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Pharmaceutical & Cosmetic
Good Preparing Practice for Pharmaceutical Preparations in Medical Institutions (for trial implementation)
    Pubtime: 2012-03-20

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 product. The products or their containers shall not be contaminated by lubricant and coolant used in the equipment.

Article 29 Equipment, facilities and instruments appropriate for the variety of the pharmaceutical preparation prepared shall be available in preparation and testing of pharmaceutical preparations.

Article 30 The range of application and precision of the instruments, meters, weighing and measuring devices used for production and testing shall satisfy the preparation and testing requirements. Each of them shall be labeled and certified, and calibrated as scheduled. The calibration record shall be kept for at least one year.

Article 31 Various rules for equipment management shall be established; a standard operation procedure shall be formulated. Equipment shall be managed by designated persons,and regularly repaired ,maintained and recorded.

Chapter 5 Materials
Article 32 There should be written procedures for materials management covering purchasing, receiving, storage, distribution and use, ect..

Article 33 Materials used for preparation of pharmaceutical preparations shall meet the requirements for pharmaceutical purpose and may not have adverse effects on the quality of pharmaceutical preparations.

Article 34 Chinese crude drug materials used for preparation of pharmaceutical preparations shall be purchased according to the quality specifications and appropriately stored.

Article 35 All kinds of materials shall be strictly managed. Conforming materials, materials to be tested and nonconforming materials/ Materials quarantined, released and rejected shall be stored separately with identifiable and clear marks. Nonconforming/Rejected materials shall be timely disposed of.

Article 36 All kinds of materials shall be appropriately stored based on their nature and use. Materials with specific requirements for temperature and humidity shall be stored in accordance with specified conditions. Volatile materials shall be stored in the way to avoid contaminating other materials. No materials may be stored outdoors.

Article 37 Materials shall be stored in accordance within shelf life. If there is any exceptional case during the storage period, test shall be conducted timely.

Article 38 Labels and insert sheets of pharmaceutical preparations must be consistent with the content, format and text approved by the drug regulatory department, and may not be altered arbitrarily; they shall be stored in designated cabinets under the custody of a designated person and may not be lost.
Chapter 6 Hygiene and Sanitation
Article 39 Hygiene and sanitation measures shall be taken to avoid contamination, and written procedures shall be established for the pharmaceutical preparation laboratory, and responsible persons shall be designated.

Article40 Irrelevant articles or materials may not be stored in a pharmaceutical preparation work room. Waste materials generated from preparation shall be timely disposed.

Article 41 Change rooms, bathrooms and toilets shall not adversely affect clean rooms (areas).

Article 42 Cleaning procedures shall be established for the pharmaceutical preparation laboratory, equipment and containers, etc., including methods, procedures and intervals, detergents or disinfectants, and the cleaning method and storage place for cleaning tools.

Article 43 Clean rooms (areas) shall be regularly disinfected. The disinfectants used shall not cause contamination on equipment, materials and finished products. The different sorts of disinfectants shall be used alternatively so as to prevent development of resistant strains of microorganisms.

Article 44 Material, style and wearing of protective garments shall be adapted to the operation and cleanliness class.
The garment materials used in clean areas shall be smooth, free from static electricity and shedding no fibers or particulate matters. Garments for aseptic purpose shall cover hair, beard and feet completely and shall retain particles shed by the body. Interchange of the garments for different operations and different cleanliness class shall not be allowed.
Garments used for production of different cleanliness shall be regularly laundered and arranged separately, and disinfected or sterilized if necessary. No additive particulate matters shall be brought to garments during washing and sterilizing.
Article 45 Access to clean rooms (areas) is only limited to preparing personnel of the room or other authorized personnel.

Article 46 Personnel entering clean rooms (areas) are not allowed to use cosmetics or wear. Operators are not permitted to contact products with bare hands.

Article 47 Health files shall be established for preparing personnel, who shall receive health checkup at least once a year. Any person with an infectious disease, skin disease or open lesion on exposed surface of the body shall not be allowed to engage in preparation of pharmaceutical preparations.

Chapter 7 Documentation
Article 48 The following documents shall be available in a pharmaceutical preparation laboratory.

(1) A pharmaceutical Preparation Certificate for Medical Institution, application documents and records of verification and acceptance as well as rectification;
(2) Application and approval documents for preparation varieties;
(3) Documents and records of annual inspection, random inspection, supervision and check over the pharmaceutical preparation laboratory.

