【正文】 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 Annex. The enterprise could take appropriate microorganism 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.Article 56 Manufacturing area could set middle control area. However, middle control operation shall not bring quality risk to pharmaceutical goods.Section 3 Storage AreaArticle 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 good storage condition, and have aeration and lighting establishment. Storage area shall satisfy material or products’ storage condition (such as temperature, humidity, avoid of light) and safety storage requirements, and check and monitor shall be taken.Article 59 High active material or product and printing package material shall storage in safe area.Article 60 Receiving, extending and delivering area shall protect material, product out of influence of weather outside (such as rain, snow). The arrangement and establishment of receiving area shall ensure taking necessary cleaning to the received material’s outside packaging. Article 61 If the underexamined material is stored in separate isolate area, the underexamine area shall have distinct mark, and only authorized person could in and out.Disqualified, withdrew or recalled material or product shall be stored isolated.If other method is used for replacing physics isolation, this method shall have equal security.Article 62 Separate material sampling area is often set up. Air cleaning level of sampling area is the same with the manufacturing requirements. If sample is taken in other area or use other method, pollution or cross pollution shall prevent.Section 4 Quality Control AreaArticle 63 Quality control laboratory is often divided from manufacturing area. Biology examine, microorganism and radioactivity isotope laboratory shall also divided from each other.Article 64 The design of laboratory shall ensure for applying it’s intending purpose, and prevent confusion and cross pollution, enough area shall have for disposing samples, reserved samples and samples for reviewing stability and keeping the records.Article 65 When necessary, set a special instrument room to prevent static, shaking, humid or other outside factors’ disturbance to instrument with high sensitivity.Article 66 The laboratory disposing special goods such as biology samples or radioactivity samples shall in accordance with the related requirements of the country.Article 67 Experiment animal room shall be strictly divided from other area. Its design, construct shall in accordance with the related requirem