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药品生产质量管理规范附录1(2010 年修订)ISPE翻译英文版本(二)

时间:2011年12月31日 ⁄ 分类: GMP 评论:0
  

第四章 隔离操作技术

  

Chapter 4 Isolator technology

  

第十四条 高污染风险的操作宜在隔离操作器中完成。隔离操作器及其所处环境的设计,应当能够保证相应区域空气的质量达到设定标准。传输装置可设计成单门或双门,也可是同灭菌设备相连的全密封系统。

  

物品进出隔离操作器应当特别注意防止污染。

  

隔离操作器所处环境取决于其设计及应用,无菌生产的隔离操作器所处的环境至少应为D 级洁净区。

  

Article 14 Operations associated with high contamination risk should be performed inside isoloator. The isolator and the background environment should be designed so that the required air quality for the respective zones can be realised. Transfer devices may vary from a single door or double door designs to fully sealed systems incorporating sterilisation mechanisms.

  

Special attention should be paid to prevent contamination when transferring of materials into and out of the isolator.

  

The air classification required for the background environment depends on the design of the isolator and its application. It should be controlled and for aseptic processing it should be at least grade D.[separator]

  

第十五条 隔离操作器只有经过适当的确认后方可投入使用。确认时应当考虑隔离技术的所有关键因素,如隔离系统内部和外部所处环境的空气质量、隔离操作器的消毒、传递操作以及隔离系统的完整性。

  

Article 15 Isolators should be applied for routine operations only after appropriate validation. Validation should take into account all critical factors of isolator technology, for examples, the quality of the air inside and outside (background) the isolator, sanitisation of the isolator, the transfer process and isolator integrity.

  

第十六条 隔离操作器和隔离用袖管或手套系统应当进行常规监测,包括经常进行必要的检漏试验。

  

Article 16 Monitoring should be carried out routinely and should include frequent leak testing of the isolator and glove/sleeve system.

  

 

  

第五章 吹灌封技术

  

Chapter 5 Blow/fill/seal technology

  

第十七条 用于生产非最终灭菌产品的吹灌封设备自身应装有A 级空气风淋装置,人员着装应当符合A/B 级洁净区的式样,该设备至少应当安装在C 级洁净区环境中。在静态条件下,此环境的悬浮粒子和微生物均应当达到标准,在动态条件下,此环境的微生物应当达到标准。

  

用于生产最终灭菌产品的吹灌封设备至少应当安装在D 级洁净区环境中。

  

Article 17 Blow/fill/seal equipment used for aseptic production which is fitted with an effective grade A air shower may be installed in at least a grade C environment, provided that grade A/B clothing is used. Under at rest condition, the suspended particles and microorganism should meet the standards. Under in operation condition, the microorganism should meet the standards.

  

Blow/fill/seal equipment used for the production of products which are terminally sterilised should be installed in at least a grade D environment.

  

第十八条 因吹灌封技术的特殊性,应当特别注意设备的设计和确认、在线清洁和在线灭菌的验证及结果的重现性、设备所处的洁净区环境、操作人员的培训和着装,以及设备关键区域内的操作,包括灌装开始前设备的无菌装配。

  

Article 18 Because of this special technology particular attention should be paid to, at least the following:

  

 equipment design and qualification

  

 validation and reproducibility of cleaning-in-place and sterilisation-in-place

  

 background clean room environment in which the equipment is located

  

 operator training and gowning

  

 operations in the critical zone of the equipment including any aseptic assembly or set-up? prior to the commencement of filling.

  

 

  

第六章 人员

  

Chapter 6 Personnel

  

第十九条 洁净区内的人数应当严加控制,检查和监督应当尽可能在无菌生产的洁净区外进行。

  

Article 19 The total number of personnel shall be rigorously controlled .Inspections and controls should be conducted outside the clean areas as far as possible.

  

第二十条 凡在洁净区工作的人员(包括清洁工和设备维修工)应当定期培训,使无菌药品的操作符合要求。培训的内容应当包括卫生和微生物方面的基础知识。未受培训的外部人员(如外部施工人员或维修人员)在生产期间需进入洁净区时,应当对他们进行特别详细的指导和监督。

  

Article 20 All personnel (including those concerned with cleaning and maintenance) employed in such areas should receive regular training in disciplines relevant to the correct manufacture of sterile products. This training should include reference to hygiene and to the basic elements of microbiology.

  

When outside staff who have not received such training (e.g. building or maintenance contractors) need to be brought in, particular care should be taken over their instruction and supervision.

