Notice of the office of Hunan food and Drug Administration on carrying out the special rectification work of rubber products, biochemical drugs and extracts of traditional Chinese medicine (xsyjb [2017] No. 17)

Food and Drug Administration of all cities and prefectures: In order to continuously standardize the drug production order of our province, strengthen the special rectification of outstanding problems and prevent systemic drug quality risks, according to the drug regulatory work arrangement and deployment of the State Food and Drug Administration in 2017, the provincial food and Drug Administration decided to organize and carry out the special rectification of rubber products, biochemical drugs and traditional Chinese medicine extracts within the scope of the province from March 6 to June 20 The requirements are as follows: 1 Objectives Through the organization and implementation of special rectification actions, in-depth investigation of quality risks and safety risks in the production of rubber products, multi-component biochemical drugs and traditional Chinese medicine extracts, strict investigation and punishment of illegal and illegal production activities in accordance with the law, to ensure the continuous compliance of rubber products, biochemical drugs and traditional Chinese medicine extracts, and strive to improve the production quality management level of enterprises, and further enhance the main body of enterprises Sense of responsibility and honesty II Inspection scope and content (I) rubber product renovation 1 Inspection scope: drug production and use enterprises of donkey hide gelatin, tortoiseshell gum and antler gum in the whole province 2 Key inspection contents of rubber product manufacturers (see attached table 1) (1) raw material sources (farmers, breeding bases, trading companies or foreign imported products), places of origin, acceptance and warehousing; (2) compliance of current production process with registration and approval process, miscellaneous leather picking in raw material pretreatment and use of other miscellaneous leather instead of registration and approval of raw material feeding; (3) quality control of intermediate products, inspection and release of finished products and quality inspection of miscellaneous leather such as cowhide source 3 Key inspection contents of rubber product users (see attached table 2) (1) legal qualification and inspection report of raw material suppliers, as well as quality audit of acceptance and warehousing; (2) quality inspection of leather source and other miscellaneous leather; (3) raw material feeding according to prescription; (4) from January 2016 to the verification date, the material balance among the purchase quantity, usage quantity and inventory quantity of rubber products; 4 The key content of joint inspection of rubber product production and use enterprises (1) the actual performance ability of personnel in production and quality management and other important positions; (2) data management of production control and quality inspection, especially data authority allocation, backup and recovery, modification audit, deletion and traceability, and audit tracking of computerized system; (3) supervise and sample 1 batch of rubber products (including donkey hide gelatin, tortoiseshell gum and antler gum) in stock or reserved samples, and send them to the provincial drug inspection and Research Institute for inspection according to the supplementary inspection approval document (No.: 2012001, 2014013 and 2014014) issued by the State Food and drug administration Meanwhile, donkey hide gelatin shall also be inspected for "identification" in accordance with part I of Chinese Pharmacopoeia (2015 Edition) (2) treatment of biochemical drugs 1 Inspection scope: biochemical drug enterprises in the whole province Biochemical drugs refer to safe, effective and quality controllable drugs which are prepared from organs, tissues, body fluids and secretions of animals through pretreatment, extraction, separation and purification (excerpted from the discussion draft of biochemical drugs appendix issued by State Food and Drug Administration) 2 Key inspection contents (see attached table 3) (1) quality audit of raw material supplier's slaughtering certificate, animal epidemic prevention condition certificate and other legal qualifications, cold chain transportation temperature control, quarantine requirements for human and animal pathogens and quarantine certificate; (2) internal control quality standards for animal organs (including source, character, color, water, impurity, freshness, and requirements for animal species, age, collection position and method, storage method and validity period after collection, etc.); (3) the conformity of the current production process procedures with the registration and approval process, especially the key process parameters, control methods and process validation in the processes of crushing, extraction, purification, virus inactivation, removal and sterilization in the pretreatment and extraction production processes, and whether there are any illegal behaviors such as changing the extraction and purification processes in order to reduce the production cost; (4) from January 2016 to the verification date, whether there is any illegal act of directly refining the extracted liquid purchased from the outside, the material balance between the purchase amount, use amount and inventory amount of raw materials and the production amount, inventory amount and sales volume of preparations; (5) data management of production control and quality inspection, especially data authority