the crowd] [How to eat and how much to eat] Once a day. If there are special requirements, please indicate the dosage for each time. [Specification] Indicate the net content of the minimum edible unit. Indicate the net content according to the following measurement unit: (1) Liquid health food: use volume, in milliliters or milliliters. (2) Solid and semi-solid health food: edible quality, with the unit of mg, g or mg, g ... (3) If there are preparations with internal packaging, such as capsules (soft capsules), the quality refers to the quality of the contents. [Shelf life] Calculated in months [Storage method] [Precautions] This product cannot replace medicines. Precautions should also be added according to product characteristics. Suitable people, unsuitable people and precautions of health food should be determined according to the claimed health function and product characteristics. (This information is provided according to Supplementary Provisions on the Declaration and Evaluation of Health Food (Trial)). 2. Product labels shall be written in the following formats and requirements: product label samples shall be written in accordance with relevant state regulations, and the contents involved in the instructions shall be consistent with the instructions. (14) Other materials helpful for product audit: 1. Including the quality assurance system documents (GMP, HACCP) certificate of the production enterprise, raw material supply certificate, raw material supply and marketing contract, entrustment agreement, raw material inspection report or factory certificate and other supporting documents, as well as research and reference materials related to product formula, process, function and safety. 2. The foreign language materials provided shall be translated into standard Chinese. (15) Two unopened minimum sales packaging samples. The sample package provided shall be intact and labeled, and the label shall be consistent with the corresponding contents in the application materials. Sample packaging should be conducive to the preservation of samples, not easy to deteriorate and damage. The sample should be within the warranty period. To apply for the registration of imported health food, in addition to providing information according to the use of raw materials and the application function, the following information must be provided: (1) certification documents issued by the relevant institutions of the producing country (region) that the production enterprise meets the corresponding local production quality management standards 1. Where the declared products are produced by an overseas production enterprise entrusted by the applicant, the production enterprise in the certification document shall be the entrusted production enterprise, and the applicant shall be provided at the same time. 2. The certification documents shall include the name of the organization that issued the certification documents, the name of the product, the name of the production enterprise and the date when the certification documents were issued; 3. The institution that issues the certification documents shall be the competent department or trade association of the country where the product is produced. (2) A copy of the registration certificate of the resident representative office of a foreign enterprise in China shall be provided for the registration of the resident representative office of a foreign manufacturer in China. Where an overseas production enterprise entrusts a domestic agency to handle registration matters, it shall provide the notarized original power of attorney and a copy of the business license of the entrusted agency. The power of attorney entrusted to handle registration affairs shall meet the following requirements: 1. The power of attorney shall specify the name of the issuing unit, the name of the entrusting unit, the name of the product entrusted for registration, the entrusted matters and the date of issuance of the power of attorney; 2. The entrusting party issuing the power of attorney shall be completely consistent with the name of the applicant; 3. When the entrusted party entrusts another agency to handle the registration affairs again, it shall provide the original and Chinese translation of the applicant's approval document, and the translation shall be notarized by the Chinese notary office. (3) A certificate that the product has been produced and sold in the producing country (region) for more than one year, notarized by the notary office of the producing country (region) and confirmed by the country where the product is located in embassies and consulates in China, and meets the following requirements: 1. The certificate shall specify the name of the issuing agency, the name of the applicant, the name of the production enterprise, the name of the product and the date of issuance. 2. The certification documents shall clearly show that the products comply with the laws and relevant standards of the country (or region) and are allowed to be produced and sold in the country (or region). If it is only allowed to be produced in this country (or region) and not allowed to be sold in this country (or region), the application for registration of such products will not be accepted. 3. The institution issuing the certification documents shall be the competent government department or trade association of the producing country. (4) Relevant product standards of the producing country (region) or international organizations (5) Samples of packaging, labels and instructions of products listed in the producing country (region). It should be listed under the label and instruction sample. The above application materials must be in Chinese with the original text attached, and foreign materials can be attached for future reference. Chinese translation should be notarized by domestic notary organs to ensure consistency with the original content; The product quality standard (Chinese version) applied for registration must conform to the format of China health food quality standard. Also note the following: 1. The name of the product, the name of the applicant, the name of the manufacturer and the name of the agency (in Chinese and English) should be consistent. 2. The certification documents and power of attorney shall be original, and shall be notarized by the notary office of the producing country (or region) in the official language of the producing country (or region) and confirmed by the Chinese embassy (consulate) in that country. 3. If the validity period is stipulated in the certification documents and power of attorney, it shall be used within the validity period. 4. The certification documents and power of attorney shall be sealed by the unit or signed by the legal representative (or its authorized person). 5. The supporting documents and power of attorney shall be translated into Chinese and notarized by a notary office in China. Intransitive verb domestic health food 1 Requirements and explanation of change application materials. The functional name, raw (auxiliary) materials, technology, eating method, expanding the range of suitable people, narrowing the range of unsuitable people and other contents that may affect the safety and functionality specified in the health food approval certificate shall not be changed. 2. The applicant shall be the holder of the health food approval certificate. 3. To apply for changing the contents specified in the health food approval certificate and its annexes, the applicant shall submit a written application for change, specifying the specific name, reasons and basis of the change, indicating the date of application, and affixing the seal of the applicant. 4. All copies of the application materials shall be stamped with the seal of the applicant. 