  

第二十一条 从事动物组织加工处理的人员或者从事与当前生产无关的微生物培养的工作人员通常不得进入无菌药品生产区,不可避免时,应当严格执行相关的人员净化操作规程。

  

Article 21 Personnel who have been engaged in the processing of animal tissue materials or of cultures of micro-organisms other than those used in the current manufacturing process shall not enter sterile-product areas unless rigorous and clearly defined cleaning procedures have been followed.

  

第二十二条 从事无菌药品生产的员工应当随时报告任何可能导致污染的异常情况,包括污染的类型和程度。当员工由于健康状况可能导致微生物污染风险增大时,应当由指定的人员采取适当的措施。

  

Article 22 Personnel involved in the manufacture of sterile preparations should be instructed to report any condition which may cause the shedding of abnormal numbers or types of contaminants. Actions to be taken about personnel who could be introducing undue microbiological hazard should be decided by a designated competent person.

  

第二十三条 应当按照操作规程更衣和洗手,尽可能减少对洁净区的污染或将污染物带入洁净区。

  

Article 23 Changing and washing should follow a written procedure designed to minimize contamination of clean area or carry-through of contaminants to the clean areas.

  

第二十四条 工作服及其质量应当与生产操作的要求及操作区的洁净度级别相适应,其式样和穿着方式应当能够满足保护产品和人员的要求。各洁净区的着装要求规定如下:

  

Article 24 The garment and its quality should be appropriate for the process and the grade of the working area. It should be applied in such a way as to protect the products and personnel from contamination.

  

The description of gowning required for each grade is given below:

  

D 级洁净区:应当将头发、胡须等相关部位遮盖。应当穿合适的工作服和鞋子或鞋套。应当采取适当措施,以避免带入洁净区外的污染物。

  

Grade D:   Hair and, where relevant, beard should be covered. A general protective suit and appropriate shoes or overshoes should be worn. Appropriate measures should be taken to avoid any contamination coming from outside the clean area.

  

C级洁净区:应当将头发、胡须等相关部位遮盖,应当戴口罩。应当穿手腕处可收紧的连体服或衣裤分开的工作服,并穿适当的鞋子或鞋套。工作服应当不脱落纤维或微粒。

  

 Grade C: Hair and where relevant beard and moustache should be covered. A face mask should be worn. A jump suit or two-piece trouser suit, gathered at the wrists and with high neck and appropriate shoes or overshoes should be worn.

  

They should be virtually free of fibres or particulate matter.

  

A/B 级洁净区:应当用头罩将所有头发以及胡须等相关部位全部遮盖,头罩应当塞进衣领内,应当戴口罩以防散发飞沫,必要时戴防护目镜。应当戴经灭菌且无颗粒物(如滑石粉)散发的橡胶或塑料手套,穿经灭菌或消毒的脚套,裤腿应当塞进脚套内,袖口应当塞进手套内。工作服应为灭菌的连体工作服,不脱落纤维或微粒,并能滞留身体散发的微粒。

  

Grade A/B: Headgear should totally enclose h  air and, where relevant, beard and moustache; it should be tucked into the neck of the suit; safety goggles should be worn; a face mask should be worn to prevent the shedding of droplets. Appropriate sterilised, non-powdered rubber or plastic gloves and sterilised or disinfected footwear should be worn. Trouser-legs should be tucked inside the footwear and garment sleeves into the gloves. The sterilized jump suit should be used. The suit should shed virtually no fibres or particulate matter and retain particles shed by the body.

  

第二十五条 个人外衣不得带入通向B 级或C 级洁净区的更衣室。每位员工每次进入A/B 级洁净区,应当更换无菌工作服;或每班至少更换一次,但应当用监测结果证明这种方法的可行性。操作期间应当经常消毒手套,并在必要时更换口罩和手套。

  

Article 25 Outdoor clothing should not be brought into changing rooms leading to grade B and C rooms. Every worker should change clean sterile protective garments at every time when he enters a grade A/B area; or at least once a shift while feasibility of the methods should be verified by the results from monitoring.

  

Gloves should be regularly disinfected during operations. Masks and gloves should be changed when necessary.

  

第二十六条 洁净区所用工作服的清洗和处理方式应当能够保证其不携带有污染物,不会污染洁净区。应当按照相关操作规程进行工作服的清洗、灭菌,洗衣间最好单独设置。

  

Article 26 Clean area garments should be cleaned and handled in such a way that it does not introduce additional contaminants which can later contaminate clean areas. The operations should follow written procedures.

  

Separate laundry facilities for such clothing’s cleaning and sterilisation are desirable.

  
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