Article 49 Various Systems and records for preparation management and quality management shall be established for the pharmaceutical preparation laboratory.

(1) Written procedures and records for use and maintenance of operating rooms, facilities and equipment of the pharmaceutical preparation unit;
(2) Written procedures and records for acceptance of materials, preparation, testing,distribution, dispatch of finished products and handling of feedbacks and complaints from user departments and patients;
(3) Written procedures and records for rework, management of substandard products, returning materials to the warehouse, claiming damage and handling of exceptional cases;
(4) Written procedures and records for observation of retention samples;
(5) Written procedures and record for hygiene management of internal and external environment, equipment and personnel of the pharmaceutical preparation laboratory;
(6) Written procedures and records for trainings in the Practice and professional skills.

Article 50 Documents for preparation management of a pharmaceutical preparation mainly include:
(1) A preparation procedure and a standard operation procedure:
The preparation procedure covers: name, dosage form, formula, operational requirements for preparation process of the pharmaceutical preparation, specifications of raw materials, semi-finished and finished products, technical parameters as well as storage cautions, and requirements of containers and packaging materials for finished products ect..
The standard operation procedure covers: specifications and requirements for unit operations involved in the process of preparation (e.g. heating, stirring, shaking and mixing).

(2) Preparation record
The preparation record (pharmaceutical preparation sheet) includes: number and name of the pharmaceutical preparation, date of preparation, lot number of the pharmaceutical preparation, name and operation record of relevant equipment, quantity of used raw materials, quantity of finished products and semi-finished products, preparation process control records, records of handling exceptional cases and signatures of operators, checkers and site cleaner of all working procedures.

Article 51 Quality management documents for preparing a pharmaceutical preparation mainly include:
(1) Quality specifications and testing procedures for materials, semi-finished and finished products;
(2) Observation record for stability of the preparation;
(3) Testing record.

Article 52 Requirements for formulating documents of preparation quality management of a pharmaceutical preparation are as follows:
(1) Documents shall be formulated in accordance with the requirements of the Drug Administration Law and relevant laws, regulations and rules.
(2) Written procedures for document management shall be established. Only the approved current documents shall be used. Obsolete and outdated documents shall not be present at working site but retained in archive for reference.
(3) Responsibilities for formulating, reviewing and approving documents shall be clearly defined and the documents shall be signed by responsible persons.
(4) Relevant preparation records and quality test records shall be fully archived and kept for at least two years for future reference.

Chapter 8 Preparation Management
Article 53 Preparation procedures and standard operation procedure may not be modified without authorization. If any modification is needed, the written procedures for review and approval shall be followed.

Article 54 Batch refers to a defined quantity of preparations with homogeneous characteristics and quality within specified limits, prepared continuously in the same preparation cycle. A batch number shall be assigned to each batch of preparation.

Article 55 Each batch of pharmaceutical preparations shall be checked for balance between input and output materials. If there is significant discrepancy of any batch, the cause must be investigated and clarified, and the batch can be treated as normal only after reasonable explanations are given and no potential quality risk is confirmed.

Article 56 The following measures shall be taken in preparation to prevent products from contamination and mix-up:
(1) The site shall be cleared and the site-clearing record shall be filled out each time after preparation. It shall be confirmed each time before preparation that all remaining matters from previous batch have been cleared up;
(2) Different pharmaceutical preparations (including a pharmaceutical preparation with different specifications) shall not be prepared in the same operating room at the same time.
If this cannot be avoided, preparation must be carried out on different working tables and measures shall be taken to prevent against contamination or mix up;
(3) In process of preparation, the cross-contamination caused by flying powders generated from weighing, sifting and pulverization shall be avoided.
(4) Containers used in the process of preparation must have marks specifying the name, batch number, status and quantity of materials.

Article 57 Process water shall be appropriate to the preparation procedures and meet the quality standards, which shall be regularly tested. The testing frequency shall be decided on the basis of the validation results.

Article 58 Each batch of pharmaceutical preparations shall come with a complete record showing each step of preparation. The operator shall fill in the record in time with legible handwriting, true information and complete data. The record shall be signed by the operator, checker and site clearing person. It shall be well maintained, and shall not be damaged and altered. In case of correction, the original information shall be recognizable and the person concerned shall sign where correction is made.