5. If a test report is required, the test report shall be issued by an institution determined by the US Food and Drug Administration. 7. Application materials for change of domestic health food (1) Change application and matters needing attention for narrowing the scope of applicable people and expanding the scope of inapplicable people (2) Change application for changing food consumption (product specifications remain unchanged) (3) Change application for changing product specifications, shelf life and quality standards (4) Change application for adding functional items of health food (5) Change application for changing product name (6) Applicant's change application. 2. Change the name, reasons and basis of specific matters. 3. A copy of the applicant's ID card, business license or legal registration certificate of other institutions. 4 copies of the approval documents of health food and its attachments. 5. Draft health food labels and instructions to be revised, with detailed revision instructions. 5. Provide the certificate of the change of the applicant's name and/or address issued by the local administrative department for industry and commerce. Eight. Imported health food 1 Requirements and description of application materials for change. The functional name, raw (auxiliary) materials, technology, eating method, expanding the range of suitable people, narrowing the range of unsuitable people and other contents that may affect the safety and function of health food specified in the approval certificate of health food shall not be changed. 2. The applicant shall be the holder of the health food approval certificate. 3. To apply for changing the contents specified in the health food approval certificate and its annexes, the applicant shall submit a written application for change, specifying the specific name, reasons and basis of the change, indicating the date of application, and affixing the seal of the applicant. 4. All copies of the application materials shall be stamped with the seal of the applicant. 5. If a test report is required, the test report shall be issued by an institution determined by the US Food and Drug Administration. 6. If the applicant entrusts a domestic agency to handle the change, the original power of attorney shall be provided (the power of attorney shall meet the requirements of new product application materials). 7. The reason and basis for the change shall include the certificate issued by the management organization of the country (or region) where the product is produced, which shall be notarized by the notary office of the country where the product is produced and confirmed by the embassy (consulate) in China. 8. Labels, instructions (samples) and quality standards approved by the product producing country (region) shall be accompanied by a Chinese translation and notarized by a Chinese notary office. 9. All copies of the application materials shall be stamped with the seal of the applicant or domestic agency. Nine. Application materials for change of imported health food (1) Application for change to narrow the scope of application and expand the scope of application and matters needing attention (2) Application for change of consumption (product specification unchanged) (3) Application for change of product specification, shelf life and quality standard (4) Application for change of functional items of health food (5) Application for change of internal production site of health food production enterprises outside China (6) Application for change of product name (7). Requirements and explanations of application materials for the registration of domestic technology transfer products of domestic health foods (1) All application materials shall be stamped with the seals of the transferor and the transferee. (2) The technology transfer contract signed by the transferor and the transferee shall include the following contents: 1. The Transferor shall transfer the formula, production technology, quality standards and all technical data related to the production of the transferred products to the Transferee at its sole discretion, and instruct the Transferee to produce three consecutive batches of qualified products. 2. The Transferor shall promise not to produce and sell the product. (3) The technology transfer contract shall be clear and complete, and shall not be altered, and shall be notarized by a Chinese notary office. (4) The hygiene license issued by the provincial health food production supervision and management department and the certification documents conforming to the "Quality Management Standards for Health Food Production" of the transferee shall be within the validity period, and the enterprise name indicated shall be the same as that of the transferee, and the scope of license shall include the declared products. X. Application materials for registration of domestic health food technology transfer products (1) Application form for registration of health food technology transfer products. (two) a copy of the identity card, business license or other legal registration documents. (3) A valid transfer contract signed by the transferor and the transferee notarized by a notary office. (four) a copy of the transferee's health food hygiene license issued by the provincial health food production supervision and management department. (5) A certificate issued by the provincial health food production supervision and management department that the transferee conforms to the good production practice of health food. (six) the original health food approval documents (including health food approval certificate and its attachments and health food change approval). (seven) three consecutive batches of samples produced by the transferee, the number of which is three times the number required for inspection. Xi。 Requirements and explanations for transferring the application materials of imported health food to China (1) If the applicant entrusts a domestic agency to handle the registration matters, it shall provide the original power of attorney (the power of attorney shall meet the requirements of the application materials of imported products). (2) Where the imported health food is transferred overseas, the contract shall be notarized by the notary office of the country (region) where the transferor is located and confirmed by the embassy (consulate) in China. It should be translated into standard Chinese and notarized by a Chinese notary office. Application materials for registration of imported health food technology transfer products (1) Application form for registration of health food technology transfer products. (two) a copy of the identity card, business license or other legal registration documents. (3) A valid transfer contract signed by the transferor and the transferee notarized by a notary office. (four) a copy of the transferee's health food hygiene license issued by the provincial health food production supervision and management department. (5) A certificate issued by the provincial health food production supervision and management department that the transferee conforms to the good production practice of health food. (six) the original health food approval documents (including health food approval certificate and its attachments and health food change approval). (seven) three consecutive batches of samples produced by the transferee, the number of which is three times the number required for inspection. (8) A copy of the registration certificate of the resident representative office of a foreign enterprise in China shall be provided for the registration of the resident representative office of a foreign manufacturer in China. Where an overseas production enterprise entrusts a domestic agency to handle registration matters, it shall provide the notarized original power of attorney and a copy of the business license of the entrusted agency. Wait!