they musthave ultra clean conditions and superclean environment.
Article 30Pharmaceutical enterprises are required to have their own qualityinspection organ and personnel, as well as necessary instrument andequipment to ensure the quality of their products.Article 31Traditional Chinese medicine factories (including those traditionalChinese medicine workshops in Western medicine factories) must not onlymeet the requirements stipulated in Articles 28, 29, 30 and 32 of theseMeasures but also abide by the following stipu-lations:(1) Raw medicinal herbs must be pretreated by way of picking, sorting,washing and baking according to the relevant requirements.(2) See to it that the processing of traditional Chinese medicine intoready-to-use forms (including batching, grinding and packaging) shall bedone in an environment free from contamination.(3) Traditional Chinese medicine technical personnel shall be put incharge of quality control of the Chinese medicine produced in the Westernmedicine factories.Article 32Medicines must be made in accordance with the verified standards andthrough the fixed technical processes. If a pharmaceutical factory intendsto make any change in the production technique which may affect thequality of the medicine, it is required to submit an application to theadministrative department of health at the level of the province,autonomous region or municipality directly under the Central Governmentfor examination and approval.Article 33Pharmaceutical enterprises are required to have a complete productionrecord and lab testing record on file. These records shall be kept for oneyear after the expiry date of the recorded batch of medicine. With respectto medicines without expiry dates, their records shall be kept for 3years.Article 34It is required that all raw materials and additives needed in theproduction of medicines, the containers and packaging material that maydirectly contact the medicine must meet the requirements of the statepharmacopoeia or other pharmaceutical standards. Pharmaceutical factoriesthat plan to use other kinds of materials are required to report theirplans to the administrative department of health for the record.Article 35Pharmaceutical enterprises must strengthen medicine quality control. Allkinds of medicines are subject to quality inspection by their own medicineinspection organs before leaving the production premises. A quality tag orlab testing report shall be put in the interior package of qualityproducts. Those medicines that fail to pass the quality inspection shallnot be allowed to leave the production premises.
【章名】Chapter VII Administration of Pharmaceutical Trading Enterprises
Article 36Pharmaceutical trading enterprises shall be staffed with full timepharmaceutical technical personnel who must meet the followingqualifications:(1) A wholesale pharmaceutical trading enterprise shall set up qualityinspection organs which shall be put under the charge of professionalpharmacists of Chinese or Western medicine.(2) A retail pharmaceutical trading enterprise shall be staffed with apharmacist or a Chinese medicine pharmacist or a full time pharmaceuticalstaff worker who has been examined and registered by the administrativedepartment of health at or above county level.(3) Non-pharmaceutical workers newly recruited or staffed to engage inpharmaceutical preparation, purchasing, storage keeping or marketing ofmedicines are required to go through professional training before they areallowed to work independently.Article 37The business premises, facilities, storage facility and clean environmentof a pharmaceutical trading enterprise must meet the followingrequirements:(1) The storage facilities must meet the requirements by the physicalproperties and chemical characters of medicines. The storage must be wellequipped against dust, rats and deterioration. For those medicines whichneed to be kept away from light and in low temperature, there must belight lock and thermal protective storage devices.(2) A pharmaceutical trading enterprise that also deals in othermerchandise is required to install separate counters for thesemerchandise. No medley of medicine and other articles in the same countershall be allowed.Article 38Pharmaceutical trading enterprises may prepare or process Chinese medicine(including slicing, roasting, baking, shimmering, etc.) or make upprescriptions for patients. However, they may not make any ready-for-useChinese medicine for sale.Article 39Pharmaceutical trading enterprises are required to establish a strictquality checking system and a storage system which includes stock checkingin and out and stock protection.Article 40Pharmaceutical trading enterprises must examine carefully the stock ofmedicine prior to its purchase. The items for examination shall includeits name, producer's name, batch number, quality certificate, registereddocument (number) of approval, registered trade mark, packing and exteriorquality. With respect to Chinese medicinal materials, it is required toexamine the packing which must include its name, place of origin, name ofconsignor and quality inspection mark.
【章名】Chapter VIII Administration of Medicaments Prepared by Medical Treatment Units
Article 41Medical treatment units that prepare their own medicaments shall meet thefollowing requirements:(1) the post in charge of medicament preparation and inspection inhospitals at or above the county level (including these medical treatmentunits with more than 100 wardbeds in factories, mines, enterprises orinstitutions) shall be held by a person who bears at least the title ofsenior pharmacist.Such a post in a hospital under the county level must be held by a personwho bears at least the title of pharmacist.(2) preparation of medicaments must be made in a proper building withadequate facilities and in clean and tidy environment. Places forpreparation of sterilized medicaments must have a locker room, bufferroom, wash room, preparation room, filling and sealing room, sterilizationroom, packing room and air-conditioning. Places for preparation ofinfusion and transfusion medicaments are required to have supercleanconditions.Article 42In preparing medicaments, it is required to strictly abide by theoperating rules, quality inspection rules and hygiene rules. It isrequired to have detailed and complete records for the preparation of eachbatch of medicament.Article 43The medical treatment units that prepare their own medicaments arerequired to have appropriate medicament inspection labs.The medicine inspection lab shall sign and issue a quality certificate forthose medicaments that have passed the inspection and may be adopted forclinical application. Rejects shall not be allowed for clinical use.Article 44Medical treatment units may prepare only those medicaments that are to beused clinically or in research by themselves and that are not available onthe market or insufficiently supplied. These medicaments may not go to themarket or do so in a devious manner.Article 45Medical treatment units are required to prepare their medicaments forclinical use in conformity with the norms for the preparation of clinicalmedicaments stipulated by the administrative department of health at thelevel of the province, autonomous region or municipality directly underthe Central Government and report to the local administrative departmentof health for the record.
Article 46In medical treatment units, no divisions shall be allowed to prepare andsupply clinical medicaments except the division of pharmacy and thedivision of radioisotope.
【章名】Chapter IX Penalty Provisions
Article 47Violation of Article 15 of the Pharmaceutical Administration Law andviolation of Chapter VIII of the same law related to the administration ofadvertisements shall have disciplinary sanctions imposed by theadministration department for industry and commerce; violation of thePharmaceutical Administration Law and these Measures shall havediscipl