| the Registered Document of Approval to the unit.
Article 24
The Registered Document of Approval for a medicine is valid for 5 years, during which time no change of the registration number shall be allowed. The Registered Document of Approval of a medicine shall become invalid if the medicine has not been produced for 3 years.
Article 25
The administrative department of health under the State Council is required to organize investigations of medicines that have been approved for production. The Medicine Appraisal shall revoke the Registered Document of Approval if it discovers by appraisal that the medicine’s curative effects are uncertain, that they produce serious adverse reactions, or that for other reasons they are harmful to people’s health.
Chapter VI Administration of Pharmaceutical Production Enterprises
Article 26
The state shall practise The Norms For Quality Control of Medicine Production. The administrative department of health under the State Council shall formulate The Norms For Quality Control of Medicine Production and supervise the implementation thereof. The departments in charge of the production and trading of medicines may formulate specific rules to guide the gradual implementation of the Norms.
Article 27
All the newly built pharmaceutical factories and the extension or rebuilt workshops of the existing pharmaceutical factories are required to meet the requirements stipulated in the Norms For Quality Control of Medicine Production. The existing pharmaceutical enterprises are required to establish hygiene rules and regulations to ensure medicine quality and strive to meet all the requirements stipulated in the Norms For Quality Control of Medicine Production gradually and in a planned way.
Article 28
Pharmaceutical production enterprises shall be staffed with professional
technical personnel and skilled workers who must meet the following qualifications:(1) a factory manager in charge of pharmaceutical production and quality
control must be familiar with the techniques involved in pharmaceutical production;
(2) the post of the director in charge of pharmaceutical production technology and quality inspection shall be held respectively by a pharmaceutist, an assistant engineer or a herbdruggist, depending on the kind of medicine being produced;
(3) the responsible workshop technician is required to have an education of at least the technical school level and with 5 years or more production experience;
(4) the technical workers are required to go through technical training before they are allowed to operate independently;(5) with respect to those pharmaceutical factories processing traditional Chinese medicines into ready-to-use forms, if they are unable to meet the requirements stated in Item 2 of Article 28 of these Measures, the
relevant posts shall be held by Chinese medicinal herb personnel who are familiar with the properties of the herbal medicine processed, can appraise medicinal herbs and have a mastery of the production techniques. These personnel must be examined by and registered with the administrative department of health above county level.
Article 29
Pharmaceutical enterprises are required to have factory premises, facilities and a sanitary environment to ensure the quality of the medicine. They must be kept clean and tidy. If they are engaged in the preparation of transfusion medicament and powdered injection, they must have ultra clean conditions and superclean environment.
Article 30
Pharmaceutical enterprises are required to have their own quality inspection organ and personnel, as well as necessary instrument and equipment to ensure the quality of their products.
Article 31
Traditional Chinese medicine factories (including those traditional Chinese medicine workshops in Western medicine factories) must not only meet the requirements stipulated in Articles 28, 29, 30 and 32 of these Measures 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 into ready-to-use forms (including batching, grinding and packaging) shall be done in an environment free from contamination.(3) Traditional Chinese medicine technical personnel shall be put in charge of quality control of the Chinese medicine produced in the Western medicine factories.
Article 32
Medicines must be made in accordance with the verified standards and through the fixed technical processes. If a pharmaceutical factory intends to make any change in the production technique which may affect the quality of the medicine, it is required to submit an application to the administrative department of health at the level of the province, autonomous region or municipality directly under the Central Government for examination and approval.
Article 33
Pharmaceutical enterprises are required to have a complete production record and lab testing record on file. These records shall be kept for one year after the expiry date of the recorded batch of medicine. With respect to medicines without expiry dates, their records shall be kept for 3 years.
Article 34
It is required that all raw materials and additives needed in the production of medicines, the containers and packaging material that may directly contact the medicine must meet the requirements of the state pharmacopoeia or other pharmaceutical standards. Pharmaceutical factories that plan to use other kinds of materials are required to report their plans to the administrative department of health for the record.
Article 35
Pharmaceutical enterprises must strengthen medicine quality control. All kinds of medicines are subject to quality inspection by their own medicine inspection organs before leaving the production premises. A quality tag or lab testing report shall be put in the interior package of quality products. Those medicines that fail to pass the quality inspection shall not be allowed to leave the production premises.
Chapter VII Administration of Pharmaceutical Trading Enterprises
Article 36
Pharmaceutical trading enterprises shall be staffed with full time pharmaceutical technical personnel who must meet the following qualifications:(1) A wholesale pharmaceutical trading enterprise shall set up quality
inspection organs which shall be put under the charge of professional pharmacists of Chinese or Western medicine.(2) A retail pharmaceutical trading enterprise shall be staffed with a pharmacist or a Chinese medicine pharmacist or a full time pharmaceutical staff worker who has been examined and registered by the administrative
department of health at or above county level.(3) Non-pharmaceutical workers newly recruited or staffed to engage in pharmaceutical preparation, purchasing, storage keeping or marketing of medicines are required to go through professional training before they are allowed to work independently.
Article 37
The business premises, facilities, storage facility and clean environment of a pharmaceutical trading enterprise must meet the following requirements:
(1) The storage facilities must meet the requirements by the physical properties and chemical characters of medicines. The storage must be well equipped against dust, rats and deterioration. For those medicines which need to be kept away from light and in low temperature, there must be light lock and thermal protective storage devices.
(2) A pharmaceutical trading enterprise that also deals in other merchandise is required to install separate counters for these merchandise. No medley of medicine and other articles in the same counter shall be allowed.
Article 38
Pharmaceutical trading enterprises may prepare or process Chinese medicine (including slicing, roasting, baking, shimmering, etc.) or make up prescriptions for patients. However, they may not make any ready-for-use Chinese medicine for sale.
Article 39 Pharmaceutical trading enterprises are required to establish a strict
quality checking system and a storage system which includes stock checking in and out and stock protection.
Article 40
Pharmaceutical trading enterprises must examine carefully the stock of medicine prior to its purchase. The items for examination shall include its name, producer’s name, batch number, quality certificate, registered document (number) of approval, registered trade mark, packing and exterior quality. With respect to Chinese medicinal materials, it is required to examine the packing which must include its name, place of origin, name of consignor and quality inspection mark.
Chapter VIII Administration of Medicaments Prepared by Medical Treatment Units
Article 41
Medical treatment units that prepare their own medicaments shall meet the following requirements:(1) the post in charge of medicament preparation and inspection in
hospitals at or above the county level (including these medical treatment units with more than 100 wardbeds in factories, mines, enterprises or institutions) shall be held by a person who bears at least the title of senior pharmacist. Such a post in a hospital under the county level must be held by a person who bears at least the title of pharmacist.(2) preparation of medicaments must be made in a proper building with
adequate facilities and in clean and tidy environment. Places for preparation of sterilized medicaments must have a locker room, buffer room, wash room, preparation room, filling and sealing room, sterilization room, packing room and air-conditioning. Places for preparation of infusion and transfusion medicaments are required to have superclean conditions.
Article 42
In preparing medicaments, it is required to strictly abide by the operating rules, quality inspection rules and hygiene rules. It is required to have detailed and complete records for the preparation of each batch of medicament.
共4页 上一页 1 2 3 4 下一页 |
