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验证与确认的区别
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| validation and qualification ，一般都有验证和确认的意思，既然老外将其分开，那么在翻译为中文的时候就应该将其区分开，请问应该翻译为什么意思，都适用于那些方面？ |
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Analytical Instrument Qualification
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karl2100(金币+1,VIP+0):多谢提供！
karl2100(金币+1,VIP+0):多谢提供！
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http://mediwire.skyscape.com/mai ... mp;ArticleID=187972 As mentioned earlier, processes are "validated" and instruments are "qualified." Analytical instrument qualification (AIQ) provides documented evidence that the instrument performs suitably for its intended purpose and that it is properly maintained and calibrated. Qualification normally is grouped into four distinct phases, design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). A definition and discussion of each of the qualification phases have been covered in previous "Validation Viewpoint" columns and elsewhere and really do not need to be repeated here (2,14). The AAPS publication also does an excellent job of capturing the definition and documentation of each of these phases as well, as an excellent discussion on software validation to which the reader is referred for more information (3). However, there are a couple of other significant areas that the AAPS group focused on that are worth noting; documentation and the categorization of instruments according to the level of qualification required. Both static and dynamic documentation can result from an AIQ. Static documents are generated during the DQ, IQ, and OQ phases and should be kept in a separate qualification binder. Static documents can include such things as user manuals, site requirement documents, etc. Dynamic documents are generated during the OQ and PQ phases, when actual instrument testing takes place. These documents provide a running record for the instrument use and maintenance and should be kept in a system log book with the instrument, available for viewing as necessary by anyone interested (that is, the FDA). These documents also should be appropriately archived for future reference and protection. Instruments were placed into three categories (A, B, and C), again based upon their complexity and proposed level of qualification. The conformance of Group A instruments to user requirements is determined by visual observation; no independent qualification process is required. Examples of Group A instruments include spatulas, ovens, magnetic stirrers, microscopes, and vortex mixers. The conformance of Group B instruments to user requirements is determined according to the instruments' SOP, and their failure usually is readily discernable. Examples of instruments that fall into this category are pH meters, balances, thermometers, refrigerator–freezers, and vacuum ovens. Group C instruments are defined as highly method-specific, complex instruments with conformance determined by their application. Full qualification as outlined in the AAPS report is applied to instruments in this group. Examples include high performance liquid chromatography (HPLC) and gas chromatography (GC) instruments, spectrometers, mass spectrometers, and electron microscopes. [ Last edited by penn007 on 2007-11-12 at 14:23 ] |
5楼2007-11-12 13:56:28
2楼2007-11-12 09:48:22
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tianruibencao(金币+3,VIP+0):感谢你的分享
tianruibencao(金币+3,VIP+0):感谢你的分享
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Qualification: 合格, 鉴定, 判定, 合格证明[证书], 认证，资格证明书 verification 确认, 证实[明, 据] validation 验证 2000版ISO9001标准： 3.8.4 验证 verification 通过提供客观证据(3.8.1)对规定要求(3.1.2)已得到满足的认定 注1：“已验证”一词用于表示相应的状态。 注2：认定可包括下述活动，如： ——变换方法进行计算； ——将新设计规范(3.7.3)与已证实的类似设计规范进行比较； ——进行试验(3.8.3)和演示； ——文件发布前的评审。 3.8.5 确认 validation 通过提供客观证据(3.8.1)对特定的预期用途或应用要求(3.1.2)已得到满足的认定 注1：“已确认”一词用于表示相应的状态。 注2：确认所使用的条件可以是实际的或是模拟的。 3.8.6 鉴定过程 qualification process 证实满足规定要求(3.1.2)的能力的过程(3.4.1) 注1：“已鉴定”一词用于表示相应的状态。 注2：鉴定可涉及到人员、产品(3.4.2)、过程或体系(3.2.1)。 示例：审核员鉴定过程、材料鉴定过程。 |
3楼2007-11-12 13:03:31
Differences: Verification, Validation, Calibration and Qualification
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In Pharmaceutical Indusdry: (因为不同行业有不同的解释） Verification and Validation (V&V) is the process of checking that a product, service, or system meets specifications and that it fulfills its intended purpose. These are critical components of a quality management system such as ISO 9000. Verification is a quality process used to evaluate whether or not a product, service, or system complies with a regulation, specification, or conditions imposed at the start of a development phase. Verification can be in development, scale-up, or production. This is often an internal process. Validation is the process of establishing documented evidence that provides a high degree of assurance that a product, service, or system accomplishes its intended requirements. This often involves acceptance and suitability with external customers. http://www.fda.gov/CDER/GUIDANCE/pv.htm Guideline on General Principles of Process Validation Prospective validation - Validation conducted prior to the distribution of either a new product, or product made under a revised manufacturing process, where the revisions may affect the product's characteristics. Retrospective validation - Validation of a process for a product already in distribution based upon accumulated production, testing and control data. Validation & Calibration: http://www.fda.com/forum/showtopic.php?tid/3496/ Validation: According to FDA glossary, it is "establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes". Calibration: According to the National of Standards and Technology, Calibration is a measurement process that assigns values to the property of an artifact or to the response of an instrument relative to reference standards or to a designated measurement process. The purpose of calibration is to eliminate or reduce bias in the user's measurement system relative to the reference base. The calibration procedure compares an "unknown" or test item(s) or instrument with reference standards according to a specific algorithm. Performance qualification is defined for processes, products and computer systems slightly differently. In your case, probably the definitions in the FDA guidelines for process validation fit best, where it states that "Process performance qualification - Establishing confidence that the process is effective and reproducible". But in simpler words: Validation is the job to create the specifications and then to qualify your process (or whatever you have) including the documentation thereof. Qualification is the process of the actual testing that you perform during validation. And calibration is something you have to do routinely (often specified during validation as well) to keep your instruments accurate with respect to a standard (and therefore validated). validation means documenting to prove suitable for intended purpose and it is generally accepted, following the V model, that this means: DQ URS, FRS, Design IQ OQ PQ is confirming the URS Maintain Train Change control. Calibration is an activity that adjusts a device tool or what ever to correlate its reading to another device which could be an international traceable standard. Confirmation of the calibration can be covered in part of the validation work. All validation work has to be scaled to the system / equipment in question, but should follow the general V model principles. For small hand tools that require calibrating I have created a URS, done a calibration. A small hand tool is not installed anywhere ergo no IQ. The fact that it has been calibrated means that it must function OK this can be the OQ. The PQ confirms that the URS has ben met , so what ever was described as required has be satisfied this can be all manner of odds and ends like power compatibility ease of use etc. Qualification: DQ/IQ/OQ/PQ Installation qualification - Establishing confidence that process equipment and ancillary systems are capable of consistently operating within established limits and tolerances. Process performance qualification - Establishing confidence that the process is effective and reproducible. Product performance qualification - Establishing confidence through appropriate testing that the finished product produced by a specified process meets all release requirements for functionality and safety. [ Last edited by penn007 on 2007-11-12 at 14:24 ] |
4楼2007-11-12 13:13:04