【正文】 road surface of the workshop and transport shall not pollute the pharmaceutical goods’ manufacturing. The overall arrangement of the manufacturing area, administration area, living area and assistant area shall be reasonable arranged and do not interfere each other. Stream of people and material in factory area and workshop shall reasonable. Article 41 The workshop shall take appropriate maintenance, and ensure the maintenance activity may not influence the quality of pharmaceutical goods. Clean or take necessary sterilization to workshop according to detailed written operation procedures. Article 42 The workshop shall have appropriate illumination, temperature, humidity and aeration, to ensure the quality of produced and reserved products and the performance of related equipment shall not be influenced directly or indirectly. Article 43 The design and installation of workshop, establishment shall effective prevent insect or other animal to enter in. Necessary measures shall be taken to prevent of using raticide, insecticide, smoke fumigant and so on which may pollute equipment, material, goods. 13 Article 44 Necessary measures shall be taken to prevent unauthorized person to enter in. Manufacturing, storage and quality control area shall not be the direct gate for staffs not in this area. Article 45 Complete drawing of constructed or reconstructed workshop, public service, fixed pipeline shall be saved. Section 2 Manufacturing Area Article 46 In order to reduce pollution and cross pollution risk, workshop, manufacturing establishment and equipment shall reasonable designed, overall arranged and used according to the characteristic, technique process and corresponding clean level, and in accordance with the following requirements: I. Comprehensive considering the pharmaceutical goods’ characteristic, technique and intending purpose and other factors, to confirm feasibility of using workshop, manufacturing establishment and equipment together, and hing related evaluating report。 VI. Pharmaceutical goods’ manufacturing workshop shall not used for manufacturing nonofficinal used products which may have bad influence to pharmaceutical goods’ quality. Article 47 Manufacturing area and storage area shall have enough space to ensure equipment, material, semifinished product, bulk product and finished product could storage in order, to prevent the confusion, cross pollution of different products or material, to prevent missing or mistake during the operation of manufacturing or quality control. Article 48 Air condition cleanse system shall be equipped according to pharmaceutical goods’ variety, manufacturing operation’s requirement and exterior environment condition which let the manufacturing area can effective aeration, and have temperature, humidity control and atmosphere cleanse filtration, to ensure the manufacturing environment of pharmaceutical goods is in accordance with the requirements. The pressure difference between clean area and nonclean area, clean areas in different level shall not lower than 10 Pascal. When necessary, appropriate pressure difference grads shall also be kept in different functional areas (operation area) with same clean level. Exposure working procedure area for oral liquid and solid preparation, chamber use pharmaceutical goods (including rectal pharmaceutical goods), surface external use pharmaceutical goods and other nonasepsis preparation manufacturing and exposure working procedure area for wrapper material directly contact pharmaceutical goods shall equip according to the requirements of “Asepsis Pharmaceutical Goods” D level clean area in 15 Annex. The enterprise could take appropriate microanism monitor measures according to products’ standard and characteristic. Article 49 Inner surface of clean area (wall, floor, sunshade) shall be slick, noncrack, narrow joint, non granule fell off, prevent stored dust, convenient for effective clean, and take sterilization when necessary. Article 50 The design and installation of every kind of pipeline, lighting establishment, place with a draught and other public establishment shall prevent having the part of not easy to clean, and shall try best to maintain outside the manufacturing area. Article 51 Sewerage shall have appropriate size and install the device of reversing flow. Try best to prevent drain in clear channel, if it is inevitably, the clear channel shall be flat so that it is convenient to clean and sterilize. Article 52 Quantify of preparation’s raw material often carry on in the metage room special designed. Article 53 Operation rooms which produce dust (such as sampling, metage, mix, package of dry material or products rooms and other operation rooms) shall keep paratively negative pressure or take special measure, so as to prevent the diffusion of powder dust, avoid cross pollution and easy to keep clean. Article 54 Pharmaceutical goods’ packaging workshop or area shall be reasonable designed and arranged, to prevent confusion or cross pollution. If there are several packaging lines in one area, isolation measures shall be taken. Article 55 Manufacturing area shall have appropriate light, the light in contact manufacturing area shall satisfy the operation requirements. 16 Article 56 Manufacturing area could set middle control area. However, middle control operation shall not bring quality risk to pharmaceutical goods. Section 3 Storage Area Article 57 Storage area shall have enough space, which ensure the underexamined, qualified, disqualified, withdrew or recalled raw material, wrapper, semifinished product, bulk product and finished product and all kinds of material and products could store in order. Article 58 The design and construct of storage area shall ensure g