distribution, backup and recovery, modification audit, deletion and traceability, and audit trail of computerized system; (6) quality risk assessment and cleaning verification of product co production; (7) extended inspection of raw material suppliers (3) treatment of traditional Chinese medicine extracts 1 Inspection scope: pharmaceutical manufacturers that produce and use traditional Chinese medicine extracts in the whole province Traditional Chinese medicine extract refers to the components such as volatile oil, oil, extract, flow extract, dry extract, effective component, effective part, etc which are prescribed in the national drug standard of Chinese patent medicine and have independent national drug standard and are used for the production of Chinese patent medicine 2 Key contents of production and inspection of traditional Chinese medicine extract (see attached table 4) (1) production and filing of traditional Chinese medicine extract; (2) whether the production of traditional Chinese medicine extract is organized according to the key process data (including main process routes, equipment and key process parameters) and GMP specifications submitted for filing, and whether there is any illegal act of OEM production of traditional Chinese medicine extract; (3) quality inspection and release of traditional Chinese medicine extract; (4) material balance between production, use, inventory and sales volume of traditional Chinese medicine extract for production record from January 2016 to verification date 3 The key contents of the use and filing inspection of Chinese herbal extracts (see attached table 5) (1) the use and filing of Chinese herbal extracts and the audit of suppliers' legal qualification and quality; (2) whether there is any illegal act of purchasing Chinese patent medicines not under the filing management; (3) from January 2016 to now, the material balance between the purchase volume, usage volume and inventory volume of the registered Chinese herbal extracts has been used; (4) the extended inspection on the suppliers of Chinese herbal extracts 4 Data management of production control and quality inspection, especially data authority distribution, backup and recovery, modification audit, deletion and traceability of computerized system data, and audit trail, shall be jointly inspected for the production and use of filed Chinese herbal extracts 3 Work requirements (1) urge the enterprise to conduct self inspection Food and Drug Administration of all cities and prefectures shall, as the case may be, hold symposiums for personnel at key positions of relevant enterprises in their respective jurisdictions to clarify the concept, measures, methods and effectiveness of current drug supervision, guide enterprises to take the initiative to investigate potential risks, formulate effective control measures, continue to produce in compliance with regulations, and constantly enhance the sense of responsibility of enterprises At the same time, enterprises within the jurisdiction are required to carry out self inspection and self correction one by one according to the key inspection contents before April 5, and submit a written self inspection report to the local prefecture food and drug administration (2) to carry out supervision and inspection From April 6 to June 10, the food and Drug Administration of all cities and prefectures shall, in combination with the special rectification requirements and the enterprise self inspection report, supervise and inspect the enterprises within their jurisdiction in flight inspection mode If it is found that the purchased animal organs or traditional Chinese medicine extracts are difficult to trace the source, extended inspection shall be carried out; the provincial food and Drug Administration will take the "double random" way to conduct key supervision and inspection on the relevant enterprises (3) to strictly punish illegal acts All localities shall issue a notice of order for rectification and supervise the implementation of rectification to enterprises that are in general violation of GMP; for enterprises that are in serious non-compliance with GMP, the person in charge of the enterprise and personnel at key positions shall be interviewed, and the provincial food and drug administration shall be requested to withdraw their GMP certificate in accordance with the law; for enterprises that are in serious violation of the relevant provisions of the drug management law, they shall file a case for strict investigation in accordance with the law If the case is serious, it shall be submitted to the provincial food and Drug Administration for revoking its drug production license according to law If a criminal offence is involved, it must be transferred to the public security department for handling The municipal and prefecture food and drug administration shall submit the special inspection summary and relevant statistical statements (including sealed written materials and electronic versions) to the drug production department of the provincial food and drug administration before June 20 Contact person: Li Changlin, contact information: 17479928@qq.com Annex: 1 Statistical table of special remediation of rubber product manufacturers 2 Statistical table of special remediation of rubber product users 3 Statistical table of special remediation of biochemical drugs 4 Statistical table of special remediation of production and filing of traditional Chinese medicine extracts 5 Statistical table of special rectification for use and filing of traditional Chinese medicine extracts, office of Hunan food and drug administration, March 7, 2017