Article 59 Validations of preparation processes, key facilities and equipment shall follow the written protocol. Revalidation shall be conducted when any change occurs that may affect preparation quality , e.g. the changes of preparation processes, quality control methods, main raw materials and excipients or preparation equipment ect. Revalidation shall be conducted at scheduled intervals of preparation. All validation records shall be archived.
Chapter 9 Quality Management and Self-testing
Article 60 The quality management department is responsible for the quality management in the entire process of preparing pharmaceutical preparations. Its main responsibilities include:
(1) To establish tasks and responsibilities of the quality management organization;
(2) To decide whether materials and intermediate products can be used;
(3) To investigate and solve serious quality problems of pharmaceutical preparations;
(4) To examine the records of the entire preparation process after a pharmaceutical preparation passes testing and decide whether to release and use the pharmaceutical preparation;
(5) To review the procedure for handling of the rejected products and monitor its implementation.

Article 61 The testing laboratory is responsible for testing in the entire process of preparing pharmaceutical preparations. Its main responsibilities include:
(1) To establish and revise in-house criteria for materials, intermediates and finished products and standard operation procedures for testing, sampling and sample retention;
(2) To establish the procedures for controlling testing equipment, instruments, reagents, testing solutions, standard substances (or reference substances), titration solutions, culture media and experimental animals, ect;
(3) To conduct the sampling, testing and retaining of samples and issue the above testing reports;
(4) To monitor the dust particles and microbes/microorganisms in the clean room (area);
(5) To evaluate the stability of raw materials, intermediates and finished products and to provide data for determining storage duration of materials and shelf-life of pharmaceutical preparations;
(6) To define responsibilities of personnel of the testing laboratory.

Article 62 The quality management department shall organize self-testing/self-inspection on a regular basis. Self-testing shall be carried out according to the preset procedure and particulars specified to verify conformance to the Practice.
There shall be records for self-testing. A report shall be made at the completion of a self-testing, including evaluation and corrective actions.

Chapter 10 Management of Use
Article 63 Shelf-life of a pharmaceutical preparation in a medical institution shall be specified in accordance with the principles formulated by the drug regulatory department and in view of the characteristics of dosage forms and stability testing results of the drug substance and pharmaceutical preparation.

Article 64 A complete record or evidences shall be provided for allocation of a pharmaceutical preparation. The record or evidences shall include name of the user department, and name, batch number, specification and quantity of the pharmaceutical preparation. Where a pharmaceutical preparation is found to have quality problems during use, the quality management organization shall handle the problem timely. The pharmaceutical preparation involved shall be recalled immediately and a recall record shall be filled out. The recall record shall include name, batch number, specifications and quantity of the pharmaceutical preparation, name of the department making the recall, reason for the recall, opinion on handling the case and recall date.

Article 65 Where a pharmaceutical preparation is found to have adverse reactions, the case shall be recorded in accordance with the Provisions for ADR Monitoring and reported the form to a higher body. Original records such as medical record and relevant test and inspection reports shall be retained for at least one year for future reference.

Chapter 11 Supplementary Provisions
Article 66 The terms used in the Practice are defined as follows:
Standard operation procedure (SOP): Authorized written documents in general nature or management regulations giving instructions for performing operations.
Preparation procedure: Made for each pharmaceutical preparation; standard operation for preparing the pharmaceutical preparation, including material input, preparation process and packaging of finished products.
Materials: Drug substances/Starting materials, excipients, packaging materials, etc.
Validation: A series of documented actions for proving that any procedure, preparation process, equipment, material, activity or system actually leads to the expected result.
Clean room (area): A room (area) with defined environmental control of particulate and microbial contamination constructed and used in such a way as to reduce the introduction, generation, and retention of contaminants within the room (area).
General area(s): Area(s) outside the clean area; if the air cleanliness class is not specified, they shall meet relevant hygienic requirements.
Process water: Water used in the process of preparing pharmaceutical preparations, including drinking water, purified water and water for injection.
Purified water: Water obtained for pharmaceutical purposes through distillation method, ion exchange technique, reversed osmosis process or other suitable methods, without any additives.
Quality management department/organization: A group of responsible persons from the department of pharmacy, the pharmaceutical preparation laboratory and testing laboratory of a medical institution; it is set up to strengthen quality management of pharmaceutical preparations.

Article 67 The State Food and Drug Administration is responsible for interpretation of the Practice.

Article 68 The Practice shall go into effect as of the date of promulgation.

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