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Laws & Regulations - Drugs - Good Preparing Practice for Pharmaceutical Preparations in Medical Institutions (for trial implementation)
Good Preparing Practice for Pharmaceutical Preparations in Medical Institutions (for trial implementation)
2012/3/20 14:34:17¡¡Source: ¡¡Hits:

Chapter 1 General Provisions
Article 1 The Practice is formulated in accordance with the Drug Administration Law of the People¡¯s Republic of China and with reference to the basic principles of the Good Manufacturing Practice for Pharmaceutical Products.

Article 2 Pharmaceutical preparations in medical institutions refer to pharmaceutical preparations based on fixed formula, which are routinely prepared by medical institutions for their own use in light of their clinical needs.
Article 3 To prepare pharmaceutical preparations, a medical institution shall obtain a Pharmaceutical Preparation Certificate for Medical Institution from the drug regulatory department of the province, autonomous region or municipality directly under the Central Government.

Article 4 The State Food and Drug Administration and drug regulatory departments of various provinces, autonomous regions and municipalities directly under the Central Government are responsible for supervision on the quality of pharmaceutical preparations in medical institutions and release of quality announcements.

Article 5 The Practice is the norm for preparation and quality management of pharmaceutical preparations in medical institutions and applies to the entire preparation process of pharmaceutical preparations.

Chapter 2 Organization and Personnel
Article 6 To prepare pharmaceutical preparations, a medical institution shall establish a pharmaceutical preparation laboratory, a drug testing laboratory and a quality management organization at the Department of Pharmacy. Organization and posts shall be clearly defined in specific responsibilities and equipped with certain number of technical professionals with relevant qualifications.

Article 7 The chief of the medical institution is responsible for implementation of the Practice and quality of pharmaceutical preparations.

Article 8 The person in charge of the pharmaceutical preparation laboratory and the person in charge of the testing laboratory shall hold an associate degree or higher degree in pharmacy or a relevant field and have relevant experience in management and the ability to properly decide and handle problems at work.
The heads of pharmaceutical preparation and testing laboratories shall be independent of each other.

Article 9 All personnel engaged in preparation of pharmaceutical preparations and drug testing shall receive professional technical training and acquire the basic theoretical knowledge and operational skills.
    Where there are special requirements for operation and testing personnel engaged in making pharmaceutical preparations, they shall be given specific training.

Article 10 All personnel engaged in preparation of pharmaceutical preparations shall be familiar with the Practice, trained and examined as required in the Practice.

Chapter 3 Buildings and Facilities
Article 11 To ensure the quality of pharmaceutical preparations, the pharmaceutical preparation laboratory shall be kept away from all kinds of contamination sources. The surrounding ground, pavement and vegetation should not contribute to any contamination to the preparation process of pharmaceutical preparations.

Article 12 The pharmaceutical preparation laboratory shall have facilities efficient for preventing contamination and entry of insects and other animals.

Article 13 Building and floor area of the pharmaceutical preparation laboratory shall be appropriate for the dosage form and scale of the pharmaceutical preparation prepared. A change room for the staff shall be provided.

Article 14 All work rooms shall be in a reasonable layout in accordance with the working procedures of the pharmaceutical preparation and requirements for the air cleanliness class. The general area shall be separated from the clean area; preparation and filling shall be separated from labeling and packaging; preparations for internal use shall be separated from those for external use; sterile preparations shall be separated from other preparations.

Article 15 Working procedures shall be appropriately connected and different operating rooms shall be provided for different pharmaceutical preparations according to dosage form. Operator jobs shall be classified according to working procedures.

Article 16 The pharmaceutical preparation laboratory shall be provided with a storeroom for materials and finished products appropriate for the pharmaceutical preparation to be prepared and facilities for ventilation and damp prevention.

Article 17 Pretreatment, extraction and concentration of Chinese crude drugs shall be strictly separated from subsequent working procedures, and facilities efficient for de-dusting and ventilation shall be equipped.

Article 18 In design and construction of the pharmaceutical preparation laboratory, user¡¯s convenience for cleaning shall be considered. The interior surface of a clean room shall be smooth and free from cracks and open joints. The interior surfaces shall not shed particulate matters and shall stand cleaning and disinfecting. The joints between walls and floors are preferably constructed into round corners or by other measures taken to minimize dust accumulation and to clean easily.

Article 19 Pipework, light fittings, ventilation points and other public facilities in a clean room shall be designed and installed to avoid the creation of recesses that are difficult to clean.

Article 20 Air cleanliness shall be classified in accordance with technological requirements of pharmaceutical preparations (see Appendices Table I and Table II). The number of microbes/microorganism and dust particles in the air of the clean room (area) shall meet the requirements, and be tested and recorded periodically.

Article 21 The clean room (area) shall be adequately illuminated. A 300 lux illumination is recommended for the main workshop.

Article 22 Windows, technical interlayer, and connections between indoors pipelines, air vents, lamps and walls or the ceiling shall all be sealed.

Article 23 A certain positive pressure shall be maintained in the clean room (area), to which a certain amount of fresh air shall be supplied.

Article 24 Sinks and floor drains installed in the clean room (area) shall be properly positioned and may not contaminate pharmaceutical preparations. Class 100 clean areas may not have any floor drains.

Article 25 Laboratory animal rooms shall be away from the pharmaceutical preparation laboratory.

Chapter 4 Equipment
Article 26 Selection and installation of equipment shall meet requirements for preparation of pharmaceutical preparations. The equipment shall be easily cleaned, disinfected or sterilized, conveniently operated, repaired and maintained so as to minimize any risk of errors and contamination.

Article 27 The preparation, storage and distribution of purified water and water for injection shall be prevented from microorganism growth and contamination. Storage tanks and distribution pipelines shall be made of non-toxic and corrosion-resistant materials. Concealed space and dead legs shall be avoided in design and installation of pipelines.

Article 28 The surface of equipment directly contacting products shall be smooth and even, easy to be cleaned, disinfected and corrosion resistant, and shall not be reactive or absorptive to the produ

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